ZD0473 and Doxorubicin in Treating Patients With Advanced Solid Tumors or Lymphoma
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 cancer cells.
PURPOSE: Phase I trial to study the effectiveness of combining ZD0473 and doxorubicin in treating patients who have advanced solid tumors or lymphoma.
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: pegylated liposomal doxorubicin hydrochloride
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of ZD0473 and Doxil in Patients With Advanced Refractory Cancer|
|Study Start Date:||November 2000|
|Study Completion Date:||April 2002|
|Primary Completion Date:||April 2002 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the maximum tolerated dose of ZD0473 and doxorubicin HCl liposome in patients with advanced or metastatic solid tumors or lymphoma. II. Determine the qualitative and quantitative toxic effects of this regimen in this patient population. III. Determine the pharmacokinetics of these drugs in this patient population. IV. Determine the antitumor activity of this regimen in this patient population.
OUTLINE: This is a dose-escalation study. Patients receive doxorubicin HCl liposome IV over 60 minutes followed by ZD0473 IV over 60 minutes on day 1. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients with partial response (PR) or complete response (CR) may continue treatment until disease progression or until 2 courses after maximum response. Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome and ZD0473 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity. Patients are followed at 4 weeks and 3 months. Patients with PR or CR ongoing continue follow-up every 3 months until relapse.
PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00016172
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||David R. Spriggs, MD||Memorial Sloan-Kettering Cancer Center|