Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer

Mediastinal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00315211
• Other study ID #: Hycamtin study #102143
• Secondary ID: Lung 01
• Status: Terminated
• Phase: Phase 2
• Start date: November 2004
• Est. completion date: November 8, 2007

Study information

• Verified date: August 2018
• Source: Aultman Health Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: November 8, 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Mediastinal Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Intravenous Topotecan
Topotecan 3 mg/m2 IV over 30 minutes on Days 1 and 8 every 21 days
• Intravenous Docetaxel
Docetaxel 30 mg/m2 IV over 60 minutes on Days 1 & 8 of a 21 day cycle

Locations

Country	Name	City	State
United States	Aultman Hospital	Canton	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Aultman Health Foundation	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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