Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer

Phase 1

Completed

• Conditions: Lung Cancer
• Interventions: Drug: topotecan hydrochloride; Drug: vinorelbine tartrate

• Registration Number: NCT00287963
• Lead Sponsor: Medical University of South Carolina

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with vinorelbine in treating patients with recurrent lung cancer.

Detailed Description

OBJECTIVES:

Primary

* Determine the maximum tolerated dose of topotecan when combined with vinorelbine ditartrate in patients with recurrent lung cancer.

Secondary

* Assess the response and stable disease rates and the time to disease progression among treated patients.

OUTLINE: This is a dose-escalation study of topotecan.

Patents receive vinorelbine ditartrate IV over 8-10 minutes and topotecan IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which ≥ 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2006-02-06
• Study First Submitted QC: 2006-02-06
• Study First Posted: 2006-02-07
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-14
• Last Update Posted: 2018-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vinorelbine + topotecan	vinorelbine tartrate	-
Vinorelbine + topotecan	topotecan hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose	Cycle 1 (up to day 21)

Secondary Outcome Measures

Name	Time	Method
Response rate	while on study, at the end of each 3 week cycle
stable disease rate	while on study, at the end of each 3 week cycle
time to progression	from start of treatment to day of documented progression or death, whichever comes first, up to 36 months

Trial Locations

Locations (1)

Hollings Cancer Center at Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States