Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer

Study Overview
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Brief Summary
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The purposes of this study are: To determine the overall response rate of patients treated with at least 2 cycles of this regimen. To determine the feasibility and toxicity of the combination of topotecan and docetaxel.

Detailed Description
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The main objective of this study was to determine the overall response rate of patients treated with at least 2 cycles of topotecan and docetaxel. The secondary objectives were to determine the feasibility and toxicities of this combination. The final secondary objective is overall survival for patients that received 2 or more cycles. Methods: Eligible pts with recurrent small cell lung cancer had to be at least 3 months from initial treatment. Pts received Docetaxel 30 mg/m2 IV followed by Topotecan 3 mg/m2 IV Days 1 and 8 of a 21 day cycle. Disease assessment was done every 2 cycles. Toxicity was measured each cycle.

Official Title
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Phase 2 Study of Weekly Topotecan With Docetaxel for Recurrent Small Cell Lung Cancer

Conditions
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Mediastinal Neoplasms

Intervention / Treatment
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* Drug: Intravenous Topotecan
* Drug: Intravenous Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recurred greater than 90 days after initial treatment At least 1 measurable lesion Only 1 prior chemotherapy Must be over 18 years of age ECOG performance status of 0 - 2 Adequate hematologic, renal, and hepatic function Exclusion Criteria: No prior use of topotecan, docetaxel, or irinotecan No symptomatic brain metastases History of cardiac arrhythmias, congestive heart failure, stroke, or embolic events No prior investigational agents within 1 month prior Lung cancer of mixed histology Known uncontrolled seizure disorders

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 |
| --- | --- |
| Other: Arm A<br>Weekly intravenous topotecan with intravenous docetaxel | Drug: Intravenous Topotecan<br>* Topotecan 3 mg/m2 IV over 30 minutes on Days 1 and 8 every 21 days<br>* Other names: Hycamtin;Drug: Intravenous Docetaxel<br>* Docetaxel 30 mg/m2 IV over 60 minutes on Days 1 & 8 of a 21 day cycle<br>* Other names: Taxotere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel | To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel | 3 years | 

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