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Phase II Trial of R115777 (NSC 702818) an Inhibitor of Farnesyl Protein Transferase, in Patients With Hormone Refractory Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

Phase II Trial of R115777 (NSC 702818) an Inhibitor of Farnesyl Protein Transferase, in Patients With Hormone Refractory Prostate Cancer

OBJECTIVES: I. Determine whether R115777 has any antitumor activity in patients with
progressive, metastatic, hormone refractory prostate cancer. II. Determine the safety and
pharmacokinetics of this regimen in this patient population.

OUTLINE: Patients receive oral R115777 every 12 hours on days 1-21. Courses repeat every 4
weeks in the absence of disease progression or unacceptable toxicity. Patients are followed
every 3 months.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 10-16

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the prostate with
evidence of bone, pelvic, lymph node, liver, or lung metastases Radiologic evidence of
hydronephrosis alone does not constitute evidence of metastatic disease Patients with bone
metastases only (i.e., no measurable soft tissue disease) must have PSA level of at least
5 ng/mL Prior bilateral orchiectomy or other prior primary hormonal therapy (e.g.,
estrogen therapy, LHRH agonist with or without flutamide or bicalutamide) with evidence of
treatment failure Patients without prior orchiectomy must continue on LHRH agonist therapy
At least 4 weeks since prior flutamide (at least 6 weeks since prior bicalutamide or
nilutamide) with continued evidence of progressive disease (i.e., increasing PSA) Must
have evidence of progressive disease, defined by any one or more of the following after
completion of primary hormonal therapy (which must include either orchiectomy or LHRH
agonist therapy): Rising PSA, defined by at least 50% increase above nadir value achieved
on prior therapy Increase confirmed by a second measurement obtained a minimum of 1 week
following the index measurement, and confirmed by a third measurement if the second value
is less than the first increase One of more new bone metastases on radionuclide bone scan
or x-ray film New or enlarging soft tissue metastases Disease related symptoms such as
pain not required Ineligible if an elevated serum acid phosphatase or PSA level is the
only evidence of disease No history of brain metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy:
Not specified Hematopoietic: WBC at least 4,000/mm3 Granulocyte count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or
SGPT no greater than 2 times normal Renal: Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 50 mL/min Cardiovascular: No active angina pectoris No New
York Heart Association class II-IV heart disease No myocardial infarction within the past
6 months Other: Fertile patients must use effective contraception during and for 3 months
after study No other malignancy within the past 3 years No serious concurrent medical
illness or active infection that would preclude study chemotherapy No allergy or
sensitivity to imidazole antifungal medications (e.g., fluconazole, ketoconazole,
miconazole, itraconazole, and clotrimazole)

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent prophylactic filgrastim (G-CSF),
sargramostim (GM-CSF), or thrombopoietin Chemotherapy: No prior chemotherapy Endocrine
therapy: See Disease Characteristics No other concurrent hormonal therapies (e.g.,
antiandrogens or megestrol acetate) except adrenal replacement dose corticosteroids
Radiotherapy: No prior strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium,
or other radioisotope therapies At least 4 weeks since other prior radiotherapy and
recovered Surgery: See Disease Characteristics Other: At least 1 week since prior and no
concurrent cholesterol lowering medications (e.g., lovastatin, simvastatin) At least 1
week since prior and no concurrent proton pump inhibitors (e.g., omeprazole, lansoprazole)
Concurrent H2 receptor antagonists or antacids allowed at least 2 hours following
administration of R115777 No concurrent bisphosphonates (e.g., pamidronate, zoledronate)
No concurrent imidazole antifungal medications

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Gary R. Hudes, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:




Start Date:

April 2000

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms



Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195