Overview

Combination Chemotherapy in Treating Patients With Advanced Cancer

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of vinorelbine, paclitaxel, and estramustine in treating patients who have advanced cancer that has not responded to previous treatment.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
New York University School of Medicine
NYU Langone Health
Collaborator:
National Cancer Institute (NCI)
Treatments:
Albumin-Bound Paclitaxel
Estramustine
Paclitaxel
Vinblastine
Vinorelbine
Criteria
DISEASE CHARACTERISTICS: Phase I: Histologically proven advanced cancer that has failed or
is not amenable to standard treatment Phase II: Histologically proven metastatic prostate
cancer as documented by bone scan and rising PSA Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-2 Life expectancy: Not
specified Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hemoglobin greater than 9 g/dL (transfusion allowed) Hepatic: AST and ALT no
greater than 4 times upper limit of normal Bilirubin no greater than 2 mg/dL Renal:
Creatinine no greater than 2 mg/dL Cardiovascular: No myocardial infarction within the past
year No New York Heart Association class III or IV heart disease No uncontrolled cardiac
dysrhythmia No angina pectoris No uncontrolled hypertension No cardiomyopathy Neurologic:
No prior neuropathy No preexisting neurotoxicity Other: Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Phase I: No prior
vinorelbine (any schedule) or paclitaxel on a 24 hour or longer schedule At least 2 weeks
since prior chemotherapy Phase II: No prior chemotherapy Endocrine therapy: Not specified
Radiotherapy: No radiotherapy to greater than 25% of bone marrow At least 3 weeks since
prior radiotherapy No concurrent radiotherapy during courses 1 and 2. Surgery: No
concurrent oncologic surgery during courses 1 and 2