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ABT-751 in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

ABT-751 in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

A Phase1/2 Trial of ABT-751 in Patients With Advanced, Androgen-Independent Prostate Cancer

NCT00471718•Vanderbilt-Ingram Cancer Center

View on ClinicalTrials.gov

Summary

RATIONALE: Drugs used in chemotherapy, such as ABT-751, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I/II trial is studying the side effects and best dose of ABT-751 and to see how well it works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.

Detailed Description

OBJECTIVES: Primary * Evaluate the safety and efficacy of ABT-751 in patients with androgen-independent, hormone-refractory metastatic prostate cancer and determine the maximum tolerated dose (MTD) and optimal phase II dose of this drug in these patients. Secondary * Determine the objective response rate (partial and complete response) in patients with measurable disease treated with this drug. * Evaluate the effect of this drug on prostate-specific antigen (PSA) response in patients with nonmeasurable disease. * Determine the time to tumor progression in patients treated with this drug. * Determine survival of patients treated with this drug. * Determine the toxicity of this drug in these patients. OUTLINE: This is a phase I, dose-escalation study followed by a phase II study. * Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ABT-751 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 50 additional patients may be treated at the recommended phase II dose (RPTD) which is the dose level at the maximally administered dose. * Phase II: Patients receive ABT-751 at the MTD determined in phase I. After completion of study treatment, patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Patients at least 18 years of age.
•Patients must have histologically proven adenocarcinoma of the prostate gland.
•Patients must have metastatic disease (e.g. bone metastases, pelvic mass, nodal, liver or lung metastases), with evidence of radiographic progression (including bone scans observed during last treatment) or serologically -Patients with bone-only metastases (i.e. lacking soft tissue or visceral disease) must have a PSA level \> 10 ng/mls. Patients with soft tissue metastases and/or visceral disease must have either measurable disease OR a PSA level \> 10 ng/ml.
•Patients must have had prior treatment with bilateral orchiectomy or other primary hormonal therapy (e.g. LHRH therapy, estrogens, etc.) with evidence of treatment failure and simultaneous documentation of a castrate testosterone level (\< 50 ng/dL) NOTE: Patients who have not undergone bilateral orchiectomy must continue LHRH agonist therapy for the duration of this protocol unless this medically contraindicated.
•For patients previously treated with flutamide, nilutamide, or bicalutamide: patients must have discontinued flutamide or nilutamide \> 4 weeks prior to randomization (\> 6 weeks for bicalutamide) with no evidence of an anti-androgen withdrawal response (i.e. no decline in serum PSA and/or no improvement in baseline scans).
•Patients must have received prior therapy with docetaxel alone or in combination with either prednisone or estramustine. This therapy may have been given in a neoadjuvant, adjuvant or metastatic setting
•Patients must not have received radiotherapy \< 3 weeks prior to randomization. If patients have received prior radiotherapy to an evaluable lesion(s), there must be evidence of radiographic progression prior to entry.
•Patients must not have received prior Strontium 89, Samarium 153, or other therapeutic radioisotopes.
•Patients must have recovered from all systemic toxicities due to prior treatment for prostate cancer (does not include incontinence, impotence, etc. secondary to primary therapy)
•The patient must have an ECOG Performance Status of 0-1
+8 more criteria

Exclusion Criteria

•No active angina pectoris, uncontrolled hypertension, or known heart disease of New York Heart Association Class III-IV. Patients must not have a history of myocardial infarction, congestive cardiac failure (New York Heart Association Class 3), or coronary angioplasty/stenting \< 6 months prior to entry.
•No carcinomatous meningitis or brain metastases.
•Any investigational therapy within 4 weeks.
•No serious concurrent medical illness or active infection, which, in the opinion of the investigator, would jeopardize the ability of the patient to receive the chemotherapy outlined in this protocol with reasonable safety.
•Documented history of allergy to sulfa medications.
•Current colchicines treatment
•Greater than Grade 1 CTC neurology category findings (Appendix A).
•Prior treatment with more than 1 prior chemotherapy regimen.

Locations (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Key Dates

Start Date

January 1, 2004

Primary Completion Date

August 1, 2009

Completion Date

August 1, 2009

Last Updated

July 11, 2012

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

ABT-751

DRUG

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

View study

RECRUITINGPHASE2

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

NCT05691465

Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine Carcinoma+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ABT-751 in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC