R-Flurbiprofen in Treating Patients With Localized Prostate Cancer at Risk of Recurrence

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Myrexis Inc.

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

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• WBC at least 2,500/mm^3

• Platelet count at least 100,000/mm^3

• 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

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