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| Tracking Information | |||||
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| First Received Date ICMJE | December 10, 1999 | ||||
| Last Updated Date | July 23, 2008 | ||||
| Start Date ICMJE | September 1998 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00004105 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Combination Chemotherapy in Treating Patients With Advanced Cancer | ||||
| Official Title ICMJE | A Phase I/II Study of Paclitaxel, Estramustine Phosphate, and Vinorelbine (PaclEVin) | ||||
| Brief 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. |
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| Detailed Description | 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. 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. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00004105 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000067324, NYU-9712, NCI-G99-1596 | ||||
| Study Sponsor ICMJE | New York University School of Medicine | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | February 2001 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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