Combination Chemotherapy With or Without Prednisone in Treating Patients With Recurrent and/or Metastatic Kidney Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Cancer
Intervention: estramustine phosphate sodium (Drug); prednisone (Drug); vinorelbine ditartrate (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: University of New Mexico Official(s) and/or principal investigator(s):
Laurence Elias, MD, Study Chair, Affiliation: University of New Mexico
Summary
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.
Clinical Details
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
Study design: Treatment
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
University of New Mexico Cancer Research & Treatment Center, Albuquerque, New Mexico 87131, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: July 1998
Last updated: May 23, 2008
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