A Study to Treat Small Cell Lung Cancer With a Combination of Cisplatin, Pemetrexed, and Radiotherapy

Study Overview
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Brief Summary
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The purpose of this study is to determine the recommended dose of pemetrexed, cisplatin and radiotherapy in the treatment of patients with Small Cell Lung Cancer.

Official Title
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Phase I/II Study of Concurrent Cisplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer

Conditions
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Small Cell Lung Cancer, Carcinoma, Small Cell, SCLC

Intervention / Treatment
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* Drug: pemetrexed
* Drug: cisplatin
* Radiation: radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Measurable disease with diagnosis of Small Cell Lung Cancer. Performance status of 0 to 1 on the Eastern Cooperative Oncology Group performance status schedule. Patients must be at least 18 years of age and have at least a 12-week life expectancy. No prior chemotherapy and/or prior thoracic radiotherapy. Adequate pulmonary function and organ function. Exclusion Criteria: Patients with myocardial infarction within the preceding six months. Diagnosis of a serious concomitant systemic disorder. Prior radiotherapy to the lower neck or abdominal region. Significant weight loss. Concurrent administration of any other antitumor therapy.

Ages Eligible for Study
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Minimum Age: 18 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: A<br> | Drug: pemetrexed<br>* Phase 1: 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation) Phase 2: 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles<br>* Other names: Alimta;Drug: cisplatin<br>* Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles<br>Radiation: radiation<br>* Phase 1 and Phase 2: 50-62 Gy, 25-31 days, cycles 2-4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1: Maximum Tolerated Dose |  | every cycle | 
| Phase 2: Overall Response Rate | Overall Response Rate (ORR) was defined as the proportion of participants having either a Complete or Partial response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions. | baseline to measured progressive disease | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1: Best Overall Response | Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. | baseline to measured response | 
| Phase 2: Complete Response Rate | Complete Response Rate was defined as the proportion of participants having a Complete Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions. | baseline to measured response time | 
| Phase 2: Time to Progressive Disease | Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. | baseline to measured progressive disease | 
| Phase 2: Duration of Response | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. | time of response to progressive disease | 
| Phase 2: Overall Survival | Overall survival was the duration from enrollment to death. For patients who were alive, overall survival was censored at the last contact. | baseline to date of death from any cause |