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A Phase III Trial For Patients With Metastatic Breast Cancer

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00191152
Collaborator
(none)
475
Enrollment
65
Locations
2
Arms
81
Duration (Months)
7.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/ capecitabine doublets, with crossover to the alternate agent. The experimental arm will receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75 mg/m2 IV day 1 over 1 hour repeated every three weeks. The comparator arm will receive docetaxel 75 mgm/m2 IV day 1 over 1 hour and oral capecitabine 1000 mg/m2 twice daily, days 1 through 14 repeated every three weeks. Patients who progress on the experimental arm, will be treated with capecitabine as dosed on the comparator arm. Patients who progress on the comparator arm will be treated with gemcitabine as dosed on the experimental arm.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
475 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Trial of Gemcitabine Plus Docetaxel vs. Docetaxel Plus Capecitabine in Metastatic Breast Cancer in 1st and 2nd
Study Start Date :
Feb 1, 2002
Actual Primary Completion Date :
Nov 1, 2008
Actual Study Completion Date :
Nov 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Gemcitabine + Docetaxel

Drug: gemcitabine
1000 mg/m2, intravenous (IV) day 1 and day 8 every 21 days until disease progression
Other Names:
  • LY188011
  • Gemzar

    • Drug: docetaxel
    75 mg/m2, intravenous (IV), every 21 days until disease progression
    Active Comparator: Capecitabine + Docetaxel

    Drug: docetaxel
    75 mg/m2, intravenous (IV), every 21 days until disease progression

    Drug: capecitabine
    1000 mg/m2, by mouth (PO) twice a day (BID), days 1-14, every 21 days until disease progression

    Outcome Measures

    Primary Outcome Measures

    1. Time to Disease Progression (Initial Treatment) [Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months)]

      Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment.

    Secondary Outcome Measures

    1. Time to Disease Progression (Crossover Treatment) [Date of first dose of crossover treatment to date of first-documented disease progression after receiving first crossover treatment or date of death due to study disease, whichever came first (up to 82 months)]

      For crossover treatment, time to disease progression (TTDP) was defined as the number of months between the first dose date of crossover treatment and the date of disease progression or the date of death due to disease under study, whichever came first. TTDP for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. TTDP censored at earliest of: 1)date of death not due to disease; or 2)date of last contact for participants alive without disease progression; or 3)start date of other anti-tumor therapy due to progression.

    2. Progression-Free Survival (Initial Treatment) [Date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 82 months)]

      For initial treatment, progression-free survival (PFS) was defined as the number of months between the date of randomization and the date of first documented disease progression or the date of death due to any cause, whichever came first. Time to PFS was censored at the earliest of: 1) date of last contact for participants alive without disease progression; or 2) start date of other anti-tumor therapy for progression; or 3) first dose date of crossover treatment.

    3. Progression-Free Survival (Crossover Treatment) [First dose date of crossover treatment to date of first-documented progression after receiving crossover treatment or date of death due to any cause, whichever came first (up to 82 months)]

      For crossover treatment, progression-free survival (PFS) was defined as the number of months between first dose date of crossover treatment and date of documented disease progression or date of death due to any cause, whichever came first. PFS for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. PFS was censored at the earliest of: 1) date of last contact for participants alive without disease progression; or 2) start date of other anti-tumor therapy for participants with documented disease progression.

    4. Duration of Response (Initial Treatment) [Date of response (CR or PR) until the first date of documented progression or death from any cause (up to 82 months)]

      Among tumor responders, duration of tumor response was measured from the date of response (complete response [CR] or partial response [PR] until the first date of documented progression or death from any cause. Duration of response was censored at the earliest of: 1) date of last contact for participants alive without disease progression (DP); or 2) start date of other anti-tumor therapy for DP; or 3) dose date of crossover treatment.

    5. Duration of Response (Crossover Treatment) [Date of CR or PR until first date of recurrent or progressive disease after receiving crossover treatment was objectively documented or date of date due to any cause, whichever came first (up to 82 months)]

      At crossover treatment, duration of response was measured from the time criteria were met for complete response (CR) or partial response (PR), until first date that recurrent or progressive disease was objectively documented or date of death due to any cause, whichever came first. This definition only applied to those who crossed over & achieved CR or PR in crossover treatment. Duration of response censored at earliest of: 1) date of last contact for those alive without disease progression; or 2) start date of other anti-tumor therapy for documented disease progression.

    6. Overall Survival [Date of randomization to date of death from any cause (up to 82 months)]

      Overall survival time was defined as the number of months between the date of randomization and the date of death due to any cause. The overall survival time was censored at the date of last contact for participants who were still alive.

    7. Best Overall Response (Initial Treatment) [Best response from start of treatment until disease progression/recurrence (up to 82 months)]

      Best overall response was the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria.

    8. Best Overall Response (Crossover Treatment) [Best response from start of treatment until disease progression/recurrence (up to 82 months)]

      Best overall response was the best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response assessed using RECIST criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria.

    9. Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Initial Treatment) [Baseline until crossover treatment began (up to 82 months)]

      KPS ranges from 0 to 100, subdivided into three categories: incapacitated (0-40), self-care (50-70), and normal activity (80-100).

    10. Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Crossover Treatment) [First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 moths)]

      KPS ranges from 0 to 100, subdivided into three categories: incapacitated (0-40), self-care (50-70), and normal activity (80-100).

    11. Summary of Changes in Rotterdam Symptom Checklist (RSCL) by Treatment (Initial Treatment) [Baseline until crossover treatment began (up to 82 months)]

      RSCL includes 4 scales to assess quality of life (QOL) endpoints: 1) a 23-item physical distress level with scale score ranges from 23 to 92 [low score represents better QOL] 2)a 7-item psychological distress level with scale score ranges from 7 to 28[low score represents better QOL] 3)8-item activity level with scale score ranges from 8 to 32 [high score represents better QOL]; 1-item overall valuation of life with score range from 1 to 7 [low score represents better QOL].

    12. Summary of Changes in Rotterdam Symptom Checklist by Treatment (Crossover Treatment) [First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 months)]

      RSCL includes 4 scales to assess quality of life (QOL) endpoints: 1) a 23-item physical distress level with scale score ranges from 23 to 92 [low score represents better QOL] 2)a 7-item psychological distress level with scale score ranges from 7 to 28[low score represents better QOL] 3)8-item activity level with scale score ranges from 8 to 32 [high score represents better QOL]; 1-item overall valuation of life with score range from 1 to 7 [low score represents better QOL].

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologic or cytologic confirmation of breast cancer with locally advanced and/or metastatic disease

    • Patients may have received prior neo-adjuvant or adjuvant taxane regimen as long as it has been greater than or equal to 6 months since completion of the regimen

    • Patients may have had 0-1, but no more than one prior course of chemotherapy for metastatic disease

    • Patients must have either measurable or non-measurable (evaluable) disease

    • Prior radiation therapy allowed of less than 25% of the bone marrow

    Exclusion Criteria:

    • Second primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence)

    • Parenchymal or leptomeningeal brain metastases

    • Peripheral neuropathy greater than or equal to grade 2

    • Prior treatment with gemcitabine and capecitabine will not be allowed. Prior treatment with a taxane in the metastatic setting will not be allowed. Prior taxane therapy in the neo-adjuvant or adjuvant setting is allowed if completion of therapy greater than or equal to 6 months prior to enrollment.

    • Active cardiac disease not controlled by therapy and/or myocardial infarction within the preceding 6 months.

    • Concomitant Herceptin is not allowed

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Glendale Arizona United States
    2 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Fort Smith Arkansas United States
    3 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Hot Springs Arkansas United States
    4 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Little Rock Arkansas United States
    5 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Springdale Arkansas United States
    6 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Berkeley California United States
    7 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Fountain Valley California United States
    8 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Highland California United States
    9 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. La Jolla California United States
    10 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Los Angeles California United States
    11 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Rancho Mirage California United States
    12 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph San Diego California United States
    13 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Santa Rosa California United States
    14 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Sylmar California United States
    15 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph Denver Colorado United States
    16 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph Torrington Connecticut United States
    17 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Fort Myers Florida United States
    18 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Hollywood Florida United States
    19 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph Orlando Florida United States
    20 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Idaho Falls Idaho United States
    21 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. South Bend Indiana United States
    22 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Iowa City Iowa United States
    23 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Louisville Kentucky United States
    24 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Metairie Louisiana United States
    25 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Royal Oak Michigan United States
    26 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Southfield Michigan United States
    27 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Columbia Missouri United States
    28 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. St. Louis Missouri United States
    29 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Fremont Nebraska United States
    30 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Voorhees New Jersey United States
    31 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. New York New York United States
    32 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Springfield Ohio United States
    33 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician.c Dunmore Pennsylvania United States
    34 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Franklin Pennsylvania United States
    35 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Johnstown Pennsylvania United States
    36 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Kittanning Pennsylvania United States
    37 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Pittsburgh Pennsylvania United States
    38 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Charleston South Carolina United States
    39 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Knoxville Tennessee United States
    40 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Memphis Tennessee United States
    41 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Nashville Tennessee United States
    42 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Austin Texas United States
    43 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Dallas Texas United States
    44 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Lubbock Texas United States
    45 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. San Antonio Texas United States
    46 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Madison Wisconsin United States
    47 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Milwaukee Wisconsin United States
    48 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Capital Federal Argentina
    49 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Mendoza Argentina
    50 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rosario Argentina
    51 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Santa Fe Argentina
    52 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Waratah New South Wales Australia
    53 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Redcliffe Queensland Australia
    54 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Ashford South Australia Australia
    55 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Porto Alegre Brazil
    56 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Seoul Korea, Republic of
    57 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Acapulco Mexico
    58 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Mexico City Mexico
    59 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Michoacan Mexico
    60 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Toluca Mexico
    61 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. San Juan Puerto Rico
    62 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Kaohsiung Taiwan
    63 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Taichung Taiwan
    64 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. Taipei Taiwan
    65 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph Tao-Yuan Taiwan

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00191152
    Other Study ID Numbers:
    • 4703
    • B9E-US-S188
    First Posted:
    Sep 19, 2005
    Last Update Posted:
    Dec 24, 2009
    Last Verified:
    Dec 1, 2009
    Additional relevant MeSH terms:
    Breast Neoplasms
    Gemcitabine
    Capecitabine
    Docetaxel

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Not all participants who completed initial treatment went on to crossover treatment. Per protocol, participants had the option to go off study without receiving crossover treatment.
    Arm/Group Title Gemcitabine Plus Docetaxel Docetaxel Plus Capecitabine
    Arm/Group Description Initial treatment: Gemcitabine 1000 milligrams per meter squared (mg/m2),intravenous (IV) on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2 IV on Day 1 every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins. Crossover treatment: capecitabine 1000 mg/m2 by mouth (PO) twice a day (BID), Days 1-14, every 21 days until PD at which time all treatment is discontinued. PD during crossover was defined as the Response Evaluation Criteria in Solid Tumors (RECIST) guideline with the tumor measurement at the start of crossover treatment (or end of initial treatment) considered as the crossover baseline, with subsequent tumor measurements during crossover treatment compared to the crossover baseline. Initial treatment: Docetaxel 75 milligrams per meter squared (mg/m2), intravenous (IV) on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth (PO), twice a day (BID), Days 1-14, every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins. Crossover treatment: gemcitabine 1000 mg/m2, IV, Days 1 and 8, every 21 days. This treatment continues until PD at which time all treatment is discontinued.
    Period Title: Initial Treatment
    STARTED 239 236
    Received Initial Treatment 236 227
    COMPLETED 98 83
    NOT COMPLETED 141 153
    Period Title: Initial Treatment
    STARTED 77 81
    Received Treatment 76 80
    COMPLETED 50 53
    NOT COMPLETED 27 28

    Baseline Characteristics

    Arm/Group Title Gemcitabine Plus Docetaxel Docetaxel Plus Capecitabine Total
    Arm/Group Description Initial treatment: Gemcitabine 1000 milligrams per meter squared (mg/m2), intravenous (IV) on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2 IV on Day 1 every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins. Crossover treatment: capecitabine 1000 mg/m2 by mouth (PO)twice a day (BID), Days 1-14, every 21 days until progressive disease (PD) at which time all treatment is discontinued. Initial treatment: Docetaxel 75 milligrams per meter squared (mg/m2), intravenous (IV) on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth (PO), twice a day (BID),Days 1-14, every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins. Crossover treatment: gemcitabine 1000 mg/m2, IV, Days 1 and 8, every 21 days. This treatment continues until PD at which time all treatment is discontinued. Total of all reporting groups
    Overall Participants 239 236 475
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    55.8
    (11.77)
    54.6
    (11.60)
    55.2
    (11.69)
    Sex: Female, Male (Count of Participants)
    Female
    237
    99.2%
    1
    0.4%
    238
    50.1%
    Male
    2
    0.8%
    235
    99.6%
    237
    49.9%
    Region of Enrollment (participants) [Number]
    United States
    173
    72.4%
    166
    70.3%
    339
    71.4%
    Taiwan
    15
    6.3%
    18
    7.6%
    33
    6.9%
    Mexico
    14
    5.9%
    15
    6.4%
    29
    6.1%
    Puerto Rico
    4
    1.7%
    1
    0.4%
    5
    1.1%
    Argentina
    11
    4.6%
    13
    5.5%
    24
    5.1%
    Brazil
    1
    0.4%
    1
    0.4%
    2
    0.4%
    Australia
    11
    4.6%
    12
    5.1%
    23
    4.8%
    Korea, Republic of
    10
    4.2%
    10
    4.2%
    20
    4.2%
    Karnofsky Performance Status-Baseline (units on a scale) [Number]
    <=60 Needs increasing assistance up to Death (0)
    0
    0
    0
    70 - Unable to carry on normal activity
    16
    15
    31
    80 - Activity with effort; some signs of disease
    44
    40
    84
    90 - Normal activity; minor signs of disease
    101
    101
    202
    100 - Normal no complaints; no evidence of disease
    74
    75
    149
    Missing
    4
    5
    9
    Race/Ethnicity (participants) [Number]
    Caucasian
    160
    66.9%
    158
    66.9%
    318
    66.9%
    African Descent
    23
    9.6%
    12
    5.1%
    35
    7.4%
    Oriental
    28
    11.7%
    30
    12.7%
    58
    12.2%
    Hispanic
    26
    10.9%
    36
    15.3%
    62
    13.1%
    Other
    2
    0.8%
    0
    0%
    2
    0.4%

    Outcome Measures

    1. Secondary Outcome
    Title Time to Disease Progression (Crossover Treatment)
    Description For crossover treatment, time to disease progression (TTDP) was defined as the number of months between the first dose date of crossover treatment and the date of disease progression or the date of death due to disease under study, whichever came first. TTDP for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. TTDP censored at earliest of: 1)date of death not due to disease; or 2)date of last contact for participants alive without disease progression; or 3)start date of other anti-tumor therapy due to progression.
    Time Frame Date of first dose of crossover treatment to date of first-documented disease progression after receiving first crossover treatment or date of death due to study disease, whichever came first (up to 82 months)

    Outcome Measure Data

    Analysis Population Description
    ITT population: all randomized participants. Censored participants in crossover treatment: 13 in capecitabine arm; 10 in gemcitabine arm.
    Arm/Group Title Capecitabine Gemcitabine
    Arm/Group Description capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued. gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
    Measure Participants 77 81
    Median (95% Confidence Interval) [months]
    4.51
    2.34
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Capecitabine, Gemcitabine
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.145
    Comments
    Method Log Rank
    Comments
    2. Secondary Outcome
    Title Progression-Free Survival (Initial Treatment)
    Description For initial treatment, progression-free survival (PFS) was defined as the number of months between the date of randomization and the date of first documented disease progression or the date of death due to any cause, whichever came first. Time to PFS was censored at the earliest of: 1) date of last contact for participants alive without disease progression; or 2) start date of other anti-tumor therapy for progression; or 3) first dose date of crossover treatment.
    Time Frame Date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 82 months)

    Outcome Measure Data

    Analysis Population Description
    ITT: all randomized participants. Censored participants (initial treatment): 64 in gemcitabine/docetaxel arm; 80 in docetaxel/capecitabine arm.
    Arm/Group Title Gemcitabine Plus Docetaxel Docetaxel Plus Capecitabine
    Arm/Group Description gemcitabine 1000 mg/m2, intravenous on days 1 and 8 every 21 days plus docetaxel 75 mg/m2 intravenous on day 1 every 21 days. This treatment continues until progression of disease at which time crossover treatment begins. docetaxel 75 mg/m2, intravenous, on day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
    Measure Participants 239 236
    Median (95% Confidence Interval) [months]
    9.01
    8.88
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Capecitabine, Gemcitabine
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.361
    Comments
    Method Log Rank
    Comments
    3. Secondary Outcome
    Title Progression-Free Survival (Crossover Treatment)
    Description For crossover treatment, progression-free survival (PFS) was defined as the number of months between first dose date of crossover treatment and date of documented disease progression or date of death due to any cause, whichever came first. PFS for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. PFS was censored at the earliest of: 1) date of last contact for participants alive without disease progression; or 2) start date of other anti-tumor therapy for participants with documented disease progression.
    Time Frame First dose date of crossover treatment to date of first-documented progression after receiving crossover treatment or date of death due to any cause, whichever came first (up to 82 months)

    Outcome Measure Data

    Analysis Population Description
    ITT population: all randomized participants. Censored participants, crossover treatment: 13 in capecitabine arm; 10 in gemcitabine arm.
    Arm/Group Title Capecitabine Gemcitabine
    Arm/Group Description capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued. gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
    Measure Participants 77 81
    Median (95% Confidence Interval) [months]
    4.51
    2.34
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Capecitabine, Gemcitabine
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.145
    Comments
    Method Log Rank
    Comments
    4. Primary Outcome
    Title Time to Disease Progression (Initial Treatment)
    Description Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment.
    Time Frame Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months)

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat (ITT) population: all randomized participants. Censored participants in initial treatment: 68 gemcitabine/docetaxel arm; 83 docetaxel/capecitabine arm.
    Arm/Group Title Gemcitabine Plus Docetaxel Docetaxel Plus Capecitabine
    Arm/Group Description gemcitabine 1000 milligrams per meter squared (mg/m2) intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins. docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease, at which time crossover treatment begins.
    Measure Participants 239 236
    Median (95% Confidence Interval) [months]
    9.28
    8.88
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Capecitabine, Gemcitabine
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.385
    Comments
    Method Log Rank
    Comments
    5. Secondary Outcome
    Title Duration of Response (Initial Treatment)
    Description Among tumor responders, duration of tumor response was measured from the date of response (complete response [CR] or partial response [PR] until the first date of documented progression or death from any cause. Duration of response was censored at the earliest of: 1) date of last contact for participants alive without disease progression (DP); or 2) start date of other anti-tumor therapy for DP; or 3) dose date of crossover treatment.
    Time Frame Date of response (CR or PR) until the first date of documented progression or death from any cause (up to 82 months)

    Outcome Measure Data

    Analysis Population Description
    ITT population: participants with CR or PR as best overall response (initial treatment). Censored participants: 16 in gemcitabine/docetaxel arm; 30 in docetaxel/capecitabine arm.
    Arm/Group Title Gemcitabine Plus Docetaxel Docetaxel Plus Capecitabine
    Arm/Group Description gemcitabine 1000 mg/m2, intravenous on days 1 and 8 every 21 days plus docetaxel 75 mg/m2 intravenous on day 1 every 21 days. This treatment continues until progression of disease at which time crossover treatment begins. docetaxel 75 mg/m2, intravenous, on day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
    Measure Participants 77 85
    Median (95% Confidence Interval) [months]
    9.11
    10.39
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Capecitabine, Gemcitabine
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.377
    Comments
    Method Log Rank
    Comments
    6. Secondary Outcome
    Title Duration of Response (Crossover Treatment)
    Description At crossover treatment, duration of response was measured from the time criteria were met for complete response (CR) or partial response (PR), until first date that recurrent or progressive disease was objectively documented or date of death due to any cause, whichever came first. This definition only applied to those who crossed over & achieved CR or PR in crossover treatment. Duration of response censored at earliest of: 1) date of last contact for those alive without disease progression; or 2) start date of other anti-tumor therapy for documented disease progression.
    Time Frame Date of CR or PR until first date of recurrent or progressive disease after receiving crossover treatment was objectively documented or date of date due to any cause, whichever came first (up to 82 months)

    Outcome Measure Data

    Analysis Population Description
    ITT population: participants with CR or PR as best overall response at crossover treatment. Censored participants: 4 in capecitabine arm; 2 in gemcitabine arm.
    Arm/Group Title Capecitabine Gemcitabine
    Arm/Group Description capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued. gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
    Measure Participants 11 7
    Median (95% Confidence Interval) [months]
    25.89
    42.50
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Capecitabine, Gemcitabine
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.446
    Comments
    Method Log Rank
    Comments
    7. Secondary Outcome
    Title Overall Survival
    Description Overall survival time was defined as the number of months between the date of randomization and the date of death due to any cause. The overall survival time was censored at the date of last contact for participants who were still alive.
    Time Frame Date of randomization to date of death from any cause (up to 82 months)

    Outcome Measure Data

    Analysis Population Description
    Intent to treat population: all randomized participant. Censored participants: 75 in gemcitabine/docetaxel arm; 72 in docetaxel/capecitabine arm.
    Arm/Group Title Gemcitabine Plus Docetaxel Docetaxel Plus Capecitabine
    Arm/Group Description gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins. docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
    Measure Participants 239 236
    Median (95% Confidence Interval) [months]
    22.99
    23.29
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Capecitabine, Gemcitabine
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.785
    Comments
    Method Log Rank
    Comments
    8. Secondary Outcome
    Title Best Overall Response (Initial Treatment)
    Description Best overall response was the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria.
    Time Frame Best response from start of treatment until disease progression/recurrence (up to 82 months)

    Outcome Measure Data

    Analysis Population Description
    ITT population.
    Arm/Group Title Gemcitabine Plus Docetaxel Docetaxel Plus Capecitabine
    Arm/Group Description gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins. docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
    Measure Participants 239 236
    Complete Response (confirmed)
    6
    2.5%
    6
    2.5%
    Partial Response (confirmed)
    71
    29.7%
    79
    33.5%
    Stable Disease
    96
    40.2%
    90
    38.1%
    Progressive Disease
    32
    13.4%
    27
    11.4%
    Unknown
    34
    14.2%
    34
    14.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Capecitabine, Gemcitabine
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.364
    Comments
    Method Fisher Exact
    Comments
    9. Secondary Outcome
    Title Best Overall Response (Crossover Treatment)
    Description Best overall response was the best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response assessed using RECIST criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria.
    Time Frame Best response from start of treatment until disease progression/recurrence (up to 82 months)

    Outcome Measure Data

    Analysis Population Description
    Only included participants who crossed over from initial treatment to crossover treatment.
    Arm/Group Title Capecitabine Gemcitabine
    Arm/Group Description capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued. gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
    Measure Participants 77 81
    Complete Response (confirmed)
    1
    0.4%
    1
    0.4%
    Partial Response (confirmed)
    10
    4.2%
    6
    2.5%
    Stable Disease
    19
    7.9%
    20
    8.5%
    Progressive Disease
    34
    14.2%
    36
    15.3%
    Unknown
    13
    5.4%
    18
    7.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Capecitabine, Gemcitabine
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.446
    Comments
    Method Fisher Exact
    Comments
    10. Secondary Outcome
    Title Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Initial Treatment)
    Description KPS ranges from 0 to 100, subdivided into three categories: incapacitated (0-40), self-care (50-70), and normal activity (80-100).
    Time Frame Baseline until crossover treatment began (up to 82 months)

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population, initial treatment, participants with KPS at baseline and end of initial treatment.
    Arm/Group Title Gemcitabine Plus Docetaxel Docetaxel Plus Capecitabine
    Arm/Group Description gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins. docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
    Measure Participants 212 214
    Baseline
    90.85
    (8.159)
    90.09
    (8.335)
    Change from Baseline
    -3.30
    (9.259)
    -3.27
    (9.118)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Capecitabine, Gemcitabine
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.990
    Comments
    Method Mixed Models Analysis
    Comments
    11. Secondary Outcome
    Title Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Crossover Treatment)
    Description KPS ranges from 0 to 100, subdivided into three categories: incapacitated (0-40), self-care (50-70), and normal activity (80-100).
    Time Frame First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 moths)

    Outcome Measure Data

    Analysis Population Description
    Participants with KPS at baseline (conclusion of initial treatment) and end of crossover treatment
    Arm/Group Title Capecitabine Gemcitabine
    Arm/Group Description capecitabine 1000 mg/m2, by mouth two times per day, days 1-14, every 21 days gemcitabine 1000 mg/m2 intravenously, days 1 and 8, every 21 days
    Measure Participants 66 63
    Baseline
    89.09
    (7.174)
    87.94
    (9.360)
    Change from Baseline
    -0.30
    (7.839)
    -1.27
    (9.068)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Capecitabine, Gemcitabine
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.117
    Comments
    Method Mixed Models Analysis
    Comments
    12. Secondary Outcome
    Title Summary of Changes in Rotterdam Symptom Checklist (RSCL) by Treatment (Initial Treatment)
    Description RSCL includes 4 scales to assess quality of life (QOL) endpoints: 1) a 23-item physical distress level with scale score ranges from 23 to 92 [low score represents better QOL] 2)a 7-item psychological distress level with scale score ranges from 7 to 28[low score represents better QOL] 3)8-item activity level with scale score ranges from 8 to 32 [high score represents better QOL]; 1-item overall valuation of life with score range from 1 to 7 [low score represents better QOL].
    Time Frame Baseline until crossover treatment began (up to 82 months)

    Outcome Measure Data

    Analysis Population Description
    Participants with RSCL at baseline and end of initial treatment.
    Arm/Group Title Gemcitabine Plus Docetaxel Docetaxel Plus Capecitabine
    Arm/Group Description gemcitabine 1000 mg/m2, intravenous, on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, on Day 1 every 21 days. This treatment continues until progression of disease at which time crossover treatment begins. docetaxel 75 mg/m2, intravenous on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth, twice a day, days 1-14, every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
    Measure Participants 117 118
    Baseline
    68.09
    (25.103)
    72.32
    (23.693)
    Change from Baseline
    2.42
    (27.093)
    -2.68
    (26.685)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Capecitabine, Gemcitabine
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.801
    Comments
    Method Mixed Models Analysis
    Comments
    13. Secondary Outcome
    Title Summary of Changes in Rotterdam Symptom Checklist by Treatment (Crossover Treatment)
    Description RSCL includes 4 scales to assess quality of life (QOL) endpoints: 1) a 23-item physical distress level with scale score ranges from 23 to 92 [low score represents better QOL] 2)a 7-item psychological distress level with scale score ranges from 7 to 28[low score represents better QOL] 3)8-item activity level with scale score ranges from 8 to 32 [high score represents better QOL]; 1-item overall valuation of life with score range from 1 to 7 [low score represents better QOL].
    Time Frame First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 months)

    Outcome Measure Data

    Analysis Population Description
    Participants with RSCL at baseline (conclusion of initial treatment)and end of crossover treatment
    Arm/Group Title Capecitabine Gemcitabine
    Arm/Group Description capecitabine 1000 mg/m2, by mouth twice day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued. gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
    Measure Participants 30 24
    Baseline
    75.00
    (20.876)
    76.39
    (17.663)
    Change from Baseline
    -2.78
    (21.029)
    -0.69
    (27.133)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Capecitabine, Gemcitabine
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.190
    Comments
    Method Mixed Models Analysis
    Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description A participant was randomized to comparator arm but treated with experimental treatment and thus included in the comparator arm ITT population (disposition and efficacy tables) and included in the experimental arm of treated population (AE tables). This results in an inconsistency between number of participants analysed and participant flow module.
    Arm/Group Title Gemcitabine Plus Docetaxel Docetaxel Plus Capecitabine
    Arm/Group Description Initial treatment: Gemcitabine 1000 milligrams per meter squared (mg/m2), intravenous (IV) on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2 IV on Day 1 every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins. Crossover treatment: capecitabine 1000 mg/m2 by mouth (PO) twice a day (BID), Days 1-14, every 21 days until PD at which time all treatment is discontinued. Initial treatment: Docetaxel 75 milligrams per meter squared (mg/m2), intravenous (IV) on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth (PO), twice a day (BID), Days 1-14, every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins. Crossover treatment: gemcitabine 1000 mg/m2, IV, Days 1 and 8, every 21 days. This treatment continues until PD at which time all treatment is discontinued.
    All Cause Mortality
    Gemcitabine Plus Docetaxel Docetaxel Plus Capecitabine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Gemcitabine Plus Docetaxel Docetaxel Plus Capecitabine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 72/237 (30.4%) 55/226 (24.3%)
    Blood and lymphatic system disorders
    Anaemia 2/237 (0.8%) 2 1/226 (0.4%) 1
    Disseminated intravascular coagulation 1/237 (0.4%) 1 0/226 (0%) 0
    Febrile neutropenia 9/237 (3.8%) 10 9/226 (4%) 9
    Leukocytosis 1/237 (0.4%) 1 0/226 (0%) 0
    Leukopenia 6/237 (2.5%) 9 2/226 (0.9%) 3
    Lymphopenia 1/237 (0.4%) 1 0/226 (0%) 0
    Neutropenia 25/237 (10.5%) 38 7/226 (3.1%) 11
    Thrombocytopenia 2/237 (0.8%) 2 0/226 (0%) 0
    Cardiac disorders
    Atrial fibrillation 0/237 (0%) 0 1/226 (0.4%) 1
    Cardiac failure congestive 2/237 (0.8%) 2 0/226 (0%) 0
    Cardiac tamponade 1/237 (0.4%) 1 0/226 (0%) 0
    Cardiopulmonary failure 1/237 (0.4%) 1 0/226 (0%) 0
    Pericardial effusion 4/237 (1.7%) 4 0/226 (0%) 0
    Tachycardia 1/237 (0.4%) 1 0/226 (0%) 0
    Gastrointestinal disorders
    Abdominal pain 2/237 (0.8%) 2 0/226 (0%) 0
    Diarrhoea 2/237 (0.8%) 2 4/226 (1.8%) 4
    Diverticulitis 1/237 (0.4%) 2 0/226 (0%) 0
    Enterocolitis 0/237 (0%) 0 1/226 (0.4%) 1
    Gastrointestinal haemorrhage 0/237 (0%) 0 1/226 (0.4%) 1
    Intestinal perforation 0/237 (0%) 0 1/226 (0.4%) 1
    Nausea 2/237 (0.8%) 2 2/226 (0.9%) 2
    Oesophagitis 0/237 (0%) 0 1/226 (0.4%) 1
    Pancreatitis 1/237 (0.4%) 1 0/226 (0%) 0
    Ruptured diverticulum 1/237 (0.4%) 1 0/226 (0%) 0
    Volvulus of bowel 0/237 (0%) 0 1/226 (0.4%) 1
    Vomiting 4/237 (1.7%) 4 3/226 (1.3%) 3
    General disorders
    Asthenia 0/237 (0%) 0 1/226 (0.4%) 1
    Catheter site erythema 1/237 (0.4%) 1 0/226 (0%) 0
    Chest pain 0/237 (0%) 0 1/226 (0.4%) 1
    Fatigue 3/237 (1.3%) 3 2/226 (0.9%) 2
    Lethargy 1/237 (0.4%) 1 0/226 (0%) 0
    Malaise 0/237 (0%) 0 1/226 (0.4%) 1
    Mucosal inflammation 1/237 (0.4%) 1 0/226 (0%) 0
    Multi-organ failure 1/237 (0.4%) 1 0/226 (0%) 0
    Oedema peripheral 1/237 (0.4%) 1 0/226 (0%) 0
    Pyrexia 4/237 (1.7%) 4 5/226 (2.2%) 5
    Infections and infestations
    Bronchopneumonia 1/237 (0.4%) 1 0/226 (0%) 0
    Catheter related infection 0/237 (0%) 0 1/226 (0.4%) 1
    Catheter sepsis 1/237 (0.4%) 1 0/226 (0%) 0
    Catheter site infection 2/237 (0.8%) 2 0/226 (0%) 0
    Cellulitis 0/237 (0%) 0 3/226 (1.3%) 3
    Cellulitis orbital 0/237 (0%) 0 1/226 (0.4%) 1
    Clostridium colitis 2/237 (0.8%) 2 0/226 (0%) 0
    Escherichia infection 1/237 (0.4%) 1 0/226 (0%) 0
    Infection 1/237 (0.4%) 1 3/226 (1.3%) 3
    Lobar pneumonia 1/237 (0.4%) 1 0/226 (0%) 0
    Neutropenic sepsis 2/237 (0.8%) 2 0/226 (0%) 0
    Periorbital cellulitis 0/237 (0%) 0 1/226 (0.4%) 1
    Pneumonia 3/237 (1.3%) 3 3/226 (1.3%) 3
    Pyelonephritis 1/237 (0.4%) 1 0/226 (0%) 0
    Sepsis 2/237 (0.8%) 2 0/226 (0%) 0
    Septic shock 2/237 (0.8%) 2 0/226 (0%) 0
    Urinary tract infection 2/237 (0.8%) 2 1/226 (0.4%) 1
    Urosepsis 1/237 (0.4%) 1 0/226 (0%) 0
    Injury, poisoning and procedural complications
    Seroma 0/237 (0%) 0 1/226 (0.4%) 1
    Investigations
    Blood alkaline phosphatase increased 1/237 (0.4%) 1 0/226 (0%) 0
    Haematocrit decreased 1/237 (0.4%) 1 1/226 (0.4%) 1
    Metabolism and nutrition disorders
    Anorexia 2/237 (0.8%) 2 2/226 (0.9%) 2
    Dehydration 4/237 (1.7%) 4 2/226 (0.9%) 2
    Failure to thrive 0/237 (0%) 0 1/226 (0.4%) 1
    Hyperglycaemia 0/237 (0%) 0 1/226 (0.4%) 1
    Musculoskeletal and connective tissue disorders
    Chest wall pain 0/237 (0%) 0 1/226 (0.4%) 1
    Neck pain 0/237 (0%) 0 1/226 (0.4%) 1
    Pain in extremity 1/237 (0.4%) 1 0/226 (0%) 0
    Nervous system disorders
    Cerebral haemorrhage 0/237 (0%) 0 1/226 (0.4%) 1
    Peripheral sensory neuropathy 1/237 (0.4%) 1 1/226 (0.4%) 1
    Renal and urinary disorders
    Bilateral hydronephrosis 1/237 (0.4%) 1 0/226 (0%) 0
    Renal insufficiency 3/237 (1.3%) 3 0/226 (0%) 0
    Renal tubular necrosis 1/237 (0.4%) 1 0/226 (0%) 0
    Reproductive system and breast disorders
    Breast pain 0/237 (0%) 0 1/226 (0.4%) 1
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome 1/237 (0.4%) 1 0/226 (0%) 0
    Chronic obstructive airways disease exacerbated 1/237 (0.4%) 3 0/226 (0%) 0
    Dyspnoea 4/237 (1.7%) 4 2/226 (0.9%) 2
    Dyspnoea exacerbated 1/237 (0.4%) 1 0/226 (0%) 0
    Hypoxia 0/237 (0%) 0 2/226 (0.9%) 2
    Lung infiltration 1/237 (0.4%) 1 1/226 (0.4%) 1
    Orthopnoea 1/237 (0.4%) 1 0/226 (0%) 0
    Pleural effusion 3/237 (1.3%) 3 1/226 (0.4%) 1
    Pulmonary embolism 5/237 (2.1%) 5 0/226 (0%) 0
    Tachypnoea 1/237 (0.4%) 1 0/226 (0%) 0
    Skin and subcutaneous tissue disorders
    Alopecia 0/237 (0%) 0 1/226 (0.4%) 1
    Palmar-plantar erythrodysaesthesia syndrome 0/237 (0%) 0 4/226 (1.8%) 4
    Skin ulcer 0/237 (0%) 0 1/226 (0.4%) 1
    Vascular disorders
    Deep vein thrombosis 1/237 (0.4%) 1 2/226 (0.9%) 2
    Embolism 1/237 (0.4%) 1 0/226 (0%) 0
    Hypotension 0/237 (0%) 0 1/226 (0.4%) 1
    Jugular vein thrombosis 0/237 (0%) 0 1/226 (0.4%) 1
    Phlebothrombosis 1/237 (0.4%) 1 0/226 (0%) 0
    Shock 1/237 (0.4%) 1 0/226 (0%) 0
    Subclavian vein thrombosis 0/237 (0%) 0 1/226 (0.4%) 1
    Thrombophlebitis 1/237 (0.4%) 1 0/226 (0%) 0
    Thrombosis 0/237 (0%) 0 2/226 (0.9%) 2
    Venous occlusion 1/237 (0.4%) 1 0/226 (0%) 0
    Other (Not Including Serious) Adverse Events
    Gemcitabine Plus Docetaxel Docetaxel Plus Capecitabine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 233/237 (98.3%) 221/226 (97.8%)
    Blood and lymphatic system disorders
    Anaemia 113/237 (47.7%) 278 59/226 (26.1%) 110
    Leukopenia 86/237 (36.3%) 294 25/226 (11.1%) 53
    Neutropenia 193/237 (81.4%) 883 73/226 (32.3%) 216
    Thrombocytopenia 70/237 (29.5%) 152 6/226 (2.7%) 13
    Eye disorders
    Lacrimation increased 15/237 (6.3%) 23 29/226 (12.8%) 38
    Gastrointestinal disorders
    Abdominal pain 33/237 (13.9%) 42 30/226 (13.3%) 43
    Constipation 65/237 (27.4%) 100 49/226 (21.7%) 71
    Diarrhoea 111/237 (46.8%) 217 108/226 (47.8%) 221
    Dyspepsia 21/237 (8.9%) 28 28/226 (12.4%) 44
    Nausea 113/237 (47.7%) 233 118/226 (52.2%) 248
    Stomatitis 47/237 (19.8%) 92 60/226 (26.5%) 113
    Vomiting 71/237 (30%) 120 74/226 (32.7%) 134
    General disorders
    Asthenia 45/237 (19%) 104 32/226 (14.2%) 61
    Chest pain 15/237 (6.3%) 23 12/226 (5.3%) 13
    Fatigue 129/237 (54.4%) 285 120/226 (53.1%) 224
    Mucosal inflammation 38/237 (16%) 81 65/226 (28.8%) 117
    Oedema 31/237 (13.1%) 77 27/226 (11.9%) 46
    Oedema peripheral 54/237 (22.8%) 90 44/226 (19.5%) 67
    Pain 25/237 (10.5%) 45 18/226 (8%) 31
    Pyrexia 60/237 (25.3%) 93 33/226 (14.6%) 38
    Rigors 15/237 (6.3%) 22 9/226 (4%) 9
    Infections and infestations
    Candidiasis 5/237 (2.1%) 9 12/226 (5.3%) 14
    Upper respiratory tract infection 17/237 (7.2%) 21 8/226 (3.5%) 8
    Urinary tract infection 13/237 (5.5%) 19 11/226 (4.9%) 11
    Investigations
    Alanine aminotransferase increased 28/237 (11.8%) 42 13/226 (5.8%) 19
    Aspartate aminotransferase increased 21/237 (8.9%) 31 14/226 (6.2%) 22
    Weight decreased 16/237 (6.8%) 23 10/226 (4.4%) 14
    Metabolism and nutrition disorders
    Anorexia 59/237 (24.9%) 122 59/226 (26.1%) 92
    Dehydration 21/237 (8.9%) 24 22/226 (9.7%) 26
    Hyperglycaemia 21/237 (8.9%) 47 15/226 (6.6%) 21
    Hypocalcaemia 10/237 (4.2%) 22 12/226 (5.3%) 17
    Hypokalaemia 13/237 (5.5%) 16 14/226 (6.2%) 17
    Musculoskeletal and connective tissue disorders
    Arthralgia 43/237 (18.1%) 60 39/226 (17.3%) 62
    Back pain 24/237 (10.1%) 34 23/226 (10.2%) 31
    Bone pain 21/237 (8.9%) 29 10/226 (4.4%) 12
    Myalgia 46/237 (19.4%) 105 33/226 (14.6%) 62
    Pain in extremity 25/237 (10.5%) 42 25/226 (11.1%) 31
    Nervous system disorders
    Dizziness 21/237 (8.9%) 24 19/226 (8.4%) 32
    Dysgeusia 32/237 (13.5%) 50 29/226 (12.8%) 39
    Headache 41/237 (17.3%) 53 32/226 (14.2%) 38
    Peripheral sensory neuropathy 78/237 (32.9%) 133 83/226 (36.7%) 141
    Psychiatric disorders
    Depression 16/237 (6.8%) 21 9/226 (4%) 10
    Insomnia 31/237 (13.1%) 38 30/226 (13.3%) 37
    Respiratory, thoracic and mediastinal disorders
    Cough 54/237 (22.8%) 92 45/226 (19.9%) 55
    Dyspnoea 55/237 (23.2%) 81 37/226 (16.4%) 51
    Pharyngolaryngeal pain 20/237 (8.4%) 26 11/226 (4.9%) 17
    Skin and subcutaneous tissue disorders
    Alopecia 86/237 (36.3%) 120 98/226 (43.4%) 127
    Erythema 10/237 (4.2%) 10 15/226 (6.6%) 19
    Nail disorder 38/237 (16%) 70 67/226 (29.6%) 118
    Palmar-plantar erythrodysaesthesia syndrome 15/237 (6.3%) 20 129/226 (57.1%) 370
    Pruritus 14/237 (5.9%) 16 10/226 (4.4%) 11
    Rash 59/237 (24.9%) 82 32/226 (14.2%) 44
    Vascular disorders
    Hypotension 12/237 (5.1%) 13 6/226 (2.7%) 6
    Lymphoedema 14/237 (5.9%) 24 10/226 (4.4%) 12

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 1-800-545-5979
    Email
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00191152
    Other Study ID Numbers:
    • 4703
    • B9E-US-S188
    First Posted:
    Sep 19, 2005
    Last Update Posted:
    Dec 24, 2009
    Last Verified:
    Dec 1, 2009