Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer

Phase 2

Terminated

• Conditions: Mediastinal Neoplasms
• Interventions: Drug: Intravenous Topotecan; Drug: Intravenous Docetaxel

• Registration Number: NCT00315211
• Lead Sponsor: Aultman Health Foundation

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2006-04-17
• Study First Submitted QC: 2006-04-17
• Study First Posted: 2006-04-18
• Primary Completion: 2007-06
• Study Completion: 2007-11-08
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-17
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A	Intravenous Topotecan	Weekly intravenous topotecan with intravenous docetaxel
Arm A	Intravenous Docetaxel	Weekly intravenous topotecan with intravenous docetaxel

Primary Outcome Measures

Name	Time	Method
To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel	3 years	To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel

Trial Locations

Locations (1)

Aultman Hospital; 🇺🇸 Canton, Ohio, United States