Dexrazoxane and Cisplatin in Treating Patients With Advanced Solid Tumors

NCT ID: NCT00550901

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-02-28
• Study Completion Date: 2007-07-31

Brief 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.

Detailed Description

OBJECTIVES:

• To establish the maximum tolerated dose of a 96-hour continuous infusion of dexrazoxane hydrochloride and a single-dose, one-hour infusion of cisplatin in patients with advanced solid tumors.
• To determine the pharmacokinetics of dexrazoxane hydrochloride and cisplatin when given concurrently.
• To describe the toxicities of infusional dexrazoxane hydrochloride and cisplatin given in combination.

OUTLINE: Patients receive dexrazoxane hydrochloride IV continuously over 96 hours beginning on day 1 and cisplatin IV over 1 hour on day 3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Blood is collected periodically during course one for pharmacokinetic studies. DNA isolated from the samples is also analyzed for oxidative DNA damage by gas chromatography/mass spectrometry.

After completion of study treatment, patients are followed periodically.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Primary Study Purpose: TREATMENT

Interventions

cisplatin

Intervention Type: DRUG

dexrazoxane hydrochloride

Intervention Type: DRUG

high performance liquid chromatography

Intervention Type: OTHER

laboratory biomarker analysis

Intervention Type: OTHER

mass spectrometry

Intervention Type: OTHER

pharmacological study

Intervention Type: OTHER

Eligibility Criteria

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:

• 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

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy or chemotherapy and recovered
• Recovered from prior major surgery

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:

• Concurrent treatment for severe infection

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

City of Hope Medical Center

Principal Investigators

Stephen I. Shibata, MD

Role: STUDY_CHAIR

City of Hope Comprehensive Cancer Center

Other Identifiers

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHNMC-00136

Identifier Type: -

Identifier Source: secondary_id

CDR0000570420

Identifier Type: -

Identifier Source: org_study_id