R115777 in Treating Patients With Progressive, Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

NCT ID: NCT00005848

Last Updated: 2013-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-04-30
• Study Completion Date: 2007-05-31

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have progressive, metastatic prostate cancer that has not responded to hormone therapy.

Detailed Description

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 months.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT

Interventions

chemotherapy

Intervention Type: DRUG

tipifarnib

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary R. Hudes, MD

Role: STUDY_CHAIR

Fox Chase Cancer Center

Locations

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

CDR0000067866

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-20

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

FCCC-99031

Identifier Type: -

Identifier Source: org_study_id