Combination Chemotherapy in Treating Patients With Advanced Cancer

Lymphoma Clinical Trial

Official title:

A Phase I/II Study of Paclitaxel, Estramustine Phosphate, and Vinorelbine (PaclEVin)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004105
• Other study ID #: CDR0000067324
• Secondary ID: P30CA016087NYU-9
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 10, 1999
• Last updated: March 25, 2011
• Start date: September 1998

Study information

• Verified date: March 2011
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Sarcoma
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• estramustine phosphate sodium

• paclitaxel

• vinorelbine ditartrate

Locations

Country	Name	City	State
United States	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,