Pemetrexed/Carboplatin Non-Small Cell Lung Cancer (NSCLC) Elderly Patients

Study Overview
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Brief Summary
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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

Official 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

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: pemetrexed
* Drug: carboplatin


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pemetrexed + Carboplatin<br>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. | Drug: pemetrexed<br>* 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles<br>* Other names: Alimta;Drug: carboplatin<br>* Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response) | 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. | baseline to measured objective tumor response (up to six 21-day cycles) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Treatment Failure | 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. | baseline to stopping treatment (up to six 21-day cycles) | 
| Overall Survival | Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. | baseline to date of death from any cause (up to 14.5 months) | 
| Estimated Probability of One Year Progression-free Survival | 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. | baseline to measured progressive disease or death, 1 year |