Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00040755
Other study ID # NCI-2013-00041
Secondary ID PHII-32N01CM1710
Status Completed
Phase Phase 2
First received July 8, 2002
Last updated January 31, 2013
Start date May 2002

Study information

Verified date January 2013
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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


Description:

PRIMARY OBJECTIVES:

I. To assess the time to disease progression in patients with hormone-refractory prostate cancer treated with two different doses of BMS-275291.

SECONDARY OBJECTIVES:

I. To assess the overall survival of patients with hormone-refractory prostate cancer treated with two different doses of BMS-275291.

II. To assess the rate of response to BMS-275291, using both PSA and measurable disease.

III. To evaluate the qualitative and quantitative toxic effects of this agent in this patient population.

IV. To investigate the correlation of tumor response with changes in the levels of serum osteocalcin, alkaline phosphatase, procollagen I carboxy-terminal propeptide (PICP), procollagen I amino-terminal propeptide (PINP), and N-telopeptide; and the correlation of tumor response with changes in the levels of urine pyridinoline and deoxypyridinoline.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Gleason score (2-4 vs 5-7 vs 8-10), PSA level (less than 10 ng/mL vs 10-50 ng/mL vs 51-100 ng/mL vs more than 100 ng/mL), and concurrent bisphosphonate therapy (yes vs no). Patients are randomized to one of two treatment arms.

ARM I: Patients receive oral BMS-275291 once daily on days 1-28.

ARM II: Patients receive oral BMS-275291 twice daily on days 1-28.

In both arms, treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR.

Patients are followed until death.

PROJECTED ACCRUAL: A total of 24-68 patients (12-34 per treatment arm) will be accrued for this study within 5-14 months.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date
Est. primary completion date July 2006
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria:

- 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

- Serum bilirubin =< the institutional upper limit of normal

- SGOT and SGPT =< 2 x institutional upper limit of normal

- Serum creatinine =< 1.5 mg/dl or a calculated creatinine clearance of >= 60mL/min

- No other chemotherapeutic agents, biological response modifiers, radiation therapy, corticosteroid or hormonal concomitant therapy (other than continuing LHRH treatment) may be given during protocol treatment; bisphosphonates may not be given during protocol treatment except under the circumstances outlined; no unconventional therapy (e.g. St. John's Wort, PC-SPES, or any other herbal remedies taken for the purpose of treating prostate cancer) may be given during protocol treatment

- Patients must not be planning to begin bisphosphonates; patients already receiving bisphosphonates may continue and are eligible provided that they have progressive disease documented while on bisphosphonate therapy

- Patients with a history of brain metastases, or who currently have treated or untreated brain metastases, are not eligible

- Patients must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have significant active concurrent other medical illness precluding protocol treatment

- Men of reproductive potential must agree to use an effective contraceptive method

- No prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ carcinoma of any site, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years

- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria:

- AGC >= 1,500/uL

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
rebimastat
Given orally
Other:
laboratory biomarker analysis
Correlative studies

Locations

Country Name City State
United States UC Davis Comprehensive Cancer Center Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression free survival (PFS) 4 months No
Secondary PFS 6 months No
Secondary 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 Yes
See also
  Status Clinical Trial Phase
Terminated NCT03986593 - Cryoablation of Bone Metastases From Endocrine Tumors N/A
Active, not recruiting NCT01996046 - FDG PET/CT in Breast Cancer Bone Mets
Completed NCT01358539 - Palliation: the Effect of Education on Pain Phase 3
Terminated NCT00981578 - ExAblate Conformal Bone System Treatment of Metastatic Bone Tumors for the Palliation of Pain N/A
Completed NCT00762346 - Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis Phase 4
Terminated NCT00757757 - A Phase I/II Open-label Study of MCS110 in Patients With Prostate Cancer and Bone Metastases Phase 1/Phase 2
Completed NCT00420433 - Bone Response in Metastatic Breast Cancer Involving Bones N/A
Completed NCT02826382 - Preliminary Evaluation of Uptake in Bone Metastases and Biodistribution of [68Ga]P15-041 Early Phase 1
Terminated NCT05301062 - A Research Called CREDIT Studies How Safe the Study Treatment Radium-223 is and How Well it Works in Chinese Men With Advanced Prostate Cancer That Has Spread to the Bones and Does Not Respond to Treatments for Lowering Testosterone Levels
Recruiting NCT06367491 - National Database of Bone Metastases
Completed NCT03223727 - Treatment Outcomes in a Non-study Population of Symptomatic mCRPC Patients Treated With Radium-223
Completed NCT00830180 - Open Label Extension In Cancer Patients Phase 2
Active, not recruiting NCT03305224 - The Combination Therapy With Ra-223 and Enzalutamide Phase 2
Withdrawn NCT04109937 - External Beam Radiation Therapy Post Surgery in Patients With Lower Extremity Bone Metastases Randomized Efficacy Trial N/A
Active, not recruiting NCT02880943 - Dose-finding, Safety and Efficacy Study of Radium-223 Dichloride (XOFIGO) in RCC Patients With Bone Metastases. (EIFFEL) Phase 1/Phase 2
Completed NCT01696760 - Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology N/A
Completed NCT00958477 - A Study to Determine the Safety, Tolerability, Pharmacokinetics and Dynamic Effects of Different Doses of the Study Drug EMD 525797 in Prostate Cancer Phase 1
Completed NCT03979118 - Exercise Prescription in Patients With Bone Metastases
Completed NCT03353090 - Double-bed SPECT/CT for Bone Scintigraphy in Initial Staging of Cancer Patients N/A
Recruiting NCT05167669 - Pain Relief in Symptomatic Bone Metastases With Adjuvant Hyperthermia MR Guided HIFU Early Phase 1