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Phase I Study of Cis-Diamminedicholoroplatinum in Combination With ICRF-187 in the Treatment of Advanced Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Study of Cis-Diamminedicholoroplatinum in Combination With ICRF-187 in the Treatment of Advanced Malignancies


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Toxicity

Safety Issue:

Yes

Principal Investigator

Stephen I. Shibata, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000570420

NCT ID:

NCT00550901

Start Date:

February 2001

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

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