3-AP in Treating Patients With Previously Untreated Locally Recurrent or Metastatic Renal Cell Carcinoma
- Conditions
- Kidney Cancer
- Registration Number
- NCT00075660
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief 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).
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
British Columbia Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Margaret and Charles Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal
🇨🇦Montreal, Quebec, Canada