VX-710, Doxorubicin, and Vincristine in Treating Patients With Recurrent Small Cell Lung Cancer
Recruitment status was Active, not recruiting
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 in treating patients who have recurrent small cell lung cancer following treatment.
Drug: biricodar dicitrate
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of the Safety, Efficacy and Pharmacokinetics of VX-710 in Combination With Doxorubicin and Vincristine in Patients With Small Cell Lung Cancer (SCLC)|
|Study Start Date:||December 1998|
OBJECTIVES: I. Establish the safety of VX-710 in combination with doxorubicin and vincristine in patients with recurrent small cell lung cancer. II. Characterize the plasma pharmacokinetics of this regimen in these patients. III. Establish the ability of this regimen to improve the response rate to chemotherapy in these patients who have relapsed on front line therapy. IV. Evaluate the multidrug resistance profile of these patients in response to this regimen.
OUTLINE: This is a multicenter study. Stage I: Patients receive VX-710 IV over 72 hours, followed by doxorubicin IV and vincristine IV four hours after initial VX-710. Vincristine is administered at half dose in the first 3-6 patients. If no more than 1 of 6 patients experiences dose limiting toxicity in the half dose cohort, 3 additional patients receive full dose vincristine. The maximum tolerated dose is defined as the dose preceeding that at which 2 of 6 patients experience dose limiting toxicity. Stage II: Patients receive VX-710 IV over 72 hours, followed by doxorubicin IV and full dose vincristine IV four hours after initial VX-710. Treatment continues for up to 6 courses every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for up to 1 year.
PROJECTED ACCRUAL: A minimum of 35 and a maximum of 92 patients will be accrued for this study.
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202-5265|
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Fallon Clinic Inc.|
|Worcester, Massachusetts, United States, 01605|
|United States, Missouri|
|St. John's Mercy Medical Center|
|Saint Louis, Missouri, United States, 63141|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|Study Chair:||Matthew Harding, PhD||Vertex Pharmaceuticals Incorporated|