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Sponsored by: |
Myriad Pharmaceuticals |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00045123 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. R-flurbiprofen may be effective in delaying the recurrence of localized prostate cancer.
PURPOSE: Randomized phase II trial to study the effectiveness of R-flurbiprofen in treating patients who have localized prostate cancer at risk of recurrence following radiation therapy and/or prostatectomy.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: R-flurbiprofen Procedure: adjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | Phase IIB, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Efficacy of MPC-7869 in Delaying the Systemic Progression of Prostate Cancer in Patients With Intermediate to High Risk of Recurrence With Rising PSA Levels After Prostatectomy, Prostatectomy and Radiotherapy or Radiotherapy Alone for Localized Disease |
Study Start Date: | February 2002 |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to risk of recurrence based on Gleason score at diagnosis (5-7 vs 8-10). Patients are randomized to 1 of 3 treatment arms.
PROJECTED ACCRUAL: Approximately 390 patients (130 per treatment arm) will be accrued for this study within 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must have undergone 1 of the following curative treatment strategies:
Radical prostatectomy
Biochemical failure, meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent CYP2C9 inhibitor or substrates, including but not limited to the following:
Investigator: | Sheron B. Bass, RN, MS | Myriad Pharmaceuticals |
Study ID Numbers: | CDR0000256371, MYRIAD-MPR-7869-001 |
Study First Received: | September 6, 2002 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00045123 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate recurrent prostate cancer |
Anti-Inflammatory Agents Genital Neoplasms, Male Prostatic Diseases Cyclooxygenase Inhibitors Disease Progression Adjuvants, Immunologic Urogenital Neoplasms Genital Diseases, Male Recurrence |
Analgesics, Non-Narcotic Flurbiprofen Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Adenocarcinoma Prostatic Neoplasms |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Genital Neoplasms, Male Prostatic Diseases Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Urogenital Neoplasms Genital Diseases, Male Pharmacologic Actions Neoplasms |
Neoplasms by Site Flurbiprofen Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Prostatic Neoplasms |