3-AP in Treating Patients With Previously Untreated Locally Recurrent or Metastatic Renal Cell Carcinoma
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).
|Study Design:||Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Triapine (NSC 663249) in Previously Untreated Patients With Recurrent Renal Cell Carcinoma|
|Study Start Date:||January 2004|
|Study Completion Date:||September 2008|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075660
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|British Columbia Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Winnipeg, Manitoba, Canada, R3E 0V9|
|Margaret and Charles Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Care Ontario-London Regional Cancer Centre|
|London, Ontario, Canada, N6A 4L6|
|Toronto Sunnybrook Regional Cancer Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2C4|
|Centre Hospitalier de l'Universite de Montreal|
|Montreal, Quebec, Canada, H2L-4M1|
|Study Chair:||Jennifer Knox, MD||Toronto General Hospital|