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Chemotherapy With Pemetrexed in Combination With Platinum for Advanced Non-Small Cell Lung Cancer (NSCLC)

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00402051
Collaborator
(none)
133
Enrollment
12
Locations
2
Arms
30
Duration (Months)
11.1
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a two-arm, parallel, open-label, Phase 2 multicenter study of pemetrexed as first line combination therapy with either cisplatin or carboplatin in the palliative setting of stage IIIb and IV non-small cell lung cancer patients. Approximately 130 patients will be included in about 15 centers in Germany and randomized to one of the above treatment regimens in a 1:1 ratio. Chemotherapy will be administered over a maximum of six cycles with a standard length of 21 days. Primary objective will be the Progression Free Survival Time of patients as assessed in both treatment arms.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
133 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase 2 Study of Pemetrexed in Combination With Cisplatin or Carboplatin in the First Line Therapy of Advanced NSCLC
Study Start Date :
Nov 1, 2006
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
May 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pemetrexed + Cisplatin

Drug: Pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 6 cycles
Other Names:
  • LY231514
  • Alimta

    • Drug: Cisplatin
    75 mg/m2, intravenous (IV), every 21 days x 6 cycles
    Experimental: Pemetrexed + Carboplatin

    Drug: Pemetrexed
    500 mg/m2, intravenous (IV), every 21 days x 6 cycles
    Other Names:
  • LY231514
  • Alimta

    • Drug: Carboplatin
    Area under the concentration curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Surviving Progression-Free at 6 Months (Progression Free Survival [PFS] Rate) [Randomization to Month 6]

      For this study, we used the exponential distribution (assumption done for the calculation of the sample size) to estimate the PFS rate. The PFS rate (%) and the 95% confidence intervals were calculated based on the following formula: exp(-6 λ) ± 1.96 * exp(-6 λ) * (-6 λ)/√r. Where λ was calculated based on the Maximum-Likelihood estimator for ln(λ) as given by (Collett 2003): ln(λ) = ln[ r / ∑ti ] with r = number of patients with events up to 6 months, ti = survival time of patient i (i=1,…,n), event or censored up to 6 months, and n= total number of patients per treatment group.

    Secondary Outcome Measures

    1. Overall Survival [Randomization to date of death from any cause (up to 1 year)]

      Defined as the time from randomization to the date of death from any cause.

    2. Number of Participants With Tumor Response (as Basis for Response Rate) [Every 6 weeks for 6 months during the treatment period, and every 3 months during the follow-up period, until disease progression]

      Best overall response was evaluated using RECIST Criteria which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatment. CR: complete response, disappearance of all target lesions; PR: partial response, 30% decrease in sum of the longest diameter of target lesions; PD: progressive disease, 20% increase in sum of the longest diameter of target lesions; SD: stable disease, small changes not meeting above criteria. Response Rate: number of participants with response(CR+PR)per total population, multiplied by 100 to give a percentage.

    3. Time to Treatment Failure (TTF) [Randomization to stopping of treatment, progression, death or initiation of further chemotherapy, whichever occurs first (up to 1 year)]

      Defined as time from randomization to the first date of disease progression, death due to any cause, or early discontinuation of treatment (any reason), whichever occurred first

    4. Pharmacology Toxicities [Every 21-day cycle for up to 6 cycles]

      Number of patients experiencing Grade 3 or 4 hematologic and non-hematologic adverse events (AEs) possibly related to study drug or protocol procedures in this study (a subset of those listed in the AE Module). AEs were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). Grade 3 AEs are severe and undesirable; Grade 4 AEs are life-threatening or disabling.

    Eligibility Criteria

    Criteria

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

    • Cytologically and/or histologically confirmed NSCLC Stage IIIb or IV

    • No previous systemic chemotherapy for this cancer

    • At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria In Solid Tumors (RECIST) criteria

    • Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 and adequate organ function

    • Prior radiation therapy allowed but limited to <25% of the patient's bone marrow

    Exclusion Criteria:

    • Serious concomitant systemic disorder or active infection

    • Mild to moderate renal insufficiency, but unable to interrupt salicylates or other nonsteroidal anti-inflammatory drugs

    • Symptomatic central nervous system (CNS) metastases requiring concurrent corticosteroid therapy

    • Presence of clinically significant third-space fluid collections

    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. Coswig Germany D-01640
    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. Frankfurt Germany 65929
    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. Großhansdorf Germany D-22927
    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. Halle Germany D-06120
    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. Hamburg Germany D-21075
    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. Hofheim Germany D-65719
    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. Homburg/Saar Germany 66421
    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. Immenhausen Germany D-34376
    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. Leipzig Germany 04207
    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. Luebeck Germany 23538
    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. Mainz Germany 55131
    12 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. Muenchen Germany 81664

    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:
    NCT00402051
    Other Study ID Numbers:
    • 11077
    • H3E-SB-S109
    First Posted:
    Nov 22, 2006
    Last Update Posted:
    Feb 17, 2010
    Last Verified:
    Feb 1, 2010
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Carboplatin
    Pemetrexed

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 136 patients signed informed consent. Of these, 3 patients were discontinued prior to randomization (1x protocol entry criteria not met, 2x patient decision); 133 patients were randomized, 130 patients started study drug.
    Arm/Group Title Pemetrexed + Cisplatin Pemetrexed + Carboplatin
    Arm/Group Description Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
    Period Title: Overall Study
    STARTED 66 67
    Received Treatment 65 65
    COMPLETED 28 32
    NOT COMPLETED 38 35

    Baseline Characteristics

    Arm/Group Title Pemetrexed + Cisplatin Pemetrexed + Carboplatin Total
    Arm/Group Description Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles Total of all reporting groups
    Overall Participants 65 65 130
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    62.3
    (8.43)
    62.4
    (7.51)
    62.4
    (7.95)
    Sex: Female, Male (Count of Participants)
    Female
    23
    35.4%
    19
    29.2%
    42
    32.3%
    Male
    42
    64.6%
    46
    70.8%
    88
    67.7%
    Race/Ethnicity, Customized (participants) [Number]
    Caucasian
    65
    100%
    65
    100%
    130
    100%
    Region of Enrollment (participants) [Number]
    Germany
    65
    100%
    65
    100%
    130
    100%
    Eastern Cooperative Oncology Group (ECOG) Performance Status (participants) [Number]
    0 - Fully Active
    40
    61.5%
    45
    69.2%
    85
    65.4%
    1 - Ambulatory, Restricted Strenuous Activity
    25
    38.5%
    20
    30.8%
    45
    34.6%
    Histopathology (participants) [Number]
    Squamous Cell Carcinoma
    12
    18.5%
    13
    20%
    25
    19.2%
    Adenocarcinoma
    38
    58.5%
    44
    67.7%
    82
    63.1%
    Large Cell Carcinoma
    6
    9.2%
    3
    4.6%
    9
    6.9%
    Mixed Cell Carcinoma
    0
    0%
    1
    1.5%
    1
    0.8%
    Bronchioalveolar Carcinoma
    0
    0%
    1
    1.5%
    1
    0.8%
    NSCLC, Not Otherwise Specified
    9
    13.8%
    3
    4.6%
    12
    9.2%
    Presence of Bone and Brain Metastases (participants) [Number]
    Bone Metastases
    14
    21.5%
    11
    16.9%
    25
    19.2%
    Brain Metastases
    2
    3.1%
    1
    1.5%
    3
    2.3%
    Smoking Status (participants) [Number]
    Never Smoked
    9
    13.8%
    7
    10.8%
    16
    12.3%
    Past Smoker
    41
    63.1%
    42
    64.6%
    83
    63.8%
    Current Smoker
    15
    23.1%
    16
    24.6%
    31
    23.8%
    Stage of disease (participants) [Number]
    Stage IIIb (locally advanced disease)
    5
    7.7%
    9
    13.8%
    14
    10.8%
    Stage IV (metastatic disease)
    61
    93.8%
    58
    89.2%
    119
    91.5%
    Time Since Patient Stopped Smoking (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    10.1
    (12.31)
    7.4
    (10.56)
    8.7
    (11.46)
    Use of Tobacco Products (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    31.7
    (12.74)
    34.6
    (11.47)
    33.2
    (12.15)

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Surviving Progression-Free at 6 Months (Progression Free Survival [PFS] Rate)
    Description For this study, we used the exponential distribution (assumption done for the calculation of the sample size) to estimate the PFS rate. The PFS rate (%) and the 95% confidence intervals were calculated based on the following formula: exp(-6 λ) ± 1.96 * exp(-6 λ) * (-6 λ)/√r. Where λ was calculated based on the Maximum-Likelihood estimator for ln(λ) as given by (Collett 2003): ln(λ) = ln[ r / ∑ti ] with r = number of patients with events up to 6 months, ti = survival time of patient i (i=1,…,n), event or censored up to 6 months, and n= total number of patients per treatment group.
    Time Frame Randomization to Month 6

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set: All patients randomized who received at least one dose of study drug
    Arm/Group Title Pemetrexed + Cisplatin Pemetrexed + Carboplatin
    Arm/Group Description Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
    Measure Participants 65 65
    Number [percentage]
    52.8
    39.3
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pemetrexed + Cisplatin
    Comments Hypothesis testing was done independently for each treatment arm (no direct treatment group comparison).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter 6-Month PFS Rate
    Estimated Value 52.8
    Confidence Interval (2-Sided) 95%
    40.3 to 65.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Pemetrexed + Carboplatin
    Comments Hypothesis testing was done independently for each treatment arm (no direct treatment group comparison).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter 6-Month PFS Rate
    Estimated Value 39.3
    Confidence Interval (2-Sided) 95%
    27.8 to 50.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Overall Survival
    Description Defined as the time from randomization to the date of death from any cause.
    Time Frame Randomization to date of death from any cause (up to 1 year)

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set: All patients randomized who received at least one dose of study drug
    Arm/Group Title Pemetrexed + Cisplatin Pemetrexed + Carboplatin
    Arm/Group Description Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
    Measure Participants 65 65
    Median (95% Confidence Interval) [months]
    11.7
    8.9
    3. Secondary Outcome
    Title Number of Participants With Tumor Response (as Basis for Response Rate)
    Description Best overall response was evaluated using RECIST Criteria which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatment. CR: complete response, disappearance of all target lesions; PR: partial response, 30% decrease in sum of the longest diameter of target lesions; PD: progressive disease, 20% increase in sum of the longest diameter of target lesions; SD: stable disease, small changes not meeting above criteria. Response Rate: number of participants with response(CR+PR)per total population, multiplied by 100 to give a percentage.
    Time Frame Every 6 weeks for 6 months during the treatment period, and every 3 months during the follow-up period, until disease progression

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set: All patients randomized who received at least one dose of study drug
    Arm/Group Title Pemetrexed + Cisplatin Pemetrexed + Carboplatin
    Arm/Group Description Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
    Measure Participants 65 65
    Partial Response
    21
    32.3%
    13
    20%
    Stable Disease
    31
    47.7%
    32
    49.2%
    Disease Progression
    7
    10.8%
    15
    23.1%
    Unknown/Not Done
    6
    9.2%
    5
    7.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pemetrexed + Cisplatin
    Comments Response rates were evaluated separately for each treatment arm
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Best Overall Response Rate (%)
    Estimated Value 32.3
    Confidence Interval () 95%
    21.2 to 45.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Pemetrexed + Carboplatin
    Comments Response rates were evaluated separately for each treatment arm
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Best Overall Response Rate (%)
    Estimated Value 20.0
    Confidence Interval () 95%
    11.1 to 31.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Time to Treatment Failure (TTF)
    Description Defined as time from randomization to the first date of disease progression, death due to any cause, or early discontinuation of treatment (any reason), whichever occurred first
    Time Frame Randomization to stopping of treatment, progression, death or initiation of further chemotherapy, whichever occurs first (up to 1 year)

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set: All patients randomized who received at least one dose of study drug
    Arm/Group Title Pemetrexed + Cisplatin Pemetrexed + Carboplatin
    Arm/Group Description Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
    Measure Participants 65 65
    Median (95% Confidence Interval) [months]
    3.0
    3.4
    5. Secondary Outcome
    Title Pharmacology Toxicities
    Description Number of patients experiencing Grade 3 or 4 hematologic and non-hematologic adverse events (AEs) possibly related to study drug or protocol procedures in this study (a subset of those listed in the AE Module). AEs were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). Grade 3 AEs are severe and undesirable; Grade 4 AEs are life-threatening or disabling.
    Time Frame Every 21-day cycle for up to 6 cycles

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set: All patients randomized who received at least one dose of study drug
    Arm/Group Title Pemetrexed + Cisplatin Pemetrexed + Carboplatin
    Arm/Group Description Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
    Measure Participants 65 65
    Any Grade 3/4 Toxicity
    29
    44.6%
    36
    55.4%
    Grade 3/4 Leucopenia
    8
    12.3%
    12
    18.5%
    Grade 3/4 Neutropenia
    11
    16.9%
    17
    26.2%
    Grade 3/4 Anemia
    5
    7.7%
    7
    10.8%
    Grade 3/4 Thrombocytopenia
    2
    3.1%
    11
    16.9%
    Grade 3/4 Nausea
    3
    4.6%
    5
    7.7%
    Grade 3/4 Vomiting
    2
    3.1%
    1
    1.5%
    Grade 3/4 Fatigue
    2
    3.1%
    2
    3.1%
    Grade 3/4 Anorexia
    1
    1.5%
    2
    3.1%
    Grade 3/4 Urinary Tract Infection
    0
    0%
    2
    3.1%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Pemetrexed + Cisplatin Pemetrexed + Carboplatin
    Arm/Group Description Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
    All Cause Mortality
    Pemetrexed + Cisplatin Pemetrexed + Carboplatin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Pemetrexed + Cisplatin Pemetrexed + Carboplatin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 22/65 (33.8%) 28/65 (43.1%)
    Blood and lymphatic system disorders
    Anaemia 3/65 (4.6%) 3 3/65 (4.6%) 3
    Anaemia of malignant disease 0/65 (0%) 0 1/65 (1.5%) 1
    Leukopenia 1/65 (1.5%) 1 1/65 (1.5%) 1
    Neutropenia 0/65 (0%) 0 1/65 (1.5%) 2
    Pancytopenia 0/65 (0%) 0 1/65 (1.5%) 1
    Thrombocytopenia 0/65 (0%) 0 5/65 (7.7%) 5
    Cardiac disorders
    Atrial fibrillation 0/65 (0%) 0 1/65 (1.5%) 1
    Atrial flutter 0/65 (0%) 0 1/65 (1.5%) 1
    Cardiac failure 1/65 (1.5%) 1 2/65 (3.1%) 2
    Cardiovascular disorder 1/65 (1.5%) 1 0/65 (0%) 0
    Tachyarrhythmia 0/65 (0%) 0 1/65 (1.5%) 1
    Tachycardia 1/65 (1.5%) 1 0/65 (0%) 0
    Gastrointestinal disorders
    Abdominal pain 0/65 (0%) 0 1/65 (1.5%) 1
    Dental caries 1/65 (1.5%) 1 0/65 (0%) 0
    Diarrhoea 0/65 (0%) 0 1/65 (1.5%) 1
    Dry mouth 1/65 (1.5%) 1 0/65 (0%) 0
    Duodenal ulcer 0/65 (0%) 0 1/65 (1.5%) 1
    Dysphagia 0/65 (0%) 0 1/65 (1.5%) 1
    Faecaloma 0/65 (0%) 0 1/65 (1.5%) 1
    Flatulence 0/65 (0%) 0 1/65 (1.5%) 1
    Gastritis 0/65 (0%) 0 1/65 (1.5%) 1
    Gastrointestinal haemorrhage 0/65 (0%) 0 1/65 (1.5%) 1
    Ileus 1/65 (1.5%) 1 0/65 (0%) 0
    Nausea 2/65 (3.1%) 2 3/65 (4.6%) 3
    Vomiting 2/65 (3.1%) 2 2/65 (3.1%) 2
    General disorders
    Chest pain 1/65 (1.5%) 1 1/65 (1.5%) 1
    General physical health deterioration 1/65 (1.5%) 1 1/65 (1.5%) 1
    Mucosal inflammation 0/65 (0%) 0 1/65 (1.5%) 1
    Multi-organ failure 1/65 (1.5%) 1 0/65 (0%) 0
    Pain 1/65 (1.5%) 1 0/65 (0%) 0
    Performance status decreased 0/65 (0%) 0 1/65 (1.5%) 1
    Pyrexia 0/65 (0%) 0 1/65 (1.5%) 1
    Infections and infestations
    Aspergillosis 0/65 (0%) 0 1/65 (1.5%) 1
    Cerebral fungal infection 0/65 (0%) 0 1/65 (1.5%) 1
    Infection 0/65 (0%) 0 1/65 (1.5%) 1
    Pneumonia 3/65 (4.6%) 3 2/65 (3.1%) 3
    Respiratory tract infection 1/65 (1.5%) 1 0/65 (0%) 0
    Urinary tract infection 0/65 (0%) 0 1/65 (1.5%) 1
    Investigations
    Blood creatinine increased 1/65 (1.5%) 1 0/65 (0%) 0
    Metabolism and nutrition disorders
    Dehydration 1/65 (1.5%) 1 1/65 (1.5%) 1
    Electrolyte imbalance 0/65 (0%) 0 1/65 (1.5%) 1
    Hypercalcaemia 0/65 (0%) 0 1/65 (1.5%) 1
    Hyperkalaemia 1/65 (1.5%) 1 0/65 (0%) 0
    Hyponatraemia 1/65 (1.5%) 1 0/65 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back pain 0/65 (0%) 0 1/65 (1.5%) 1
    Osteolysis 0/65 (0%) 0 1/65 (1.5%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to central nervous system 0/65 (0%) 0 1/65 (1.5%) 1
    Nervous system disorders
    Convulsion 0/65 (0%) 0 1/65 (1.5%) 1
    Epilepsy 1/65 (1.5%) 1 0/65 (0%) 0
    Grand mal convulsion 1/65 (1.5%) 1 0/65 (0%) 0
    Ischaemic stroke 1/65 (1.5%) 1 0/65 (0%) 0
    Psychiatric disorders
    Anxiety disorder 0/65 (0%) 0 1/65 (1.5%) 1
    Mental disorder due to a general medical condition 0/65 (0%) 0 1/65 (1.5%) 1
    Renal and urinary disorders
    Renal failure acute 2/65 (3.1%) 2 1/65 (1.5%) 1
    Urinary retention 0/65 (0%) 0 1/65 (1.5%) 1
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 1/65 (1.5%) 1 1/65 (1.5%) 1
    Dyspnoea 0/65 (0%) 0 3/65 (4.6%) 3
    Epistaxis 0/65 (0%) 0 1/65 (1.5%) 1
    Haemoptysis 1/65 (1.5%) 1 0/65 (0%) 0
    Pulmonary embolism 0/65 (0%) 0 1/65 (1.5%) 1
    Surgical and medical procedures
    Hip arthroplasty 0/65 (0%) 0 1/65 (1.5%) 2
    Vascular disorders
    Deep vein thrombosis 0/65 (0%) 0 2/65 (3.1%) 2
    Haemorrhage 0/65 (0%) 0 1/65 (1.5%) 1
    Other (Not Including Serious) Adverse Events
    Pemetrexed + Cisplatin Pemetrexed + Carboplatin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 61/65 (93.8%) 59/65 (90.8%)
    Blood and lymphatic system disorders
    Anaemia 12/65 (18.5%) 13 19/65 (29.2%) 27
    Haemoglobinaemia 4/65 (6.2%) 4 12/65 (18.5%) 13
    Leukopenia 17/65 (26.2%) 27 24/65 (36.9%) 41
    Neutropenia 18/65 (27.7%) 27 25/65 (38.5%) 62
    Thrombocytopenia 9/65 (13.8%) 12 18/65 (27.7%) 39
    Eye disorders
    Conjunctivitis 5/65 (7.7%) 5 2/65 (3.1%) 2
    Lacrimation increased 6/65 (9.2%) 6 2/65 (3.1%) 2
    Gastrointestinal disorders
    Constipation 17/65 (26.2%) 18 11/65 (16.9%) 13
    Diarrhoea 10/65 (15.4%) 12 10/65 (15.4%) 13
    Dyspepsia 4/65 (6.2%) 4 5/65 (7.7%) 5
    Nausea 42/65 (64.6%) 77 27/65 (41.5%) 46
    Stomatitis 5/65 (7.7%) 5 0/65 (0%) 0
    Vomiting 24/65 (36.9%) 31 8/65 (12.3%) 10
    General disorders
    Fatigue 25/65 (38.5%) 30 24/65 (36.9%) 31
    Mucosal inflammation 5/65 (7.7%) 5 5/65 (7.7%) 9
    Oedema peripheral 6/65 (9.2%) 6 3/65 (4.6%) 3
    Infections and infestations
    Infection 6/65 (9.2%) 7 4/65 (6.2%) 5
    Rhinitis 2/65 (3.1%) 2 7/65 (10.8%) 7
    Investigations
    Alanine aminotransferase increased 0/65 (0%) 0 4/65 (6.2%) 4
    Blood creatinine increased 5/65 (7.7%) 5 2/65 (3.1%) 3
    Gamma-glutamyltransferase increased 0/65 (0%) 0 5/65 (7.7%) 5
    Weight decreased 3/65 (4.6%) 3 8/65 (12.3%) 9
    Metabolism and nutrition disorders
    Anorexia 16/65 (24.6%) 21 10/65 (15.4%) 12
    Hyponatraemia 4/65 (6.2%) 5 0/65 (0%) 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain 4/65 (6.2%) 4 3/65 (4.6%) 4
    Myalgia 4/65 (6.2%) 6 4/65 (6.2%) 6
    Nervous system disorders
    Dizziness 7/65 (10.8%) 9 3/65 (4.6%) 6
    Headache 7/65 (10.8%) 9 5/65 (7.7%) 7
    Psychiatric disorders
    Insomnia 5/65 (7.7%) 5 7/65 (10.8%) 8
    Respiratory, thoracic and mediastinal disorders
    Cough 4/65 (6.2%) 4 8/65 (12.3%) 8
    Dyspnoea 13/65 (20%) 13 10/65 (15.4%) 11
    Epistaxis 5/65 (7.7%) 5 5/65 (7.7%) 5
    Skin and subcutaneous tissue disorders
    Alopecia 6/65 (9.2%) 6 6/65 (9.2%) 6
    Hyperhidrosis 2/65 (3.1%) 2 4/65 (6.2%) 6
    Pruritus 3/65 (4.6%) 3 5/65 (7.7%) 6
    Rash 3/65 (4.6%) 4 4/65 (6.2%) 7
    Vascular disorders
    Hypertension 4/65 (6.2%) 4 0/65 (0%) 0

    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:
    NCT00402051
    Other Study ID Numbers:
    • 11077
    • H3E-SB-S109
    First Posted:
    Nov 22, 2006
    Last Update Posted:
    Feb 17, 2010
    Last Verified:
    Feb 1, 2010