Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer

Study Overview
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Brief Summary
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This proposed phase II trial will investigate the combination of topotecan/carboplatin in the first-line treatment of patients with extensive-stage SCLC. Topotecan/platinum regimens are emerging as common treatments for patients with extensive-stage disease. This trial will be one of the first clinical trials to evaluate a combination of weekly topotecan and carboplatin in the first-line treatment of extensive-stage SCLC.

Detailed Description
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Eligible patients will receive treatment with carboplatin and topotecan. Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)

Official Title
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A Phase II Trial of Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer

Conditions
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Carcinoma, Small Cell

Intervention / Treatment
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* Drug: Topotecan
* Drug: carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have confirmed small cell lung cancer with extensive stage disease. This includes patients with stage IIIB and IV disease. Patients with small cell histology are eligible. Large neuroendocrine or mixed small cell and non-small cell histology are not eligible. Patients must have measurable or evaluable disease. ECOG performance status 0 or 1. Patients must have adequate bone marrow, liver and kidney function The patients may have had no previous chemotherapy. Patients must be able to understand the nature of the study and give written informed consent. Exclusion Criteria: Patients with limited stage disease. This includes IA, IB, IIA, IIB, and IIIA. Age < 18 years old. History of a prior malignancy within three years with the exception of skin cancer (excluding melanoma), cervical carcinoma in situ, in situ breast carcinoma or stage A/B prostate cancer. Female patients who are pregnant or are breast feeding History of acute myocardial infarction or stroke within 6 months. Uncontrolled hypertension, unstable angina, New York Heart Association grade II or greater CHF, serious cardiac arrhythmia requiring medication, or grade II or greater peripheral vascular disease. Patients who have received other investigational drugs within 28 days. Patients with CNS involvement (brain or meningeal). The single exception to this is the patient previously treated for brain metastases with radiation therapy, or surgical excision who has no evidence of active residual metastases on brain MRI at the time of study entry. Patients with large neuroendocrine tumor or mixed small cell and non-small cell histology

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.) | Drug: Topotecan<br>* Topotecan 4mg/m2 IV on days 1, 8.<br>* Other names: Hycamtin;Drug: carboplatin<br>* Carboplatin AUC=5 IV day 1 only .<br>* Other names: 41575-94-4;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment | Overall response rate is the percent of patients experiencing a complete or partial response by RECIST v. 1 Criteria. Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. The final response category assigned represented the best response obtained during treatment. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease | Time to progression is defined as the interval between the start date of treatment and the date of occurrence of progressive disease. | 18 months | 
| Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death | Overall survival was measured from the date of study entry until the date of death. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer, Carcinoma, Small Cell