Pemetrexed/Carboplatin Non-Small Cell Lung Cancer (NSCLC) Elderly Patients
- Registration Number
- NCT00350792
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
A phase II study to evaluate the efficacy and safety profile of the combination of Pemetrexed and Carboplatin in elderly patients with advanced non-small cell lung cancer
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pemetrexed + Carboplatin pemetrexed Pemetrexed: 500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 6 cycles. Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles. Pemetrexed + Carboplatin carboplatin Pemetrexed: 500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 6 cycles. Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
- Primary Outcome Measures
Name Time Method Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response) baseline to measured objective tumor response (up to six 21-day cycles) Tumor response is defined as the percentage of patients with either a complete response or a partial response. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions and Partial Response=30% decrease in sum of longest diameter of target lesions.
- Secondary Outcome Measures
Name Time Method Time to Treatment Failure baseline to stopping treatment (up to six 21-day cycles) Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.
Overall Survival baseline to date of death from any cause (up to 14.5 months) Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Estimated Probability of One Year Progression-free Survival baseline to measured progressive disease or death, 1 year Progression free survival (PFS) is the duration from enrollment until first disease progression or death. For patients not known to have died as of the data cut-off date and who do not have progressive disease, PFS is censored at the last radiological assessment date.
Trial Locations
- Locations (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.
🇫🇷Vandoeuvre Les Nancy, France