A Phase II Trial Pemetrexed Carboplatin as First Line Chemotherapy for Advanced Non-Small Cell Lung Cancer (NSCLC) in Elderly Patients
Overview
- Phase
- Phase 2
- Intervention
- pemetrexed
- Conditions
- Non Small Cell Lung Cancer
- Sponsor
- Eli Lilly and Company
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response)
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Pemetrexed + 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.
Intervention: pemetrexed
Pemetrexed + 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.
Intervention: carboplatin
Outcomes
Primary Outcomes
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)
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 Outcomes
- Time to Treatment Failure(baseline to stopping treatment (up to six 21-day cycles))
- Overall Survival(baseline to date of death from any cause (up to 14.5 months))
- Estimated Probability of One Year Progression-free Survival(baseline to measured progressive disease or death, 1 year)