BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: ixabepilone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Study Start Date: | June 2001 |
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.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Show 28 Study Locations| Study Chair: | Maha Hadi A. Hussain, MD | University of Michigan Cancer Center |
| Investigator: | Primo N. Lara, MD | University of California, Davis |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00016393 History of Changes |
| Other Study ID Numbers: | CDR0000068629, SWOG-S0111 |
| Study First Received: | May 6, 2001 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013