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R115777 in Treating Patients With Progressive, Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on R115777 in Treating Patients With Progressive, Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. R115777 in Treating Patients With Progressive, Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy Clinical research trials and R115777 in Treating Patients With Progressive, Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like R115777 in Treating Patients With Progressive, Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy. R115777 in Treating Patients With Progressive, Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a R115777 in Treating Patients With Progressive, Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy clinical trial. Subjects typically recieve the finest healthcare available for their R115777 in Treating Patients With Progressive, Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > R115777 in Treating Patients With Progressive, Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy  R115777 in Treating Patients With Progressive, Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
R115777 in Treating Patients With Progressive, Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
For Condition: adenocarcinoma of the prostate,stage 4 prostate cancer,recurrent prostate cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Fox Chase Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GaryHudes, Study Chair, Fox Chase Cancer Center
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Additional Information:
Study ID Numbers: CDR0000067866; FCC-RRC-56-99,NCI-20,FCCC-99031
Study Start Date: April 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005848
Other Recurrent Prostate Cancer Studies:
1. Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer
2. Bortezomib and Mitoxantrone in Treating Patients With Advanced or Metastatic Androgen-Independent Prostate Cancer
3. Vaccine Therapy in Treating Patients With Advanced Prostate Cancer
4. Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
5. Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases
Related Studies:
Other recurrent prostate cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
R115777 in Treating Patients With Progressive, Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
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