Overview

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

Status:
Completed
Trial end date:
2002-04-01
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Doxorubicin
Liposomal doxorubicin
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

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

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