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

This study is no longer recruiting patients.

Sponsored by: University of New Mexico
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Prednisone may help to relieve symptoms in patients with recurrent and/or metastatic kidney cancer. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of vinorelbine and estramustine with or without prednisone in treating patients who have recurrent and/or metastatic kidney cancer.

Condition Treatment or Intervention Phase
Stage IV Renal Cell Cancer
childhood kidney/urinary cancer
recurrent renal cell cancer
 Drug: estramustine
 Drug: prednisone
 Drug: vinorelbine
Phase II

MedlinePlus related topics:  Cancer;   Kidney Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Vinorelbine and Estramustine With or Without Prednisone in Patients With Recurrent and/or Metastatic Renal Cell Carcinoma

Further Study Details: 

Study start: July 1998

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.

PROTOCOL 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.

Eligibility

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--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

Location Information


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

Study chairs or principal investigators

Laurence Elias,  Study Chair,  University of New Mexico   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066653; UNM-1598C; NCI-V98-1477
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003584
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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