Oral Estramustine and Oral Vinorelbine in the Treatment of Hormone-Refractory Prostate Cancer

Sponsor

University of Michigan Rogel Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00151086

Collaborator

GlaxoSmithKline (Industry)

Enrollment

Location

Arm

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Purpose: This clinical trail will combine the chemotherapy drugs, Estramustine and Vinorelbine (Navelbine), on an intermittent therapy strategy based on PSA response in the treatment of hormone refractory prostate cancer. The investigators will determine the tolerable dose of (oral) vinorelbine in combination with (oral) estramustine, and evaluate the efficacy of this treatment for patients with hormone-refractory prostate cancer.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Estramustine Drug: Vinorelbine	Phase 1/Phase 2

Detailed Description

Hormone Refractory prostate cancer refers to advanced disease in which a patient no longer responds to conventional hormonal treatment. When hormone therapy is no longer successful, chemotherapy is a treatment option. However, current single-agent treatment has shown to have limited benefit. In this clinical trial, investigators are evaluating the effectiveness of combining two chemotherapy drugs, Estramustine and Vinorelbine (Navelbine), in the treatment of hormone refractory prostate cancer. Estramustine has been used in the treatment of prostate cancer for many years. Vinorelbine has shown activity in prostate cancer. In addition, the effect of this treatment on the quality of life of patients will be evaluated as measured using the FACT-P.

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I/II Evaluation of Oral Estramustine and Oral Vinorelbine on an Intermittent Schedule in Patients With Hormone-Refractory Adenocarcinoma of the Prostate

Study Start Date :

Dec 1, 2001

Actual Primary Completion Date :

Mar 1, 2004

Actual Study Completion Date :

Aug 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Estramustine and Vinorelbine Treatment will consist of 28-day cycles with estramustine at a dose of 140mg orally 3 times per day on days 1-3 and 8-10 and vinorelbine orally on days 2 and 9 beginning at dose 50mg/m^2.	Drug: Estramustine Drug: Vinorelbine

Arm

Intervention/Treatment

Experimental: Estramustine and Vinorelbine

Treatment will consist of 28-day cycles with estramustine at a dose of 140mg orally 3 times per day on days 1-3 and 8-10 and vinorelbine orally on days 2 and 9 beginning at dose 50mg/m^2.

Drug: Estramustine

Drug: Vinorelbine

Outcome Measures

Primary Outcome Measures

Tolerable Dose of Vinorelbine in Combination with Estramustine [180 days post dose]
To determine the tolerable dose of oral vinorelbine in combination with oral estramustine on an intermittent schedule, and describe the toxicities of the regimen. The dose will not be escalated until at least 180 days of cumulative observation of acute toxicity in patients enrolled at a particular dose level.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion:

Patients must have a histologic diagnosis of adenocarcinoma of the prostate. (No evidence of brain metastasis or untreated spinal cord compression.)
Patients on total androgen suppression therapy must undergo nonsteroidal antiandrogen withdrawal and demonstrate at rising PSA (Prostate Specific Antigen) 4 weeks after withdrawal for flutamide and 6 weeks after withdrawal for bicalutamide or nilutamide.
Patients must have measurable soft tissue disease or evaluable (abnormal bone scan and/or elevated PSA). If PSA is the only evidence of progressive disease it must be greater than or equal to 4ng/mL.
Adequate bone marrow, renal and liver function
ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 (a measure of general well being on a scale of 0-5 where 0 represents asymptomatic and 5 represents death)
Must be at least 18 years of age
Must have a life expectancy of greater than or equal to 12 weeks

Exclusion:

Have previously received vinca alkaloid-based cytotoxic chemotherapy or radiation to greater than or equal to 50% of the total bone marrow.
Evidence of brain metastasis
Spinal cord compression
Prior malignancy except for in situ carcinoma, nonmelanoma skin cancer, or adequately treated malignancy that has been inactive for less than 3 years
Patients with preexisting neuropathy of greater than or equal to grade 2
Active gastrointestinal disease, or a disorder that alters gastrointestinal motility or absorption

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

University of Michigan Rogel Cancer Center
GlaxoSmithKline

Investigators

Principal Investigator: David C. Smith, MD, The University of Michigan Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Michigan Rogel Cancer Center

ClinicalTrials.gov Identifier:

NCT00151086

Other Study ID Numbers:

UMCC 2001-050

First Posted:

Sep 8, 2005

Last Update Posted:

Jan 22, 2015

Last Verified:

Jan 1, 2015

Additional relevant MeSH terms:

Prostatic Neoplasms

Vinorelbine

Estramustine

Study Results

No Results Posted as of Jan 22, 2015