VX-853 in Treating Patients With Solid Tumors Who Are Receiving Liposomal Doxorubicin
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of VX-853 in treating patients who have solid tumors who are receiving liposomal doxorubicin.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: pegylated liposomal doxorubicin hydrochloride
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I/II Study of the Pharmacokinetics, Tolerability and Safety of Administration of VX-853 to Patients Receiving Single Agent Therapy With Doxorubicin HCI|
|Study Start Date:||March 1996|
|Study Completion Date:||January 2001|
|Primary Completion Date:||January 2001 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the safety and tolerability of VX-853 in combination with doxorubicin HCl liposome in patients with relapsed or incurable solid tumors. II. Obtain pharmacokinetic profiles for various dosages of VX-853 administered in combination with doxorubicin HCl liposome. III. Achieve whole blood concentrations of VX-853 in the predicted therapeutically effective range and characterize the pharmacokinetics at these doses. IV. Document antitumor effects of VX-853 in combination with doxorubicin HCl liposome in these patients.
OUTLINE: This is a dose escalation study of VX-853. Patients receive VX-853 orally every 8 hours on days 1-3 and doxorubicin HCL liposome IV over approximately 15 minutes beginning 26 hours after starting VX-853. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of VX-853 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within approximately 18 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004030
|United States, District of Columbia|
|Vincent T. Lombardi Cancer Research Center, Georgetown University|
|Washington, District of Columbia, United States, 20007|
|Study Chair:||Michael J. Hawkins, MD||Lombardi Comprehensive Cancer Center|