Overview

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

Status:
Completed
Trial end date:
2002-08-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Northwestern University
Collaborator:
National Cancer Institute (NCI)
Treatments:
Cisplatin
Gemcitabine
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