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ZD0473 and Doxorubicin in Treating Patients With Advanced Solid Tumors or Lymphoma



ZD0473 and Doxorubicin in Treating Patients With Advanced Solid Tumors or Lymphoma

For Condition: Eye Cancer,Leukemia,Lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed advanced or metastatic solid tumors or lymphoma; Refractory to standard curative therapy OR No curative therapy exists - Serologically, clinically, and/or radiographically assessable disease - No newly diagnosed brain metastases; Intracranial disease that is stable for at least 6 months allowed --Prior/Concurrent Therapy-- - Biologic therapy: At least 5 days since prior immunotherapy - Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas and similar compounds); No more than 3 prior chemotherapy regimens for metastatic disease; No prior anthracycline exposure exceeding 300 mg/m2 doxorubicin; No prior doxorubicin HCl liposome - Endocrine therapy: At least 5 days since prior hormonal therapy - Radiotherapy: At least 3 weeks since prior radiotherapy and recovered; No prior radiotherapy to more than 30% of functioning bone marrow - Surgery: At least 3 weeks since prior major surgery - Other: No other concurrent experimental drugs; No other concurrent anticancer therapy --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than upper limit of normal (ULN); AST or ALT no greater than 2.0 times ULN; Alkaline phosphatase no greater than 2.0 times ULN - Renal: Creatinine no greater than ULN; Creatinine clearance at least 60 mL/min - Cardiovascular: Ejection fraction at least 50% - Other: No underlying medical condition that would preclude study or that is uncontrolled; No active serious infection; No neurotoxicity or preexisting grade 3 or higher neuropathy; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
DavidSpriggs,  Study Chair,  Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center
New York City,  New York,  10021
United States
 


Additional Information:
Study ID Numbers:  CDR0000068603;  NCI-G01-1942,MSKCC-00044
Study Start Date: November 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016172

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