Dexrazoxane and Cisplatin in Treating Patients With Advanced Solid Tumors

June 3, 2015 updated by: City of Hope Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Toxicity
Maximum tolerated dose of dexrazoxane hydrochloride and cisplatin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

October 25, 2007

First Submitted That Met QC Criteria

October 26, 2007

First Posted (Estimate)

October 30, 2007

Study Record Updates

Last Update Posted (Estimate)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000570420
  • P30CA033572 (U.S. NIH Grant/Contract)
  • CHNMC-00136

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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