BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

• Status: Completed
• Trial end date: 2006-04-01
• 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.

PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have prostate cancer that has not responded to hormone therapy.

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

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• Stage D1 or D2 disease (T4, N0, M0; any T, N1-3, M0; or any T, any N, M1)

• Unresponsive or refractory to prior hormonal therapy by at least 1 of the following:

• Progression of unidimensionally measurable lesion outside of a prior radiation port

• Progression of non-measurable disease (e.g., bone scan)

• Rising prostate-specific antigen (PSA) on at least 2 consecutive measurements taken at least 7 days apart

• PSA at least 5 ng/mL

• No brain metastases

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute granulocyte count at least 1,500/mm^3

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

Hepatic:

• Bilirubin no greater than upper limit of normal (ULN)

• SGOT or SGPT no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 2.0 mg/dL OR

• Creatinine clearance at least 40 mL/min

Other:

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

• No other concurrent significant active illness that would preclude study participation

• Recovered from major infections

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 28 days since prior biologic therapy and recovered

• No more than 1 prior biologic (non-cytotoxic) therapy

• No concurrent biological response modifiers

Chemotherapy:

• No prior chemotherapy for this disease

• No other concurrent chemotherapy

Endocrine therapy:

• See Disease Characteristics

• At least 28 days since prior flutamide or ketoconazole

• At least 42 days since prior bicalutamide or nilutamide

• No concurrent hormonal therapy, except luteinizing hormone-releasing hormone therapy

• No concurrent corticosteroids

Radiotherapy:

• See Disease Characteristics

• Prior radiotherapy to less than 30% of bone marrow allowed

• No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium

• At least 28 days since prior radiotherapy and recovered

• No concurrent radiotherapy

Surgery:

• Recovered from prior surgery

• Prior orchiectomy allowed

Other:

• No concurrent unconventional therapy (e.g., St. John's Wort, PC-SPES, or other herbal remedy for prostate cancer)

• Not planning to begin bisphosphonate therapy (patients already receiving bisphosphonates are eligible provided they have progressive disease)