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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00350792 |
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Date of registration:
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10/07/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pemetrexed/Carboplatin Non-Small Cell Lung Cancer (NSCLC) Elderly Patients
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Scientific title:
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A Phase II Trial Pemetrexed Carboplatin as First Line Chemotherapy for Advanced Non-Small Cell Lung Cancer (NSCLC) in Elderly Patients |
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Date of first enrolment:
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August 2006 |
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Target sample size:
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62 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00350792 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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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) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Pathologically confirmed Non Small Cell Lung Cancer Stage IIIb (not amenable to
radiotherapy treatment) or Stage IV
- No previous chemotherapy for lung cancer
- Men and women > or = 70 years
- At least one uni-dimensionally measurable lesion (Response Evaluation Criteria In
Solid Tumors [RECIST]criteria)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
Exclusion Criteria:
- Treatment within the last 30 days with a drug that has not received regulatory
approval
- Serious systemic disorders
- Inability to discontinue administration of aspirin or anti-inflammatory non steroid
- Concurrent administration of any other antitumor therapy
- Brain metastasis
Age minimum:
70 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Non Small Cell Lung Cancer
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Intervention(s)
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Drug: pemetrexed
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Drug: carboplatin
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Primary Outcome(s)
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Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response)
[Time Frame: baseline to measured objective tumor response (up to six 21-day cycles)]
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Secondary Outcome(s)
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Overall Survival
[Time Frame: baseline to date of death from any cause (up to 14.5 months)]
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Time to Treatment Failure
[Time Frame: baseline to stopping treatment (up to six 21-day cycles)]
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Estimated Probability of One Year Progression-free Survival
[Time Frame: baseline to measured progressive disease or death, 1 year]
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Secondary ID(s)
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9941
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H3E-FP-S099
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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