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Chemotherapy for Patients With Non-Small Cell Lung Cancer Who Are Non-Smokers

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00409006
Collaborator
(none)
70
Enrollment
7
Locations
2
Arms
38.9
Duration (Months)
10
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the efficacy and safety of chemotherapy followed sequentially by gefitinib versus chemotherapy alone in the first line treatment of non-small cell lung cancer (NSCLC). This study will be conducted in Asian patients who are classified as 'never smoker' since it is suggested that these patients are more likely to respond favorably to treatment with gefitinib.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Trial of Pemetrexed and Cisplatin Followed Sequentially by Gefitinib Versus Pemetrexed and Cisplatin in Asian "Never Smoker" Patients With Advanced Non-Small Cell Lung Cancer
Study Start Date :
Feb 1, 2007
Actual Primary Completion Date :
Aug 1, 2009
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pemetrexed/Cisplatin/Gefitinib

Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.

Drug: Pemetrexed
500 milligrams per meter squared (mg/m2), administered by intravenous (IV) infusion every 21 days for 4 cycles (1-4) or 500 mg/m2, IV, every 21 days until disease progression or unacceptable toxicity.
Other Names:
  • LY231514
  • Alimta

    • Drug: Cisplatin
    75 mg/m2, IV, every 21 days for 4 cycles (1-4) or 75 mg/m2, IV, every 21 days for 4 cycles with optional continuation for 2 additional cycles until disease progression or unacceptable toxicity

    Drug: Gefitinib
    250 mg, administered orally once daily beginning at Cycle 5 until disease progression or unacceptable toxicity
    Experimental: Pemetrexed/Cisplatin

    Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.

    Drug: Pemetrexed
    500 milligrams per meter squared (mg/m2), administered by intravenous (IV) infusion every 21 days for 4 cycles (1-4) or 500 mg/m2, IV, every 21 days until disease progression or unacceptable toxicity.
    Other Names:
  • LY231514
  • Alimta

    • Drug: Cisplatin
    75 mg/m2, IV, every 21 days for 4 cycles (1-4) or 75 mg/m2, IV, every 21 days for 4 cycles with optional continuation for 2 additional cycles until disease progression or unacceptable toxicity

    Outcome Measures

    Primary Outcome Measures

    1. Progression-Free Survival (PFS) [Baseline to first observation of disease progression or death, 12 weeks up to 31 months]

      Defined as the time from randomization to the first observation of disease progression, or death due to any cause.

    Secondary Outcome Measures

    1. Number of Participants With Tumor Response [Baseline to measured response or death, 12 weeks up to 31 months]

      Response 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 not meeting above criteria. Responder is a participant exhibiting a best overall study response of CR or PR.

    2. Duration of Response for Responders [Time of response to progressive disease or death, 12 weeks up to 31 months]

      The duration of a complete response (CR; the disappearance of all target lesions) or partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. A responder is a patient exhibiting a best overall study response of CR or PR.

    3. Overall Survival [Baseline to date of death from any cause, 12 weeks up to 31 months]

      Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. Median overall survival could not be estimated as most participants were living at the end of the study. 25 participants from each treatment group were censored. In place of this outcome measure, the percentage of participants who died during the study are provided in the Post-Hoc Analysis Outcome Measure: Percentage of Participants Who Died During the Study.

    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 diagnosis non-small cell lung cancer (NSCLC) (Stage IIIB or IV)

    • Have not received any prior chemotherapy, molecular therapy, immunotherapy, biological therapy, or radiotherapy. Exception: palliative radiotherapy that is completed at least 4 weeks prior to study enrolment.

    • Have 'never smoked' (defined as having smoked <100 cigarettes during his/her lifetime)

    • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

    Exclusion Criteria:

    • Concurrent administration of any other tumor therapy

    • Other co-existing malignancies

    • Pregnancy or breast feeding

    • Serious concomitant disorders

    • Inability or unwillingness to take folic acid or vitamin B12 supplementation

    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. Fujian China 350014
    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. Qingdao China 266003
    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. Shanghai China 201900
    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. Seoul Korea, Republic of 137-701
    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. Changhua Taiwan 500
    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. Taipei Taiwan 100
    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. Tao-Yuan Taiwan 333

    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:
    NCT00409006
    Other Study ID Numbers:
    • 10918
    • H3E-AA-S110
    First Posted:
    Dec 8, 2006
    Last Update Posted:
    Sep 9, 2010
    Last Verified:
    Aug 1, 2010
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Pemetrexed
    Gefitinib

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 86 participants entered study. 13 participants were screen failures. 73 participants (40 pemetrexed/cisplatin/gefitinib and 33 pemetrexed/cisplatin) were assigned to treatment. 3 participants did not receive study drug. These 16 participants (13 screen failures and 3 that did not receive drug) were not included in the analyses.
    Arm/Group Title Pemetrexed/Cisplatin/Gefitinib Pemetrexed/Cisplatin
    Arm/Group Description Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity. Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
    Period Title: Overall Study
    STARTED 39 31
    COMPLETED 19 19
    NOT COMPLETED 20 12

    Baseline Characteristics

    Arm/Group Title Pemetrexed/Cisplatin/Gefitinib Pemetrexed/Cisplatin Total
    Arm/Group Description Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity. Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity. Total of all reporting groups
    Overall Participants 39 31 70
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    55.6
    (8.45)
    55.7
    (12.43)
    55.7
    (10.32)
    Sex: Female, Male (Count of Participants)
    Female
    30
    76.9%
    25
    80.6%
    55
    78.6%
    Male
    9
    23.1%
    6
    19.4%
    15
    21.4%
    Race/Ethnicity, Customized (Number) [Number]
    East Asian
    39
    100%
    31
    100%
    70
    100%
    Region of Enrollment (participants) [Number]
    Taiwan
    10
    25.6%
    11
    35.5%
    21
    30%
    China
    16
    41%
    14
    45.2%
    30
    42.9%
    Korea, Republic of
    13
    33.3%
    6
    19.4%
    19
    27.1%
    Eastern Cooperative Oncology Group (ECOG) Performance Status (Units on a scale) [Number]
    0
    15
    9
    24
    1
    24
    22
    46
    History of Smoking (Number) [Number]
    Yes
    0
    0%
    2
    6.5%
    2
    2.9%
    No
    39
    100%
    29
    93.5%
    68
    97.1%
    Basis of Diagnosis (Number) [Number]
    Histopathological
    30
    76.9%
    22
    71%
    52
    74.3%
    Cytological
    9
    23.1%
    9
    29%
    18
    25.7%
    Pathological Diagnosis (Number) [Number]
    Mixed Cell Carcinoma, Lung
    1
    2.6%
    1
    3.2%
    2
    2.9%
    Adenocarcinoma
    30
    76.9%
    24
    77.4%
    54
    77.1%
    Carcinoma, Squamous Cell
    7
    17.9%
    4
    12.9%
    11
    15.7%
    Non-Small Cell Lung Carcinoma
    1
    2.6%
    2
    6.5%
    3
    4.3%
    Disease Stage (Number) [Number]
    Stage IIIB
    6
    15.4%
    4
    12.9%
    10
    14.3%
    Stage IV
    33
    84.6%
    27
    87.1%
    60
    85.7%

    Outcome Measures

    1. Primary Outcome
    Title Progression-Free Survival (PFS)
    Description Defined as the time from randomization to the first observation of disease progression, or death due to any cause.
    Time Frame Baseline to first observation of disease progression or death, 12 weeks up to 31 months

    Outcome Measure Data

    Analysis Population Description
    Randomized and treated (RT) population includes all randomized patients. Patients are analyzed according to the treatment they actually received (intent-to-treat [ITT] analysis). Patients were censored from this analysis (8 pemetrexed/cisplatin/gefitinib and 11 pemetrexed/cisplatin).
    Arm/Group Title Pemetrexed/Cisplatin/Gefitinib Pemetrexed/Cisplatin
    Arm/Group Description Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity. Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
    Measure Participants 39 31
    Median (95% Confidence Interval) [Months]
    9.95
    6.83
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pemetrexed/Cisplatin/Gefitinib, Pemetrexed/Cisplatin
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0618
    Comments
    Method Log Rank
    Comments
    2. Secondary Outcome
    Title Number of Participants With Tumor Response
    Description Response 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 not meeting above criteria. Responder is a participant exhibiting a best overall study response of CR or PR.
    Time Frame Baseline to measured response or death, 12 weeks up to 31 months

    Outcome Measure Data

    Analysis Population Description
    Qualified for Response population includes all treated patients with measurable disease prior first dose of study therapy.
    Arm/Group Title Pemetrexed/Cisplatin/Gefitinib Pemetrexed/Cisplatin
    Arm/Group Description Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity. Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
    Measure Participants 39 31
    Number [Participants]
    18
    46.2%
    11
    35.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pemetrexed/Cisplatin/Gefitinib, Pemetrexed/Cisplatin
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.369
    Comments
    Method Regression, Logistic
    Comments Used the Wald Chi-squared statistic from a logistic regression analysis.
    3. Secondary Outcome
    Title Duration of Response for Responders
    Description The duration of a complete response (CR; the disappearance of all target lesions) or partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. A responder is a patient exhibiting a best overall study response of CR or PR.
    Time Frame Time of response to progressive disease or death, 12 weeks up to 31 months

    Outcome Measure Data

    Analysis Population Description
    Qualified for Response population includes all treated patients with measurable disease prior first dose of study therapy. Patients were censored for this analysis (2 pemetrexed/cisplatin/gefitinib and 2 pemetrexed/cisplatin).
    Arm/Group Title Pemetrexed/Cisplatin/Gefitinib Pemetrexed/Cisplatin
    Arm/Group Description Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity. Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
    Measure Participants 18 11
    Median (95% Confidence Interval) [Months]
    12.29
    4.14
    4. Post-Hoc Outcome
    Title Percentage of Participants Who Died During the Study
    Description This outcome measure takes the place of the outcome measure for Overall Survival, which could not be reported since the median value could not be calculated.
    Time Frame Baseline up to 31 months

    Outcome Measure Data

    Analysis Population Description
    Randomized and treated population includes all randomized patients. Patients are analyzed according to the treatment they actually received (ITT population). 25 participants from each treatment group were censored.
    Arm/Group Title Pemetrexed/Cisplatin/Gefitinib Pemetrexed/Cisplatin
    Arm/Group Description Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity. Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
    Measure Participants 39 31
    Number [Percentage of Participants]
    35.9
    92.1%
    19.4
    62.6%
    5. Secondary Outcome
    Title Overall Survival
    Description Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. Median overall survival could not be estimated as most participants were living at the end of the study. 25 participants from each treatment group were censored. In place of this outcome measure, the percentage of participants who died during the study are provided in the Post-Hoc Analysis Outcome Measure: Percentage of Participants Who Died During the Study.
    Time Frame Baseline to date of death from any cause, 12 weeks up to 31 months

    Outcome Measure Data

    Analysis Population Description
    Randomized and treated population includes all randomized patients. Patients are analyzed according to the treatment they actually received (ITT population). Median overall survival could not be estimated as most participants were living at the end of the study.
    Arm/Group Title Pemetrexed/Cisplatin/Gefitinib Pemetrexed/Cisplatin
    Arm/Group Description Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity. Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
    Measure Participants 0 0

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Pemetrexed/Cisplatin/Gefitinib Pemetrexed/Cisplatin
    Arm/Group Description Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity. Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
    All Cause Mortality
    Pemetrexed/Cisplatin/Gefitinib Pemetrexed/Cisplatin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Pemetrexed/Cisplatin/Gefitinib Pemetrexed/Cisplatin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 6/39 (15.4%) 3/31 (9.7%)
    Gastrointestinal disorders
    Nausea 1/39 (2.6%) 1 1/31 (3.2%) 1
    Vomiting 1/39 (2.6%) 2 1/31 (3.2%) 1
    General disorders
    Death 1/39 (2.6%) 1 0/31 (0%) 0
    Pyrexia 1/39 (2.6%) 1 0/31 (0%) 0
    Infections and infestations
    Acute tonsillitis 1/39 (2.6%) 1 0/31 (0%) 0
    Infection 0/39 (0%) 0 1/31 (3.2%) 1
    Metabolism and nutrition disorders
    Anorexia 1/39 (2.6%) 1 0/31 (0%) 0
    Musculoskeletal and connective tissue disorders
    Myalgia 1/39 (2.6%) 1 0/31 (0%) 0
    Nervous system disorders
    Coma 1/39 (2.6%) 1 0/31 (0%) 0
    Headache 1/39 (2.6%) 2 1/31 (3.2%) 1
    Psychiatric disorders
    Depressed mood 1/39 (2.6%) 1 0/31 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Apnoeic attack 1/39 (2.6%) 1 0/31 (0%) 0
    Asthma 0/39 (0%) 0 1/31 (3.2%) 1
    Cough 1/39 (2.6%) 1 0/31 (0%) 0
    Oropharyngeal pain 1/39 (2.6%) 1 0/31 (0%) 0
    Pleural effusion 1/39 (2.6%) 1 0/31 (0%) 0
    Pneumonitis 0/39 (0%) 0 1/31 (3.2%) 1
    Productive cough 1/39 (2.6%) 1 0/31 (0%) 0
    Other (Not Including Serious) Adverse Events
    Pemetrexed/Cisplatin/Gefitinib Pemetrexed/Cisplatin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 38/39 (97.4%) 31/31 (100%)
    Blood and lymphatic system disorders
    Anaemia 2/39 (5.1%) 2 0/31 (0%) 0
    Neutropenia 5/39 (12.8%) 12 3/31 (9.7%) 5
    Eye disorders
    Dry eye 2/39 (5.1%) 2 0/31 (0%) 0
    Vision blurred 2/39 (5.1%) 2 1/31 (3.2%) 1
    Gastrointestinal disorders
    Abdominal discomfort 1/39 (2.6%) 1 2/31 (6.5%) 2
    Abdominal distension 3/39 (7.7%) 3 0/31 (0%) 0
    Abdominal pain 2/39 (5.1%) 3 2/31 (6.5%) 2
    Abdominal pain upper 2/39 (5.1%) 2 3/31 (9.7%) 3
    Constipation 7/39 (17.9%) 12 5/31 (16.1%) 7
    Diarrhoea 10/39 (25.6%) 14 3/31 (9.7%) 5
    Dyspepsia 6/39 (15.4%) 7 2/31 (6.5%) 2
    Nausea 27/39 (69.2%) 63 20/31 (64.5%) 45
    Stomatitis 8/39 (20.5%) 13 1/31 (3.2%) 1
    Toothache 5/39 (12.8%) 5 0/31 (0%) 0
    Vomiting 19/39 (48.7%) 52 15/31 (48.4%) 29
    General disorders
    Asthenia 3/39 (7.7%) 5 1/31 (3.2%) 1
    Chest discomfort 1/39 (2.6%) 2 2/31 (6.5%) 2
    Chest pain 4/39 (10.3%) 4 3/31 (9.7%) 7
    Fatigue 10/39 (25.6%) 20 5/31 (16.1%) 9
    Malaise 2/39 (5.1%) 2 0/31 (0%) 0
    Mucosal inflammation 2/39 (5.1%) 3 3/31 (9.7%) 3
    Oedema peripheral 2/39 (5.1%) 2 1/31 (3.2%) 1
    Pyrexia 4/39 (10.3%) 4 1/31 (3.2%) 1
    Infections and infestations
    Cystitis 2/39 (5.1%) 2 0/31 (0%) 0
    Empyema 2/39 (5.1%) 2 0/31 (0%) 0
    Paronychia 4/39 (10.3%) 5 0/31 (0%) 0
    Rhinitis 4/39 (10.3%) 6 0/31 (0%) 0
    Upper respiratory tract infection 3/39 (7.7%) 4 0/31 (0%) 0
    Investigations
    Alanine aminotransferase increased 5/39 (12.8%) 6 6/31 (19.4%) 11
    Aspartate aminotransferase increased 5/39 (12.8%) 6 6/31 (19.4%) 7
    Creatinine renal clearance decreased 3/39 (7.7%) 3 4/31 (12.9%) 8
    Haemoglobin decreased 8/39 (20.5%) 8 11/31 (35.5%) 12
    Neutrophil count decreased 8/39 (20.5%) 14 13/31 (41.9%) 26
    Weight decreased 2/39 (5.1%) 2 0/31 (0%) 0
    White blood cell count decreased 6/39 (15.4%) 9 8/31 (25.8%) 14
    Metabolism and nutrition disorders
    Anorexia 19/39 (48.7%) 35 15/31 (48.4%) 24
    Decreased appetite 0/39 (0%) 0 2/31 (6.5%) 2
    Hyperglycaemia 2/39 (5.1%) 2 1/31 (3.2%) 1
    Hyperkalaemia 0/39 (0%) 0 2/31 (6.5%) 3
    Hypokalaemia 2/39 (5.1%) 3 0/31 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back pain 7/39 (17.9%) 8 1/31 (3.2%) 1
    Bone pain 2/39 (5.1%) 2 2/31 (6.5%) 2
    Musculoskeletal chest pain 3/39 (7.7%) 3 1/31 (3.2%) 2
    Neck pain 2/39 (5.1%) 2 1/31 (3.2%) 1
    Pain in extremity 3/39 (7.7%) 4 1/31 (3.2%) 2
    Nervous system disorders
    Dizziness 6/39 (15.4%) 8 3/31 (9.7%) 4
    Headache 4/39 (10.3%) 6 1/31 (3.2%) 1
    Hypoaesthesia 1/39 (2.6%) 1 3/31 (9.7%) 3
    Peripheral sensory neuropathy 6/39 (15.4%) 8 2/31 (6.5%) 2
    Psychiatric disorders
    Anxiety 2/39 (5.1%) 2 1/31 (3.2%) 1
    Depression 2/39 (5.1%) 3 0/31 (0%) 0
    Insomnia 9/39 (23.1%) 12 4/31 (12.9%) 7
    Renal and urinary disorders
    Pollakiuria 2/39 (5.1%) 2 0/31 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 9/39 (23.1%) 11 4/31 (12.9%) 4
    Dyspnoea 6/39 (15.4%) 8 8/31 (25.8%) 8
    Oropharyngeal pain 3/39 (7.7%) 3 1/31 (3.2%) 1
    Productive cough 3/39 (7.7%) 4 1/31 (3.2%) 1
    Pulmonary haemorrhage 2/39 (5.1%) 2 0/31 (0%) 0
    Rhinitis allergic 2/39 (5.1%) 2 0/31 (0%) 0
    Skin and subcutaneous tissue disorders
    Alopecia 1/39 (2.6%) 2 3/31 (9.7%) 3
    Dermatitis acneiform 3/39 (7.7%) 3 0/31 (0%) 0
    Dry skin 6/39 (15.4%) 6 0/31 (0%) 0
    Exfoliative rash 2/39 (5.1%) 2 1/31 (3.2%) 1
    Nail disorder 2/39 (5.1%) 2 0/31 (0%) 0
    Palmar-plantar erythrodysaesthesia syndrome 2/39 (5.1%) 2 0/31 (0%) 0
    Pruritus 14/39 (35.9%) 29 5/31 (16.1%) 6
    Rash 13/39 (33.3%) 21 6/31 (19.4%) 6
    Skin exfoliation 4/39 (10.3%) 4 0/31 (0%) 0
    Skin hyperpigmentation 2/39 (5.1%) 2 0/31 (0%) 0

    Limitations/Caveats

    Median overall survival cannot be estimated due to the high censor rate (25 participants per treatment group were censored). Most participants were still living at the end of the study.

    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 800-545-5979
    Email
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00409006
    Other Study ID Numbers:
    • 10918
    • H3E-AA-S110
    First Posted:
    Dec 8, 2006
    Last Update Posted:
    Sep 9, 2010
    Last Verified:
    Aug 1, 2010