BMS-275291 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

NCT00040755 | Completed Phase 2

• 5 other identifiers: NCI-2013-00041PHII-32N01CM17101N01CM17102CDR0000069402
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

BMS-275291 may stop the growth of prostate cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth. Randomized phase II trial to study the effectiveness of BMS-275291 in treating patients who have prostate cancer that has not responded to hormone therapy

Conditions

Adenocarcinoma of the Prostate; Bone Metastases; Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  4 months

Secondary Outcomes (2)

• PFS

  6 months

• Toxicities assessed for type, severity, time or onset, time of resolution, and the probability of association with the study regiment using National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2.0

  Up to 4 years

Study Arms (2)

Arm I (rebimastat once daily)

EXPERIMENTAL

Patients receive oral BMS-275291 once daily on days 1-28. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR receive 2 additional courses beyond CR.

Drug: rebimastat; Other: laboratory biomarker analysis

Arm II (rebimastat twice daily)

EXPERIMENTAL

Patients receive oral BMS-275291 twice daily on days 1-28. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR receive 2 additional courses beyond CR.

Drug: rebimastat; Other: laboratory biomarker analysis

Interventions

rebimastat DRUG

Given orally

Also known as: BMS-275291, D2163

Arm I (rebimastat once daily); Arm II (rebimastat twice daily)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (rebimastat once daily); Arm II (rebimastat twice daily)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must have a histologic diagnosis of adenocarcinoma of the prostate stage D2 that is unresponsive or refractory to hormone therapy; patients must have metastatic prostate cancer deemed to be hormone refractory by one or more of the following (despite androgen deprivation and anti-androgen withdrawal when applicable):
• Progression or unidimensionally measurable disease assessed within 28 days prior to initial administration of drug
• Progression of evaluable but not measurable disease assessed within 28 days prior to initial administration of drug for PSA evaluation and within 42 days for imaging studies (e.g. bone scans)
• Rising PSA, defined as at least two consecutive rises in PSA to be documented over a reference value; the first rising PSA should be taken at least 7 days after the reference value; a third confirmatory PSA measure should be greater than the second measure, and it must be obtained at least 7 days after the 2nd measure; if this is not the case, a fourth PSA is required to be taken and be greater than the second measure
• All patients must have pre-study PSA within 28 days prior to initial administration of drug
• Patients who have measurable disease must have mad x-rays, scans or physical examinations used for tumor measurement completed within 28 days prior to initial administration of drug; patients must have non-measurable disease within 28 days (for PSA level) or 42 days (for imaging studies) prior to initial administration of drug; soft tissue disease that has been radiated within the two months prior to registration is not assessable as measurable disease; soft tissue disease that has been radiated two or more months prior to registration is assessable as measurable disease provided that the lesion has progressed following radiation; as the biology of previously irradiated tumor may be different from non-irradiated tumors, patients must have at least one measurable lesion outside the previously irradiated region in order to be considered to have measurable disease
• Patients must have bone metastases as documented by x-ray, bone scan, MRI, or biopsy
• Patients must agree to have serum and urine samples taken approximately every eight weeks and submitted for correlative studies
• All patients must have had a CT scan of the abdomen and pelvis within 28 days prior to initial administration of drug; bone scans must be performed within 42 days of initial drug administration
• Patients must have been surgically or medically castrated; if the method of castration was LHRH agonists (leuprolide or goserelin), then the patient must be willing to continue the use of LHRH agonists
• If the patient has been treated with non-steroidal anti-androgens (flutamide, bicalutamide or nilutamide) or other hormonal treatment (such as ketoconazole), these agents must have been stopped at least 28 days prior to enrollment for flutamide or ketoconazole, and at least 42 days prior to enrollment for bicalutamide or nilutamide; and the patients must have demonstrated progression of disease since the agents were suspended
• Prior radiation therapy is allowed; at least 21 days must have elapsed since the completion of radiation therapy, and the patient must have recovered from the side effects of the radiation; if the patient has received strontium 89 or samarium 153, at least three months must have elapsed since completion of therapy, and the patient must have recovered from side effects of therapy, and the AGC and platelets must meet the parameters specified
• No more than one prior chemotherapy regimen is allowed; at least 3 weeks must have elapsed since the completion of the chemotherapy, and the patient must have recovered from the side effects of the therapy
• Patients must have a Karnofsky performance status of 60-100%
• Platelet count of \>= 100,000/uL

You may not qualify if:

• AGC \>= 1,500/uL

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

N-((2S)-2-mercapto-1-oxo-4-(3,4,4- trimethyl-2,5-dioxo-1-imidazolidinyl)butyl)-L-leucyl-N,3- dimethyl-L-Valinamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Primo Lara

  UC Davis Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2002
• First Posted: January 27, 2003
• Study Start: May 1, 2002
• Primary Completion: July 1, 2006
• Last Updated: February 1, 2013

Record last verified: 2013-01

Locations

US (1)