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3-AP in Treating Patients With Previously Untreated Locally Recurrent or Metastatic Renal Cell Carcinoma

Kidney Cancer Clinical Trial

Official title:
A Phase II Study of Triapine (NSC 663249) in Previously Untreated Patients With Recurrent Renal Cell Carcinoma

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as 3-AP, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of 3-AP in treating patients who have locally recurrent or metastatic renal cell (kidney) carcinoma (cancer).

Clinical Trial Description

OBJECTIVES: Primary - Determine the efficacy of 3-AP (Triapine®), in terms of objective response rate, in patients with previously untreated locally recurrent or metastatic renal cell carcinoma. Secondary - Determine the adverse events and tolerability of this drug in these patients. - Determine the time to disease progression and overall survival of patients treated with this drug. OUTLINE: This is a nonrandomized, multicenter study. Patients receive 3-AP (Triapine®) IV over 2 hours on days 1-4 and 15-18. Treatment repeats every 28 days for up to 6 courses (for stable patients) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional course after documentation of CR. Patients who achieve a partial response (PR) receive 2 additional courses after documentation of stable PR. Patients are followed every 4 weeks until relapse and then every 3 months for up to 2 years. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 1 year. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00075660
Study type Interventional
Source Canadian Cancer Trials Group
Contact
Status Completed
Phase Phase 2
Start date May 11, 2004
Completion date September 22, 2008
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