SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Completed

CT.gov ID

NCT00006351

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

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

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

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

Study Start Date :

Jun 1, 2000

Actual Primary Completion Date :

Dec 1, 2001

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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