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Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00149214
Collaborator
(none)
257
Enrollment
11
Locations
2
Arms
65.9
Duration (Months)
23.4
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

An open-label randomized Phase II study in order to explore two different sequential anthracycline-based neoadjuvant treatment regimens in female patients with primary, operable breast cancer (T2-T4/N0-2/M0).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
257 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase 2 Trial of Doxorubicin Plus Pemetrexed Followed by Docetaxel, Versus Doxorubicin Plus Cyclophosphamide Followed by Docetaxel, as Neoadjuvant Treatment for Early Breast Cancer
Study Start Date :
Sep 1, 2005
Actual Primary Completion Date :
Feb 1, 2008
Actual Study Completion Date :
Mar 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: A: Pemetrexed Plus Doxorubicin, Followed by Docetaxel

Drug: pemetrexed
500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4)
Other Names:
  • LY231514, Alimta

    • Drug: doxorubicin
    60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4)

    Drug: docetaxel
    100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
    Active Comparator: B: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel

    Drug: cyclophosphamide
    600 mg/m2, intravenous (IV), every 21 days, 4 cycles (1-4)

    Drug: doxorubicin
    60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4)

    Drug: docetaxel
    100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With a Pathological Complete Response [surgery after eight 21-day cycles of chemotherapy]

      pathological assessment of tissue removed during surgery to determine if tumor tissue is still present after chemotherapy

    Secondary Outcome Measures

    1. Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy [Cycles 1-4 (21-day cycles)]

      The number of participants with a clinical tumor response based on measurement of tumor size after the first sequence of chemotherapy, without a second confirmatory tumor measurement, per protocol.

    2. Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy [Cycles 5-8 (21-day cycles)]

      The number of participants with a clinical tumor response based on measurement of tumor size after the second sequence of chemotherapy, without a second confirmatory tumor measurement required, per protocol.

    3. Number of Patients With Histologically Negative Axillary Lymph Node Status at Surgery [surgery after eight 21-day cycles of chemotherapy]

      Histologically negative is defined as no malignant cells present in the axillary lymph nodes during surgery.

    4. Disease-free Survival [baseline through post surgery, follow-up for 3 years post-surgery (up to 5.2 years after randomization)]

      Disease-free survival is defined as the time from date of study enrollment (randomization) to first date of progressive disease (PD) or death from any cause. PD per Response Evaluation Criteria In Solid Tumors (RECIST) criteria is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For patients not known to have died as of the data cut-off date and who do not have progressive disease, disease-free survival was censored at the last contact date.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically confirmed diagnosis of primary early breast cancer, tumor size greater than or equal to 2 centimeters (cm), of Stages T2-T4/N0-2.

    • Performance status 0-2 Eastern Cooperative Oncology Group (ECOG).

    • Adequate organ function (bone marrow, hepatic, renal, cardiac).

    Exclusion Criteria:

    • Prior anthracyclines as part of prior anticancer therapy.

    • Concurrent antitumor therapy.

    • Second primary malignancy.

    • Serious concomitant systemic disorder.

    • Pre-existing sensorial or motor neuropathy

    • Grade 1.

    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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Baden-Baden Germany 76532
    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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Berlin Germany 10967
    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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hamburg Germany 20357
    4 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Heidelberg Germany D-69115
    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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cremona Italy 26100
    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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rozzano Italy 20089
    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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Moscow Russian Federation 129128
    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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Saint Petersburg Russian Federation 197022
    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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Jaen Spain 23007
    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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sabadell Spain 08208
    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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Valencia Spain 46010

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Chair: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9am - 5pm 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:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT00149214
    Other Study ID Numbers:
    • 7113
    • H3E-MC-S080
    First Posted:
    Sep 8, 2005
    Last Update Posted:
    Mar 21, 2012
    Last Verified:
    Mar 1, 2012
    Additional relevant MeSH terms:
    Breast Neoplasms
    Cyclophosphamide
    Docetaxel
    Doxorubicin
    Pemetrexed

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail The one participant who was randomized to pemetrexed but treated with cyclophosphamide is included in the as randomized group (pemetrexed) for the purposes of the participant flow, excluded from the efficacy analyses (per the protocol), but in the as treated group (cyclophosphamide) for safety analyses.
    Arm/Group Title Pemetrexed Plus Doxorubicin, Followed by Docetaxel Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
    Arm/Group Description pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8) cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
    Period Title: Overall Study
    STARTED 135 122
    COMPLETED 109 105
    NOT COMPLETED 26 17

    Baseline Characteristics

    Arm/Group Title Pemetrexed Plus Doxorubicin, Followed by Docetaxel Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel Total
    Arm/Group Description pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8) cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8) Total of all reporting groups
    Overall Participants 135 122 257
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    49.9
    (10.2)
    49.5
    (9.7)
    49.7
    (10.0)
    Sex: Female, Male (Count of Participants)
    Female
    135
    100%
    122
    100%
    257
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    Spain
    36
    26.7%
    29
    23.8%
    65
    25.3%
    Russian Federation
    14
    10.4%
    14
    11.5%
    28
    10.9%
    Germany
    74
    54.8%
    71
    58.2%
    145
    56.4%
    Italy
    11
    8.1%
    8
    6.6%
    19
    7.4%
    Eastern Cooperative Oncology Group Performance Status (participants) [Number]
    Grade 0 - Fully active
    131
    97%
    113
    92.6%
    244
    94.9%
    Grade 1- Ambulatory; strenuous activity restricted
    1
    0.7%
    4
    3.3%
    5
    1.9%
    Status Unknown
    3
    2.2%
    5
    4.1%
    8
    3.1%
    Estrogen and Progesterone Receptor Status (participants) [Number]
    At least one positive
    90
    66.7%
    78
    63.9%
    168
    65.4%
    Both negative
    45
    33.3%
    44
    36.1%
    89
    34.6%
    Menopausal Status (participants) [Number]
    Unknown
    0
    0%
    1
    0.8%
    1
    0.4%
    Pre-Menopausal
    69
    51.1%
    66
    54.1%
    135
    52.5%
    Peri-Menopausal
    6
    4.4%
    7
    5.7%
    13
    5.1%
    Post-Menopausal
    60
    44.4%
    48
    39.3%
    108
    42%
    Race/Ethnicity (participants) [Number]
    Caucasian
    135
    100%
    119
    97.5%
    254
    98.8%
    Hispanic
    0
    0%
    3
    2.5%
    3
    1.2%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With a Pathological Complete Response
    Description pathological assessment of tissue removed during surgery to determine if tumor tissue is still present after chemotherapy
    Time Frame surgery after eight 21-day cycles of chemotherapy

    Outcome Measure Data

    Analysis Population Description
    Participants meeting the following criteria qualify for pathological tumor response: Histologic diagnosis of primary operable breast cancer No concurrent antitumor therapy Specimen for evaluation of pathological response obtained upon surgery Treatment with at least one dose of study drug of the assigned study regimen.
    Arm/Group Title Pemetrexed Plus Doxorubicin, Followed by Docetaxel Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
    Arm/Group Description pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8) cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
    Measure Participants 127 119
    Pathological Complete Response
    21
    15.6%
    24
    19.7%
    Tumor Cells Still Present
    99
    73.3%
    89
    73%
    Not evaluable
    7
    5.2%
    6
    4.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pemetrexed Plus Doxorubicin, Followed by Docetaxel
    Comments Confidence Interval for pathological complete response in the Pemetrexed treatment arm.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage of Participants
    Estimated Value 16.5
    Confidence Interval () 95%
    10.5 to 24.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
    Comments Confidence Interval for pathological complete response in the Cyclophosphamide treatment group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage of Participants
    Estimated Value 20.2
    Confidence Interval () 95%
    13.4 to 28.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy
    Description The number of participants with a clinical tumor response based on measurement of tumor size after the first sequence of chemotherapy, without a second confirmatory tumor measurement, per protocol.
    Time Frame Cycles 1-4 (21-day cycles)

    Outcome Measure Data

    Analysis Population Description
    Participants meeting following criteria qualify for clinical tumor response: Histologic diagnosis of primary operable breast cancer No concurrent antitumor therapy up to surgery Presence of measurable disease as defined by RECIST. Treatment with at least one dose of study drug of assigned study regimen.
    Arm/Group Title Pemetrexed Plus Doxorubicin, Followed by Docetaxel Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
    Arm/Group Description pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8) cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
    Measure Participants 131 119
    Complete Response
    8
    5.9%
    9
    7.4%
    Partial Response
    45
    33.3%
    43
    35.2%
    Stable Disease
    49
    36.3%
    44
    36.1%
    Progressive Disease
    3
    2.2%
    2
    1.6%
    Unknown
    17
    12.6%
    17
    13.9%
    Not Done
    9
    6.7%
    4
    3.3%
    3. Secondary Outcome
    Title Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy
    Description The number of participants with a clinical tumor response based on measurement of tumor size after the second sequence of chemotherapy, without a second confirmatory tumor measurement required, per protocol.
    Time Frame Cycles 5-8 (21-day cycles)

    Outcome Measure Data

    Analysis Population Description
    Participants meeting following criteria qualify for clinical tumor response: Histologic diagnosis of primary operable breast cancer No concurrent antitumor therapy up to surgery Presence of measurable disease as defined by RECIST. Treatment with at least one dose of study drug of assigned study regimen.
    Arm/Group Title Pemetrexed Plus Doxorubicin, Followed by Docetaxel Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
    Arm/Group Description pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8) cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
    Measure Participants 131 119
    Complete Tumor Response
    19
    14.1%
    21
    17.2%
    Partial Tumor Response
    59
    43.7%
    60
    49.2%
    Stable Disease
    35
    25.9%
    24
    19.7%
    Progressive Disease
    2
    1.5%
    1
    0.8%
    Unknown
    9
    6.7%
    10
    8.2%
    Not Done
    7
    5.2%
    3
    2.5%
    4. Secondary Outcome
    Title Number of Patients With Histologically Negative Axillary Lymph Node Status at Surgery
    Description Histologically negative is defined as no malignant cells present in the axillary lymph nodes during surgery.
    Time Frame surgery after eight 21-day cycles of chemotherapy

    Outcome Measure Data

    Analysis Population Description
    Participants meeting the following criteria qualify for pathological tumor response: Histologic diagnosis of primary operable breast cancer No concurrent antitumor therapy Specimen for evaluation of pathological response obtained upon surgery Treatment with at least one dose of study drug of the assigned study regimen.
    Arm/Group Title Pemetrexed Plus Doxorubicin, Followed by Docetaxel Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
    Arm/Group Description pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8) cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
    Measure Participants 127 119
    Number [participants]
    64
    47.4%
    63
    51.6%
    5. Secondary Outcome
    Title Disease-free Survival
    Description Disease-free survival is defined as the time from date of study enrollment (randomization) to first date of progressive disease (PD) or death from any cause. PD per Response Evaluation Criteria In Solid Tumors (RECIST) criteria is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For patients not known to have died as of the data cut-off date and who do not have progressive disease, disease-free survival was censored at the last contact date.
    Time Frame baseline through post surgery, follow-up for 3 years post-surgery (up to 5.2 years after randomization)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. In the Pemetrexed plus Doxorubicin, Followed by Docetaxel arm, 99 participants were censored. In the Cyclophosphamide plus Doxorubicin, Followed by Docetaxel arm, 94 participants were censored.
    Arm/Group Title Pemetrexed Plus Doxorubicin, Followed by Docetaxel Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
    Arm/Group Description pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8) cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
    Measure Participants 135 122
    Median (95% Confidence Interval) [months]
    NA
    NA

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Pemetrexed Plus Doxorubicin, Followed by Docetaxel Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
    Arm/Group Description pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8) cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
    All Cause Mortality
    Pemetrexed Plus Doxorubicin, Followed by Docetaxel Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Pemetrexed Plus Doxorubicin, Followed by Docetaxel Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 15/134 (11.2%) 25/123 (20.3%)
    Blood and lymphatic system disorders
    Anaemia 0/134 (0%) 0 1/123 (0.8%) 1
    Chronic lymphocytic leukaemia 0/134 (0%) 0 1/123 (0.8%) 1
    Febrile neutropenia 4/134 (3%) 5 5/123 (4.1%) 6
    Leukopenia 4/134 (3%) 4 9/123 (7.3%) 9
    Neutropenia 1/134 (0.7%) 1 3/123 (2.4%) 3
    Cardiac disorders
    Cardiovascular insufficiency 0/134 (0%) 0 1/123 (0.8%) 1
    Myocardial infarction 0/134 (0%) 0 1/123 (0.8%) 1
    Gastrointestinal disorders
    Diarrhoea 1/134 (0.7%) 2 1/123 (0.8%) 1
    Nausea 2/134 (1.5%) 2 0/123 (0%) 0
    Stomatitis 1/134 (0.7%) 1 0/123 (0%) 0
    Vomiting 3/134 (2.2%) 4 0/123 (0%) 0
    General disorders
    Fatigue 0/134 (0%) 0 2/123 (1.6%) 2
    General physical health deterioration 0/134 (0%) 0 1/123 (0.8%) 1
    Inflammation 0/134 (0%) 0 1/123 (0.8%) 1
    Injection site extravasation 0/134 (0%) 0 1/123 (0.8%) 1
    Mucosal inflammation 0/134 (0%) 0 2/123 (1.6%) 2
    Pyrexia 3/134 (2.2%) 3 5/123 (4.1%) 5
    Hepatobiliary disorders
    Hepatic function abnormal 0/134 (0%) 0 1/123 (0.8%) 1
    Hyperbilirubinaemia 0/134 (0%) 0 1/123 (0.8%) 1
    Infections and infestations
    Appendicitis 0/134 (0%) 0 2/123 (1.6%) 2
    Febrile infection 1/134 (0.7%) 1 0/123 (0%) 0
    Infection 1/134 (0.7%) 1 0/123 (0%) 0
    Pharyngitis 1/134 (0.7%) 1 0/123 (0%) 0
    Pneumonia 1/134 (0.7%) 1 1/123 (0.8%) 1
    Pneumonia primary atypical 0/134 (0%) 0 1/123 (0.8%) 1
    Pyelonephritis 0/134 (0%) 0 1/123 (0.8%) 1
    Sinusitis 0/134 (0%) 0 1/123 (0.8%) 1
    Vulvitis 0/134 (0%) 0 1/123 (0.8%) 1
    Investigations
    C-reactive protein increased 0/134 (0%) 0 1/123 (0.8%) 1
    Musculoskeletal and connective tissue disorders
    Myalgia 1/134 (0.7%) 1 0/123 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to central nervous system 0/134 (0%) 0 1/123 (0.8%) 1
    Nervous system disorders
    Dizziness 0/134 (0%) 0 1/123 (0.8%) 1
    Syncope 0/134 (0%) 0 1/123 (0.8%) 1
    Vascular encephalopathy 0/134 (0%) 0 1/123 (0.8%) 1
    Psychiatric disorders
    Anxiety 0/134 (0%) 0 1/123 (0.8%) 1
    Major depression 0/134 (0%) 0 1/123 (0.8%) 1
    Mood altered 0/134 (0%) 0 1/123 (0.8%) 1
    Renal and urinary disorders
    Nephritis 1/134 (0.7%) 1 0/123 (0%) 0
    Vascular disorders
    Axillary vein thrombosis 0/134 (0%) 0 1/123 (0.8%) 1
    Hypotension 0/134 (0%) 0 1/123 (0.8%) 1
    Hypovolaemic shock 1/134 (0.7%) 1 0/123 (0%) 0
    Peripheral vascular disorder 1/134 (0.7%) 1 0/123 (0%) 0
    Post procedural haematoma 0/134 (0%) 0 1/123 (0.8%) 1
    Subclavian vein thrombosis 0/134 (0%) 0 1/123 (0.8%) 1
    Other (Not Including Serious) Adverse Events
    Pemetrexed Plus Doxorubicin, Followed by Docetaxel Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 134/134 (100%) 120/123 (97.6%)
    Blood and lymphatic system disorders
    Anaemia 10/134 (7.5%) 17 11/123 (8.9%) 19
    Leukocytosis 13/134 (9.7%) 29 9/123 (7.3%) 18
    Leukopenia 66/134 (49.3%) 229 67/123 (54.5%) 252
    Lymphopenia 19/134 (14.2%) 53 18/123 (14.6%) 50
    Neutropenia 65/134 (48.5%) 223 73/123 (59.3%) 244
    Neutrophilia 7/134 (5.2%) 14 4/123 (3.3%) 7
    Thrombocythaemia 9/134 (6.7%) 12 5/123 (4.1%) 5
    Thrombocytopenia 8/134 (6%) 18 12/123 (9.8%) 22
    Eye disorders
    Conjunctivitis 19/134 (14.2%) 32 10/123 (8.1%) 14
    Lacrimation increased 16/134 (11.9%) 20 14/123 (11.4%) 15
    Gastrointestinal disorders
    Abdominal pain 16/134 (11.9%) 18 12/123 (9.8%) 17
    Abdominal pain upper 21/134 (15.7%) 24 11/123 (8.9%) 12
    Constipation 49/134 (36.6%) 81 35/123 (28.5%) 51
    Diarrhoea 33/134 (24.6%) 50 27/123 (22%) 42
    Dyspepsia 10/134 (7.5%) 11 9/123 (7.3%) 9
    Nausea 82/134 (61.2%) 207 81/123 (65.9%) 210
    Stomatitis 53/134 (39.6%) 95 47/123 (38.2%) 90
    Vomiting 30/134 (22.4%) 43 40/123 (32.5%) 69
    General disorders
    Asthenia 34/134 (25.4%) 90 28/123 (22.8%) 75
    Chills 9/134 (6.7%) 9 11/123 (8.9%) 11
    Fatigue 49/134 (36.6%) 100 45/123 (36.6%) 106
    Mucosal inflammation 27/134 (20.1%) 47 18/123 (14.6%) 24
    Pain 8/134 (6%) 9 8/123 (6.5%) 8
    Pyrexia 21/134 (15.7%) 30 21/123 (17.1%) 28
    Infections and infestations
    Nasopharyngitis 6/134 (4.5%) 6 9/123 (7.3%) 9
    Investigations
    Alanine aminotransferase 22/134 (16.4%) 30 7/123 (5.7%) 10
    Alanine aminotransferase increased 57/134 (42.5%) 87 33/123 (26.8%) 40
    Aspartate aminotransferase 22/134 (16.4%) 29 7/123 (5.7%) 7
    Aspartate aminotransferase increased 54/134 (40.3%) 80 29/123 (23.6%) 32
    Blood alkaline phosphatase increased 5/134 (3.7%) 5 7/123 (5.7%) 11
    Blood glucose increased 11/134 (8.2%) 25 6/123 (4.9%) 13
    Blood lactate dehydrogenase increased 26/134 (19.4%) 33 15/123 (12.2%) 23
    Gamma-glutamyltransferase increased 8/134 (6%) 11 7/123 (5.7%) 8
    Haemoglobin 9/134 (6.7%) 11 6/123 (4.9%) 7
    Haemoglobin decreased 32/134 (23.9%) 83 38/123 (30.9%) 86
    Neutrophil count 9/134 (6.7%) 21 4/123 (3.3%) 9
    Neutrophil count decreased 15/134 (11.2%) 38 9/123 (7.3%) 21
    Neutrophil count increased 10/134 (7.5%) 22 12/123 (9.8%) 23
    Platelet count increased 8/134 (6%) 11 5/123 (4.1%) 6
    Red blood cell count decreased 7/134 (5.2%) 9 4/123 (3.3%) 7
    White blood cell count 10/134 (7.5%) 18 6/123 (4.9%) 15
    White blood cell count decreased 13/134 (9.7%) 28 8/123 (6.5%) 19
    White blood cell count increased 12/134 (9%) 23 12/123 (9.8%) 22
    Metabolism and nutrition disorders
    Anorexia 22/134 (16.4%) 34 25/123 (20.3%) 47
    Fluid retention 20/134 (14.9%) 23 14/123 (11.4%) 16
    Hyperglycaemia 12/134 (9%) 21 8/123 (6.5%) 10
    Musculoskeletal and connective tissue disorders
    Arthralgia 26/134 (19.4%) 56 28/123 (22.8%) 59
    Bone pain 16/134 (11.9%) 16 16/123 (13%) 21
    Musculoskeletal pain 8/134 (6%) 14 10/123 (8.1%) 15
    Myalgia 19/134 (14.2%) 23 21/123 (17.1%) 30
    Nervous system disorders
    Dizziness 6/134 (4.5%) 9 8/123 (6.5%) 9
    Dysgeusia 20/134 (14.9%) 27 26/123 (21.1%) 37
    Headache 12/134 (9%) 14 20/123 (16.3%) 26
    Peripheral sensory neuropathy 15/134 (11.2%) 25 12/123 (9.8%) 18
    Polyneuropathy 25/134 (18.7%) 32 24/123 (19.5%) 31
    Psychiatric disorders
    Insomnia 7/134 (5.2%) 9 3/123 (2.4%) 4
    Respiratory, thoracic and mediastinal disorders
    Cough 7/134 (5.2%) 10 12/123 (9.8%) 14
    Dyspnoea 5/134 (3.7%) 5 8/123 (6.5%) 9
    Skin and subcutaneous tissue disorders
    Alopecia 80/134 (59.7%) 88 68/123 (55.3%) 75
    Dry skin 7/134 (5.2%) 8 9/123 (7.3%) 10
    Erythema 19/134 (14.2%) 31 17/123 (13.8%) 29
    Nail disorder 38/134 (28.4%) 47 35/123 (28.5%) 45
    Palmar-plantar erythrodysaesthesia syndrome 14/134 (10.4%) 17 13/123 (10.6%) 14
    Pruritus 11/134 (8.2%) 11 14/123 (11.4%) 16
    Rash 14/134 (10.4%) 14 4/123 (3.3%) 6
    Vascular disorders
    Hot flush 6/134 (4.5%) 7 12/123 (9.8%) 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:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT00149214
    Other Study ID Numbers:
    • 7113
    • H3E-MC-S080
    First Posted:
    Sep 8, 2005
    Last Update Posted:
    Mar 21, 2012
    Last Verified:
    Mar 1, 2012