Pemetrexed and Cisplatin as Treatment in Small Cell Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine if cisplatin and pemetrexed are effective in the treatment of patients with Small Cell Lung Cancer, extended disease.

Official Title
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Phase II Study of Pemetrexed Plus Cisplatin in the Treatment of Patients With Extensive Small Cell Lung Cancer

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Drug: pemetrexed
* Drug: cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic or cytologic diagnosis of Small Cell Lung Cancer (SCLC). Functional stage from 0 to 2 of the ECOG functional scale No previous systemic chemotherapy, immunotherapy or biologic therapy for SCLC. Previous bone marrow radiotherapy less than 25% is allowed. There must be at least one measurable lesion that complies with the solid tumor response evaluation criteria. Appropriate organic function. Life expectancy estimated at 12 weeks minimum. Females must be surgically sterile, postmenopausal or follow approved medical contraceptive methods during the treatment period and 6 months afterwards. Males must be surgically sterile or use a contraceptive method during the treatment period and during 6 months after treatment. The patient must be compliant and located close to the trial area for appropriate follow-up. The patient or his/her legal representative must sign an informed consent document. Patients must be at least 18 years of age. Exclusion Criteria: Having received treatment for the last 30 days with a drug that has not obtained regulatory approval. Having participated in a previous pemetrexed trial. Mixed histologic diagnosis of SCLC and NSCLC. Concurrent illness. Having an active infection. Severe cardiac disease. Having received recently or concurrently a vaccine against yellow fever. Having suffered a previous malignant process other than SCLC. Central nervous system (CNS) metastases require concurrent corticoid therapy. Treated and stable CNS metastases are allowed. Clinically relevant fluid accumulation in the third space. Significant weight loss (greater than or equal to 10%) within 6 weeks prior to trial inclusion. Concurrent administration of any other anti-tumor treatment. Severe renal failure. Unable to discontinue administration of non-steroidal anti-inflammatory (NSAIDS) agents. Inability or unwillingness to take folic acid and vitamin B12 supplements. Inability to take corticoids.

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>* 500 mg/m2, intravenous (IV), every 21 days x 6 cycles<br>* Other names: Alimta;Drug: cisplatin<br>* 75 mg/m2, 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 |
| --- | --- | --- |
| Overall Response Rate | Trial terminated - results not analyzed | baseline to measured progressive disease | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Trial terminated - results not analyzed | baseline to date of death from any cause | 
| Progression Free Survival | Trial terminated - results not analyzed | baseline to measured progressive disease | 
| Duration of Response | Trial terminated - results not analyzed | time of response to progressive disease | 
| Stable Disease Rate | Trial terminated - results not analyzed | baseline to measured progressive disease |