Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy With or Without Prednisone in Treating Patients With Recurrent and/or Metastatic Kidney Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Not specified	Other	UNM-1598C NCI-V98-1477, NCT00003584

Objectives

I.  Estimate the response rate of vinorelbine and estramustine in patients 
with metastatic and/or recurrent renal cell carcinoma.

II.  Obtain pilot data exploring the value of anti-inflammatory treatment in 
the management of severe systemic symptoms and improvement of treatment 
tolerance in this patient population.

Entry Criteria

Disease Characteristics:

Histologically proven metastatic and/or recurrent renal cell carcinoma

Bidimensionally measurable disease required (outside any prior radiation
fields)

No untreated brain metastases

Prior/Concurrent Therapy:

Biologic therapy:
 No concurrent biologic therapy

Chemotherapy:
 No prior vinca alkaloid
 No other concurrent chemotherapy

Endocrine therapy:
 No concurrent hormone therapy
 No concurrent corticosteroids (topical or inhaled corticosteroids allowed)

Radiotherapy:
 At least 4 weeks since prior radiotherapy
 Less than 25% of bone marrow irradiated
 No concurrent radiotherapy

Surgery:
 At least 3 weeks since prior surgery

Other:
 No other concurrent investigational drugs

Patient Characteristics:

Age:
 Not specified

Performance status:
 Not specified

Life expectancy:
 Not specified

Hematopoietic:
 Not specified

Hepatic:
 Not specified

Renal:
 Not specified

Other:
 Not pregnant or nursing
 Fertile patients must use effective contraception
 No other serious illness
 No serious active infection requiring therapy
 HIV negative

Expected Enrollment

A maximum of 35 patients will be accrued for this study.

Outline

Patients are stratified according to number of risk factors (0,1 versus 2 
versus 3).

Patients receive vinorelbine IV on days 1, 8, 15, 22, 28, and 35.  Patients 
also receive estramustine orally twice per day on days 1-7 and an increased 
dose on days 8-42.  A tapered dose of oral prednisone is given to patients 
with an elevated erythrocyte sedimentation rate.  A course of treatment 
consists of 6 weeks of treatment followed by 2 weeks of rest.  Patients with 
stable disease may receive up to 4 courses of treatment.  Patients who achieve 
a partial response may undergo surgical resection followed by up to 2 
additional courses of treatment or an interleukin-2 treatment regimen.  
Patients with a complete response receive 1 additional course of treatment.

Patients are followed until death.

Trial Contact Information

Trial Lead Organizations

University of New Mexico Cancer Center

Laurence Elias, MD, Protocol chair(Contact information may not be current)		Ph: 505-272-5837 Email: lelias@salud.unm.edu

Registry Information
Official Title		A Phase II Trial of Combination Vinorelbine-Estramustine With or Without Prednisone for High Risk and Recurrent, Advanced and Metastatic Renal Cell Carcinoma
Trial Start Date		1998-07-17
Registered in ClinicalTrials.gov		NCT00003584
Date Submitted to PDQ		1998-09-24
Information Last Verified		2000-12-01

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