Know Cancer

or
forgot password

Phase II Study on SCH 66336 (Farnesyl Protein Transferase Inhibitor) and Gemcitabine as Second Line Treatment in Advanced Metastatic Urothelial Cancer - EORTC Study 16997


Phase 2
18 Years
N/A
Not Enrolling
Both
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer

Thank you

Trial Information

Phase II Study on SCH 66336 (Farnesyl Protein Transferase Inhibitor) and Gemcitabine as Second Line Treatment in Advanced Metastatic Urothelial Cancer - EORTC Study 16997


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ronald De Wit, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Authority:

United States: Federal Government

Study ID:

EORTC-16997

NCT ID:

NCT00006351

Start Date:

June 2000

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Urethral Cancer
  • 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
  • Urinary Bladder Neoplasms
  • Urethral Neoplasms
  • Carcinoma, Transitional Cell
  • Kidney Neoplasms
  • Ureteral Neoplasms
  • Urologic Neoplasms

Name

Location