VX-710, Doxorubicin, and Vincristine for the Treatment of Patients With Recurrent Small Cell Lung Cancer

Phase 2

Terminated

• Conditions: Lung Cancer
• Interventions: Drug: biricodar dicitrate; Drug: doxorubicin hydrochloride; Drug: vincristine sulfate

• Registration Number: NCT00003847
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy for the treatment of patients who have recurrent small cell lung cancer following treatment.

Detailed Description

OBJECTIVES: I. Established the safety of VX-710 in combination with doxorubicin and vincristine for the treatment of patients with recurrent small cell lung cancer. II. Characterized the plasma pharmacokinetics of this regimen in patients. III. Established the ability of this regimen to improve the response rate to chemotherapy in patients who relapsed on front-line therapy. IV. Evaluated the multidrug resistance profile of these patients following this treatment regimen.

OUTLINE: This was a multicenter study. Stage I: Patients received VX-710 IV over 72 hours, followed by doxorubicin IV and vincristine IV four hours after initial VX-710. Vincristine was administered at half dose in the first 3-6 patients. If no more than 1 of 6 patients experienced a dose limiting toxicity in the half dose cohort, 3 additional patients received full dose vincristine. The maximum tolerated dose was defined as the dose preceding that at which 2 of 6 patients experienced a dose limiting toxicity. Stage II: Patients received VX-710 IV over 72 hours, followed by doxorubicin IV and full dose vincristine IV four hours after initial VX-710. Treatment continued for up to 6 courses every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients were followed every 3 months for up to 1 year.

PROJECTED ACCRUAL: A minimum of 35 and a maximum of 92 patients was to be accrued for this study.

Study Timeline

• Study Start: 1998-12
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-02
• Study First Submitted QC: 2004-06-15
• Study First Posted: 2004-06-16
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-04
• Last Update Posted: 2013-09-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	biricodar dicitrate	-
Treatment	doxorubicin hydrochloride	-
Treatment	vincristine sulfate	-

Primary Outcome Measures

Name	Time	Method
Response Rate	Every 2 Cycles	Analyzed via radiologic imaging according WHO criteria

Trial Locations

Locations (9)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Duke Comprehensive Cancer Center; 🇺🇸 Durham, North Carolina, United States

St. John's Mercy Medical Center; 🇺🇸 Saint Louis, Missouri, United States

Indiana University Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

Fallon Clinic Inc.; 🇺🇸 Worcester, Massachusetts, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States