Dexrazoxane and Cisplatin in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as dexrazoxane and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may help kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of dexrazoxane when given together with cisplatin in treating patients with advanced solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Dexrazoxane; Razoxane

Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

• Histologically confirmed advanced, incurable cancer that is unresponsive to prior chemotherapy regimens or for which no standard chemotherapy regimen exists

• History of brain metastases allowed if controlled by radiotherapy or surgery and patient's neurological status is stable

• Concurrent corticosteroids allowed as long as required dose is stable or decreasing

• Not eligible for a higher priority study

PATIENT CHARACTERISTICS:

Inclusion criteria:

• Karnofsky performance status 60-100%

• Life expectancy ≥ 12 weeks

• ANC ≥ 2,000/mm³

• Platelet count ≥ 100,000/mm³

• Serum creatinine ≤ 1.6 mg/dL OR creatinine clearance ≥ 60 mL/min

• Bilirubin ≤ 1.5 mg/dL

• SGOT < 3 times upper limit of normal

• Recovered from any recent severe infection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

Exclusion criteria:

• Patients with any nonmalignant intercurrent illnesses (e.g., cardiovascular, pulmonary, neurologic) that are either poorly controlled with currently available treatment, or are of such severity that the investigators deem it unwise to enter the patient onto this study

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy or chemotherapy and recovered

• Recovered from prior major surgery

Exclusion criteria:

• Concurrent treatment for severe infection