Overview

Combination Chemotherapy Plus Amifostine in Treating Patients With Advanced Cancer

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumors from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase I trial to study the effectiveness of amifostine plus combination chemotherapy in treating patients with advanced cancer.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Cleveland Clinic
Treatments:
Amifostine
Carboplatin
Cyclophosphamide
Sargramostim
Criteria
DISEASE CHARACTERISTICS: Histologically proven advanced malignancies that are sensitive to
cyclophosphamide/carboplatin therapy OR refractory to standard therapy, including, but not
limited to: Ovarian epithelial cancer Colorectal cancer Breast cancer Sarcoma Non-small
cell lung cancer Malignant melanoma Upper gastrointestinal cancers Small cell lung cancer

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 SWOG 0-2 Life
expectancy: At least 3 months Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil
count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 8.5 g/dL
Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 60 mL/min OR Iothalamate clearance at least 60 mL/min
Cardiovascular: No significant coronary artery disease (angina of New York Heart
Association class 3 or greater) Other: Not pregnant or nursing Negative pregnancy test
Fertile patients must use effective contraception No psychosis

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: At
least 3 weeks since prior chemotherapy and recovered No more than 1 prior chemotherapy
regimen for advanced or recurrent malignancies (not including adjuvant chemotherapy) No
prior nitrosoureas or intravenous mitomycin No concurrent cytotoxic chemotherapy Endocrine
therapy: At least 1 week since prior hormone therapy and recovered Concurrent
corticosteroid therapy allowed Radiotherapy: At least 3 weeks since prior radiotherapy and
recovered Radiotherapy allowed to no more than 1 site in the thoracic or lumbar spine or
pelvis Concurrent radiotherapy to a symptomatic lesion allowed after the first course of
study treatment Surgery: At least 3 weeks since prior surgery and recovered (excluding
recent biopsy or placement of an intravenous access device)