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

A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) (IND 59699) Administered Every 21 Days in Patients With Hormone Refractory Prostate Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00016393
Enrollment
Unknown
Registered
2003-01-27
Start date
2001-06-30
Completion date
2006-04-30
Last updated
2013-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

Brief 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.

Detailed description

OBJECTIVES: * Determine the prostate-specific antigen response to BMS-247550 in patients with hormone-refractory prostate cancer. * Determine the overall survival and progression-free survival rate in patients treated with this drug. * Determine the objective response rate (confirmed and unconfirmed complete and partial responses) in those patients with measurable disease treated with this drug. * Evaluate the qualitative and quantitative toxic effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 25-45 patients will be accrued for this study within 5-9 months.

Interventions

DRUGixabepilone

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
SWOG Cancer Research Network
Lead SponsorNETWORK

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

Inclusion 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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026