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

NCT00471718 | Terminated Phase 1 Results DMC

• 2 other identifiers: VICC URO 0426VU-VICC-URO-0426
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage IV prostate cancer; recurrent prostate cancer

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose (MTD)

  MTD is determined by the 3+3 study design, in which patients are enrolled in cohorts of 3. In any dose cohort, if 1 patient of 3 experience dose-limiting toxicity (DLT), three additional patients will be enrolled at the same dose level. Whenever \>=2 of 6 subjects experience a DLT, then the maximum tolerated dose (MTD) has been exceeded. The MTD is generally one dose below that at which DLT occurs in \>= 2 of 6 subjects in any given cohort.

  up to four weeks

• Number of Patients Who Demonstrated Treatment Effectiveness Based on Prostate Specific Antigen (PSA) Response in Non-measurable Disease

  Patients with a minimum 50% decline in PSA from pre-treatment baseline, confirmed by a second PSA 4 or more weeks later, measured in nanograms per milliliter of blood.

  after four weeks

Secondary Outcomes (4)

• Number of Patients With Objective Response (CR & PR) by RECIST

  after four weeks

• Median Time to Tumor Progression

  date on study to date of progression

• Overall Survival

  date on study to date of death from any cause

• Safety Profile Based on Number of Patients With Worst Grade Toxicities

  at 30 days after final treatment dose

Study Arms (1)

Phase I/II: Chemotherapy ABT-751

EXPERIMENTAL

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

Drug: ABT-751

Interventions

ABT-751 DRUG

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

Phase I/II: Chemotherapy ABT-751

Eligibility Criteria

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

You may qualify if:

• 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
• The patient must have adequate hematologic, renal and hepatic function as follows:
• Hematologic: ANC \> 1200/mm3; hemoglobin \> 9.0 g/dl; platelets \> 100,000/mm3
• Renal: serum creatinine \< 2.0 mg/dL
• Hepatic: bilirubin \< 2.5 mg/dL; AST and ALT \< 2.5X upper limit of normal (ULN); \< 5X ULN for patients with hepatic metastases
• Sexually-active patients must use a contraceptive method deemed acceptable by the investigator while in the study and for up to 3 months following completion of therapy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

ABT751

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jeff Sosman, MD
• Organization: Vanderbilt-Ingram Cancer Center

jeff.sosman@vanderbilt.edu

615-936-3048

Study Officials

• Jeff Sosman, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine; Director, Melanoma and Tumor Immunotherapy

Study Record Dates

• First Submitted: May 8, 2007
• First Posted: May 10, 2007
• Study Start: January 1, 2004
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: July 11, 2012
• Results First Posted: June 27, 2012

Record last verified: 2012-06

Locations

US (1)