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| Sponsor: | Myrexis Inc. |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00045123 |
Purpose
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: tarenflurbil Procedure: adjuvant therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
| 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.
Eligibility| 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:
Contacts and Locations
Show 58 Study Locations| Investigator: | Sheron B. Bass, RN, MS | Myrexis Inc. |
More Information
| ClinicalTrials.gov Identifier: | NCT00045123 History of Changes |
| Obsolete Identifiers: | NCT00043251 |
| Other Study ID Numbers: | CDR0000256371, MYRIAD-MPR-7869-001 |
| Study First Received: | September 6, 2002 |
| Last Updated: | October 28, 2010 |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the prostate recurrent prostate cancer |
|
Prostatic Neoplasms Recurrence Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases Disease Attributes Pathologic Processes |