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A Phase II Trial of Combination Vinorelbine-Estramustine With or Without Prednisone for High Risk and Recurrent, Advanced and Metastatic Renal Cell Carcinoma


Phase 2
N/A
N/A
Open (Enrolling)
Both
Kidney Cancer

Thank you

Trial Information

A Phase II Trial of Combination Vinorelbine-Estramustine With or Without Prednisone for High Risk and Recurrent, Advanced and Metastatic Renal Cell Carcinoma


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.

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.

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

Inclusion 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

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

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Laurence Elias, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of New Mexico Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066653

NCT ID:

NCT00003584

Start Date:

July 1998

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location
University of New Mexico Cancer Research & Treatment Center Albuquerque, New Mexico  87131