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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


Phase 2
N/A
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.

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)

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Maha Hadi A. Hussain, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068629

NCT ID:

NCT00016393

Start Date:

June 2001

Completion Date:

April 2006

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
Harrington Cancer CenterAmarillo, Texas  79106
CCOP - Grand RapidsGrand Rapids, Michigan  49503
CCOP - Scott and White HospitalTemple, Texas  76508
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
University of California Davis Cancer CenterSacramento, California  95817
Oregon Cancer InstitutePortland, Oregon  97201-3098
Danville Radiation Therapy CenterMemphis, Tennessee  38104
Veterans Affairs Medical Center - AmarilloAmarillo, Texas  79106
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642