Completed

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

What is being tested

cisplatin

+ gemcitabine hydrochloride

Drug

Who is being recruted

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: August 1999

See protocol details

Summary

Principal SponsorNorthwestern University

Last updated: July 10, 2013

Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00004090

Principal SponsorNorthwestern University

Last updated: July 10, 2013

Sourced from a government-validated database.Claim as a partner

Protocol

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

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, United StatesOpen Robert H. Lurie Comprehensive Cancer Center, Northwestern University in Google Maps

Cancer Institute of New Jersey

New Brunswick, United States

Completed2 Study Centers