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ABT-751 in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00471718
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: ABT-751
Phase I
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: ABT 751 E 7010
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase1/2 Trial of ABT-751 in Patients With Advanced, Androgen-Independent Prostate Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor response as assessed by RECIST criteria in patients with measurable or evaluable disease [ Designated as safety issue: No ]
  • Prostate-specific antigen (PSA) response as assessed by RECIST criteria in patients with nonmeasurable disease [ Designated as safety issue: No ]
  • Maximum tolerated dose [ Designated as safety issue: Yes ]
  • Recommended phase II dose [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to tumor progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Duration of overall response [ Designated as safety issue: No ]
  • Performance status [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]

Estimated Enrollment: 53
Study Start Date: October 2004
Estimated Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Evaluate the safety and efficacy of ABT-751 in patients with androgen-independent, hormone-refractory metastatic prostate cancer.
  • Determine the maximum tolerated dose (MTD) and optimal phase II dose of this drug in these patients.
  • 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.

Secondary

  • 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Metastatic disease (e.g., bone, pelvic mass, nodal, liver, or lung metastases) with evidence of disease progression by radiography (including bone scans observed during last treatment) or serology

      • Patients with bone-only metastases (i.e., lacking soft tissue or visceral disease) must have a prostate-specific antigen (PSA) level ≥ 10 ng/mL
      • Patients with soft tissue metastases and/or visceral disease must have measurable disease OR PSA ≥ 10 ng/mL
  • Underwent prior bilateral orchiectomy or other primary hormonal therapy (e.g., luteinizing hormone-releasing hormone [LHRH] therapy or estrogen) with subsequent evidence of treatment failure and simultaneous documentation of a castrate testosterone level ≤ 50 ng/dL

    • Patients who have not undergone bilateral orchiectomy must continue LHRH agonist therapy throughout study treatment unless medically contraindicated
  • Prior therapy with docetaxel alone or in combination with either prednisone or estramustine phosphate sodium required in a neoadjuvant, adjuvant, or metastatic setting
  • No brain metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • ANC ≥ 1,200/mm^3
  • Hemoglobin ≥ 9.0 g/dL
  • Platelet count ≥ 100,000/mm^3
  • Creatinine ≤ 2.0 mg/dL
  • Bilirubin < 2.5 mg/dL
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN for patients with hepatic metastases)
  • Fertile patients must use effective contraception during and for up to 3 months after completion of study therapy
  • Prior malignancy allowed provided patient was treated with curative intent and is free of disease for the time period considered appropriate for the specific malignancy
  • At least 6 months since prior myocardial infarction, New York Heart Association (NYHA) class III congestive cardiac failure, or coronary angioplasty/stenting
  • No active angina pectoris, uncontrolled hypertension, or NYHA class IV heart disease
  • No concurrent serious medical illness or active infection that would preclude study therapy
  • No allergy to sulfa medications
  • No neurology findings > grade 1

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from all prior therapy (not including incontinence or impotence secondary to primary therapy)
  • More than 3 weeks since prior radiotherapy

    • If patient has received prior radiotherapy to evaluable lesions, there must be evidence of radiographic progression prior to study entry
  • At least 4 weeks since prior flutamide or nilutamide (6 weeks for bicalutamide) with no evidence of an antiandrogen withdrawal response (i.e., no decline in serum PSA and/or no improvement in baseline scans)
  • More than 4 weeks since prior and no other concurrent investigational agents
  • No more than 1 prior chemotherapy regimen
  • No prior strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium, or other therapeutic radioisotopes
  • Concurrent bisphosphonate therapy allowed provided therapy was initiated at least 4 weeks prior to study entry
  • No concurrent colchicines
  • No other concurrent anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471718

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Study Chair: Bruce J. Roth, MD Vanderbilt-Ingram Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: Vanderbilt-Ingram Cancer Center ( Bruce J. Roth )
Study ID Numbers: CDR0000543847, VU-VICC-URO-0426
Study First Received: May 8, 2007
Last Updated: October 22, 2008
ClinicalTrials.gov Identifier: NCT00471718  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009