Dexrazoxane and Cisplatin in Treating Patients With Advanced Solid Tumors

NCT00550901 | Completed Phase 1

• 3 other identifiers: CDR0000570420P30CA033572CHNMC-00136
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (2)

• Toxicity

• Maximum tolerated dose of dexrazoxane hydrochloride and cisplatin

Interventions

cisplatin DRUG

dexrazoxane hydrochloride DRUG

high performance liquid chromatography OTHER

laboratory biomarker analysis OTHER

mass spectrometry OTHER

pharmacological study OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• See Disease Characteristics
• At least 4 weeks since prior radiotherapy or chemotherapy and recovered
• Recovered from prior major surgery
• Concurrent treatment for severe infection

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Interventions

Cisplatin; Dexrazoxane; Chromatography, High Pressure Liquid; Mass Spectrometry

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Razoxane; Diketopiperazines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chromatography, Liquid; Chromatography; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Stephen I. Shibata, MD

  City of Hope Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 25, 2007
• First Posted: October 30, 2007
• Study Start: February 1, 2001
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: June 8, 2015

Record last verified: 2015-06