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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00003584
First received: November 1, 1999
Last updated: May 10, 2016
Last verified: May 2016
  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 Intervention Phase
Kidney Cancer
Drug: estramustine phosphate sodium
Drug: prednisone
Drug: vinorelbine tartrate
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Estimated Enrollment: 35
Study Start Date: July 1998
Study Completion Date: December 2000
Primary Completion Date: December 2000 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003584

Locations
United States, New Mexico
University of New Mexico Cancer Research & Treatment Center
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
Study Chair: Laurence Elias, MD University of New Mexico Cancer Center
  More Information

Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT00003584     History of Changes
Other Study ID Numbers: UNM-1598C  CDR0000066653  NCI-V98-1477 
Study First Received: November 1, 1999
Last Updated: May 10, 2016
Health Authority: United States: Federal Government

Keywords provided by University of New Mexico:
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Prednisone
Estramustine
Vinorelbine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 23, 2016