Gemcitabine and Cisplatin in Treating Patients With Metastatic or Recurrent Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of gemcitabine and cisplatin in treating patients who have metastatic or recurrent solid tumors.

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Key information

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States

About this study

OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of gemcitabine and cisplatin in patients with metastatic or recurrent nonhematologic malignancies.

OUTLINE: This is a dose escalation study of gemcitabine. Patients receive gemcitabine IV on days 1 and 8, followed immediately by cisplatin IV over 2 hours on day 8. Courses repeat every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-5 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 5 patients experience dose limiting toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 18 patients will be accrued for this study within 18 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic or recurrent nonhematologic malignancy that is not amenable to or has failed standard therapy Measurable or evaluable disease No uncontrolled brain metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: At least 8 weeks Hematopoietic: Neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Pulmonary: No respiratory failure Other: Not pregnant or nursing Fertile patients must use effective contraception No active infection or other concurrent severe medical illness that would interfere with compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas) and recovered No prior cisplatin or gemcitabine Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified

Treatment and study plan

Cisplatin

Drug

gemcitabine hydrochloride

Drug

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

Gemcitabine (10 mg/m2/Min) and Cisplatin: A Phase I Study

Important dates

Study start: 1999
Primary completion: 2002
Study completion: 2002
First posted: Aug 30, 2004
Registry last updated: Jul 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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