Expired Study
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Cleveland, Ohio 44195


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

FCCC-99031


NCT ID:

NCT00005848


Secondary ID:

CDR0000067866


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Fox Chase Cancer Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, I


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

7


Enrollment Type:

Actual


Overall Contact Information

Official Name:Gary R. Hudes, MD
Study Chair
Fox Chase Cancer Center

Study Dates

Start Date:April 2000
Completion Date:May 2007
Completion Type:Actual
Primary Completion Date:May 2007
Primary Completion Type:Actual
Verification Date:July 2013
Last Changed Date:July 10, 2013
First Received Date:June 2, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:chemotherapy
Intervention Type:Drug
Name:tipifarnib

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Fox Chase Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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