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Phase IIB Randomized Study of R-Flurbiprofen in Patients With Localized Adenocarcinoma of the Prostate With an Intermediate or High Risk of Recurrence and Rising Prostate-Specific Antigen After Radiotherapy Alone, Prostatectomy Alone, or Both Radiotherapy and Prostatectomy
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Trial Contact Information Registry Information
Alternate Title
R-Flurbiprofen in Treating Patients With Localized Prostate Cancer at Risk of
Recurrence
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
---|
Phase II | Treatment | Closed | 18 and over | MYRIAD-MPR-7869-001 NCT00045123 |
Objectives - Determine the effect of R-flurbiprofen on time to systemic disease progression evaluated over a minimum of 3 years in patients with localized adenocarcinoma of the prostate with an intermediate or high risk of recurrence and rising prostate-specific antigen (PSA) levels after radiotherapy alone, prostatectomy alone, or both radiotherapy and prostatectomy.
- Determine the effect of this drug on the change in serum PSA levels over time prior to androgen-deprivation therapy (ADT) in these patients.
- Determine the effect of this drug on the time of initiation of ADT in these patients.
- Determine the effect of this drug on the number of patients requiring ADT.
- Determine the safety of this drug in these patients.
- Determine the population pharmacokinetics of R-flurbiprofen and bioinversion of R-ToS in this patient population.
- Determine the number of patients with systemic disease progression at the end of the study.
- Determine the time to clinical disease progression in patients treated with this drug.
- Determine the time to prostate cancer-related mortality and time to all cause mortality in patients treated with this drug.
Entry Criteria Disease Characteristics:
- Histologically confirmed localized adenocarcinoma of the prostate (from a
pre-operative core biopsy, surgical specimen, or post-therapy core biopsy)
- Gleason score 5-10 at diagnosis (the highest score is used if multiple
scores are available)
- Must have undergone 1 of the following curative treatment strategies:
- Radical prostatectomy
- Not a candidate for radiotherapy
- Radical prostatectomy followed by radiotherapy at the time of surgery
or any time thereafter
- Radiotherapy of the prostate and/or surrounding structures by external beam
radiotherapy (EBRT), brachytherapy (BT), or a combination of EBRT and BT
- Must have 3 consecutive rising prostate-specific antigen (PSA) measurements OR meets slope criteria
- Biochemical failure, meeting 1 of the following criteria:
- PSA at least 0.2 ng/mL post radical prostatectomy
- PSA greater than 1.5 ng/mL after radiotherapy or appropriate calculated slope
- Testosterone at least 100 ng/mL
- No rise in PSA with concurrent clinically active prostatitis
- No metastatic prostate cancer
- PSA no greater than 20.0 ng/mL
Prior/Concurrent Therapy:
Biologic therapy - No concurrent biologic therapy
Chemotherapy - More than 5 years since prior cytotoxic chemotherapy for other malignant disease
- No prior cytotoxic chemotherapy for prostate cancer
- No concurrent chemotherapy
Endocrine therapy - More than 9 months since prior androgen-deprivation therapy other than as
cytoreductive therapy (neoadjuvantly or adjuvantly for less than 9 months)
with the intent to cure
- More than 3 months since prior cyproterone, finasteride, diethylstilbestrol,
megestrol, or other hormonally active (antiandrogen or antiprostate)
therapies
Radiotherapy - See Disease Characteristics
- No prior strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium, or
other radioisotope materials for palliative intent or metastasis
intervention
- Concurrent iodine I 125 or palladium Pd 103 for primary brachytherapy with
curative intent allowed
Surgery - See Disease Characteristics
- More than 8 weeks since prior major surgery and recovered
- No prior orchiectomy
Other - More than 1 month since prior PC-SPES
- More than 1 month since prior investigational agents or devices (6 months for
other investigational therapy for prostate cancer)
- No prior bisphosphonates (e.g., pamidronate, alendronate, or clodronate) for
palliative intent or metastasis intervention
- At least 2 months since prior chronic
non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (COX-2)-specific inhibitors (e.g.,
celecoxib or rofecoxib), administered for more than 7 days per month
- No concurrent CYP2C9 inhibitor or substrates, including but not limited to the following:
- Phenytoin
- Fluvastatin
- Amiodarone
- Fluconazole
- Acenocoumarol
- Diclofenac
- No concurrent ketoconazole
- No concurrent antiretroviral therapy for HIV-positive patients
- Concurrent cardioprotective aspirin up to 100 mg once daily allowed
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - WBC at least 2,500/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 10 g/dL
Hepatic - Bilirubin no greater than 1.5 mg/dL
- AST or ALT no greater than 2 times upper limit of normal
Renal - Creatinine no greater than 2.0 mg/dL
Cardiovascular - No uncontrolled cardiac conditions
- No New York Heart Association class III or IV heart disease
Gastrointestinal - No active ulcer disease diagnosed within the past 3 months
-
No upper gastrointestinal bleed requiring a transfusion within the past 3
years
- No non-steroidal anti-inflammatory drug (NSAID)-associated ulcers within the past 5 years
Other - No known hypersensitivity to NSAIDs, including COX-2-specific inhibitors
(e.g., celecoxib or rofecoxib)
- No other malignancy within the past 5 years except basal cell or squamous cell skin cancer
-
No active systemic infections
- No other serious uncontrolled medical condition
- No dementia or altered mental status
Expected Enrollment Approximately 390 patients (130 per treatment arm) will be accrued for this study within 3 years. 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. - Arm I: Patients receive oral low-dose R-flurbiprofen twice daily.
- Arm II: Patients receive oral high-dose R-flurbiprofen twice daily.
- Arm III: Patients receive oral placebo twice daily.
In all arms, treatment continues for up to 5.5 years (66 months) in the absence of disease progression or unacceptable toxicity. Patients who demonstrate increased prostate-specific antigen without objective disease progression and require androgen-deprivation therapy (ADT) continue receiving R-flurbiprofen. Patients who develop local recurrence or systemic disease may withdraw from study and receive additional therapy off study.
Trial Contact Information
Trial Lead Organizations Myriad Pharmaceuticals, Incorporated | | | Sheron Bass, RN, MS, Study coordinator | | | |
Registry Information | | 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 | | Trial Start Date | | 2002-02-05 | | Registered in ClinicalTrials.gov | | NCT00045123 | | Date Submitted to PDQ | | 2002-06-18 | | Information Last Verified | | 2004-02-23 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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