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Combination Chemotherapy in Treating Patients With Advanced Cancer



Combination Chemotherapy in Treating Patients With Advanced Cancer

For Condition: Leukemia,Lymphoma,childhood soft tissue sarcoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Kaplan Cancer Center
Synopsis: 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.
Details: OBJECTIVES: I. Establish the maximum tolerated doses (MTDs) and recommended Phase II doses (RPTDs) of vinorelbine and paclitaxel when combined with a fixed dose of estramustine in patients with advanced cancers or metastatic prostate cancer. II. Determine the toxicity pattern of this regimen at the MTDs and at the RPTDs in these patients. III. Make preliminary observations of antitumor activity in these patients treated with this regimen as leads for the Phase II portion of this study. IV. Establish the efficacy of the RPTDs of vinorelbine and paclitaxel when combined with estramustine in patients with prostate cancer who fulfill the criteria for the Phase II portion of this study. PROTOCOL OUTLINE: This is a dose escalation, multicenter study of vinorelbine and paclitaxel. Patients receive oral estramustine every 8 hours on days 0-2 and 7-9 and vinorelbine IV over 6-10 minutes immediately followed by paclitaxel IV over 1 hour on days 2 and 9. Courses repeat every 21 days. Patients with complete response, partial response, or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of vinorelbine and paclitaxel until the maximum tolerated dose (MTD) of each drug is determined. The MTD is defined as the lowest dose at which 2 or more of 3-6 patients experience dose limiting toxicity. The recommended Phase II dose of vinorelbine or paclitaxel is defined as the dose immediately preceding the MTD. PROJECTED ACCRUAL: A minimum of 12-16 patients will be accrued over 1 year for Phase I of the study and a total of 14-25 patients will be accrued for Phase II of the study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
FrancoMuggia,  Study Chair,  Kaplan Cancer Center

NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City,  New York,  10016
United States
 


Additional Information:
Study ID Numbers:  CDR0000067324;  NYU-9712,NCI-G99-1596
Study Start Date: September 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004105

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