SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract
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|ClinicalTrials.gov Identifier: NCT00006351|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 24, 2012
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining SCH 66336 and gemcitabine may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of SCH 66336 plus gemcitabine in treating patients who have advanced cancer of the urinary tract.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer||Drug: gemcitabine hydrochloride Drug: lonafarnib||Phase 2|
- Determine the feasibility and toxicity of SCH 66336 and gemcitabine in patients with advanced transitional cell carcinoma of the urinary tract.
- Determine the time to progression and objective response rate of this treatment regimen in these patients.
- Assess the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral SCH 66336 twice a day (starting on day 2 of the first course, and starting on day 1 of all subsequent courses). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks until disease progression.
PROJECTED ACCRUAL: A total of 7-31 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Official Title:||Phase II Study on SCH 66336 (Farnesyl Protein Transferase Inhibitor) and Gemcitabine as Second Line Treatment in Advanced Metastatic Urothelial Cancer - EORTC Study 16997|
|Study Start Date :||June 2000|
|Actual Primary Completion Date :||December 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006351
|University Medical Center Nijmegen|
|Nijmegen, Netherlands, 6500|
|Study Chair:||Ronald De Wit, MD, PhD||Daniel Den Hoed Cancer Center at Erasmus Medical Center|
|Study Chair:||Pieter H. M. de Mulder, MD, PhD||Universitair Medisch Centrum St. Radboud - Nijmegen|
|Study Chair:||Godefridus Peters, PhD||Free University Medical Center|