Gemcitabine (10 mg/m2/Min) and Cisplatin: A Phase I Study
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Gemcitabine (10 mg/m2/Min) and Cisplatin: A Phase I 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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Al B. Benson, MD, FACP
Investigator Role:
Study Chair
Investigator Affiliation:
Robert H. Lurie Cancer Center
Authority:
United States: Federal Government
Study ID:
NU CINJ98X1
NCT ID:
NCT00004090
Start Date:
August 1999
Completion Date:
August 2002
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
| Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
