SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract
This study has been completed.
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00006351
First received: October 4, 2000
Last updated: September 20, 2012
Last verified: September 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer |
Drug: gemcitabine hydrochloride Drug: lonafarnib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:
| Enrollment: | 34 |
| Study Start Date: | June 2000 |
| Primary Completion Date: | December 2001 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic or unresectable primary transitional cell carcinoma of the urinary tract, including bladder, ureter, and renal pelvis
At least one measurable lesion
- 20 mm or greater by conventional techniques OR
- 10 mm or greater by spiral CT scan
- Must have received one (and only one) prior chemotherapy regimen for advanced or metastatic disease
- No clinical signs of brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Absolute neutrophil count at least 2,000/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase and transaminases no greater than 2.5 times ULN (no greater than 5 times ULN with liver metastases)
Renal:
- Creatinine no greater than 1.7 mg/dL
Cardiovascular:
- Normal cardiac function
- No ischemic heart disease within the past 6 months
- Normal 12 lead ECG
Other:
- No prior gastrectomy or any gastrointestinal disease that may impair absorption of SCH 66336
- No unstable systemic disease
- No active uncontrolled infection
- No psychological, familial, sociological, or geographical condition that would preclude study
- No prior or concurrent other malignancy except cone biopsied carcinoma in situ of the cervix or adequately treated basal or squamous cell skin cancer
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
- No prior farnesyl protein transferase inhibitors or gemcitabine
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Surgery:
- At least 2 weeks since prior major surgery
Other:
- No other concurrent anticancer agents
- No other concurrent investigational therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006351
Locations
| Netherlands | |
| University Medical Center Nijmegen | |
| Nijmegen, Netherlands, 6500 | |
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
| 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00006351 History of Changes |
| Other Study ID Numbers: | EORTC-16997, EORTC-16997, EORTC-GU-16997, EORTC-PAMM-16997 |
| Study First Received: | October 4, 2000 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
recurrent bladder cancer stage IV bladder cancer transitional cell carcinoma of the bladder recurrent urethral cancer anterior urethral cancer |
posterior urethral cancer urethral cancer associated with invasive bladder cancer metastatic transitional cell cancer of the renal pelvis and ureter recurrent transitional cell cancer of the renal pelvis and ureter |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Urethral Neoplasms Carcinoma, Transitional Cell Kidney Neoplasms Ureteral Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Urethral Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Kidney Diseases Ureteral Diseases Gemcitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013