S0421, Docetaxel and Prednisone With or Without Atrasentan in Treating Patients With Stage IV Prostate Cancer and Bone Metastases That Did Not Respond to Previous Hormone Therapy

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, prednisone, and atrasentan work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether docetaxel, prednisone, and atrasentan are more effective than docetaxel and prednisone in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying docetaxel, prednisone, and atrasentan to see how well they work compared to docetaxel and prednisone in treating patients with stage IV prostate cancer and bone metastases that did not respond to previous hormone therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Atrasentan; Docetaxel; Hormones; Prednisone

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• Stage IV disease (any T, any N, M1b)

• Evidence of bone metastases by bone scan or MRI

• Measurable or nonmeasurable disease

• Soft tissue disease that has been irradiated within the past 2 months is not assessable as measurable disease

• Hormone-refractory disease despite androgen deprivation and antiandrogen withdrawal, as defined by 1 of the following criteria:

• Prostate-specific antigen (PSA) progression, defined as 3 consecutive rising PSA levels* taken ≥ 1 week apart

• PSA ≥ 5 ng/mL NOTE: *If the third confirmatory PSA level is < the second level, the patient is considered eligible provided a fourth PSA level is > the second level

• Progression of measurable disease

• Progression of nonmeasurable disease by bone scan

• Must have undergone surgical or medical (e.g., luteinizing hormone-releasing hormone [LHRH] agonist [e.g., leuprolide or goserelin] or LHRH antagonist therapy) castration

• Patients who have undergone medical castration must continue LHRH agonist or antagonist therapy during study treatment

• Must have completed 12 courses of blinding protocol treatment (atrasentan/placebo) AND stopped docetaxel for any reason (including completion of 12 courses) other than progressive disease

• No symptomatic pleural effusion

• No third space fluid accumulation (e.g., ascites)

• No prior or concurrent brain metastases

• Patients with clinical evidence of brain metastases must have a negative brain CT scan or MRI within the past 8 weeks

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-3* NOTE: For a performance status of 3, the cause must be due to pain secondary to bone metastases

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Fertile patients must use effective contraception

• Able to take oral medication without crushing, dissolving, or chewing tablets

• No major infection

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer in complete remission

• No symptomatic sensory neuropathy ≥ grade 2

• No history of hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80

• No other significant, active medical illness that would preclude study treatment or survival

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No more than 1 prior systemic vaccine or biologic therapy

• At least 4 weeks since prior vaccine or biologic therapy and recovered

• No concurrent biological response modifiers

• No concurrent prophylactic colony-stimulating factors

Chemotherapy

• More than 2 years since prior adjuvant therapy with a single non-taxane-containing cytotoxic regimen

• No prior cytotoxic chemotherapy for metastatic prostate cancer

• No other concurrent chemotherapy

Endocrine therapy

• See Disease Characteristics

• At least 6 weeks since prior bicalutamide or nilutamide AND has subsequent disease progression

• At least 4 weeks since prior flutamide or ketoconazole AND has subsequent disease progression

• Prior or concurrent megestrol for treatment of hot flashes allowed

• No other concurrent corticosteroid or hormonal therapy unless continuing luteinizing hormone-releasing hormone treatment and/or bisphosphonate therapy

Radiotherapy

• See Disease Characteristics

• Prior samarium allowed

• At least 3 weeks since prior radiotherapy and recovered

• No prior radiotherapy to ≥ 30% of the bone marrow

• No prior strontium

• No concurrent radiotherapy

Surgery

• See Disease Characteristics

• At least 3 weeks since prior surgery and recovered

Other

• More than 4 weeks since prior investigational drugs

• Concurrent bisphosphonates allowed provided therapy is started prior to study entry, dose is maintained during the first 12 weeks of study treatment, and patient meets criteria for disease progression

• No initiation of bisphosphonates during the first 12 weeks of study treatment

• No concurrent herbal medications or food supplements (e.g., PC-SPES, saw palmetto, Hypericum perforatum [St. John's wort])

• Concurrent daily vitamins and calcium supplements allowed

• At least 14 days since prior and no concurrent administration of any of the following:

• Antibiotics (e.g., clarithromycin, erythromycin, troleandomycin, rifampin, rifabutin, and rifapentine)

• Antifungals (e.g., itraconazole, ketoconazole, fluconazole [doses > 200 mg/day], and voriconazole)

• Antidepressants (e.g., nefazodone and fluvoxamine)

• Calcium channel blockers (e.g., verapamil, diltiazem)

• Miscellaneous (e.g., amiodarone [no use within 6 months prior to study entry], grapefruit juice, bitter orange, or modafinil)

• Anticonvulsants (e.g., phenytoin, carbamazepine, phenobarbital, and oxcarbazepine)

• Antibiotics (e.g., rifampin, rifabutin, and rifapentine)