Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 27
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21.

Phase II: Patients receive ABT-751 twice daily

Interventions: intervention 1: ABT-751
Intervention descriptions: intervention 1: Phase I:

Cohort \| Number of Patients \|Dose (mg) ABT-751 (BID)

* -1 \| 3-6 \|100 mg BID
* 1 \| 3-6 \|125 mg BID
* 2 \| 3-6 \|150 mg BID
* 3 \| 3-6 \|175 mg BID
* 4 \| 3-6 \|200 mg BID

Phase II:

Patients receive ABT-751 at 125mg po BID for 7 days on, 7 days off (X2) for a 28 day cycle

Protocol document: