Docetaxel, Prednisone, and Vatalanib in Treating Patients With Advanced Prostate Cancer

NCT ID: NCT00293371

Last Updated: 2012-10-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2006-09-30

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vatalanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving vatalanib together with docetaxel and prednisone may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of vatalanib when given together with docetaxel and prednisone and to see how well they work in treating patients with advanced prostate cancer.

Detailed Description

OBJECTIVES:

Primary

• Determine the dose-limiting toxicities and maximum tolerated dose of vatalanib when used in combination with docetaxel and prednisone in patients with chemotherapy-naive, metastatic, hormone-refractory prostate cancer. (phase I)

Secondary

• Determine alterations in pharmacokinetics of docetaxel and vatalanib in these patients. (phase I)
• Determine the clinical efficacy of this regimen as measured by declines in prostate-specific antigen, measurable disease response, time to progression, and overall survival. (phase II)

OUTLINE: This is a phase I open-label, dose-escalation study of vatalanib* followed by a phase II study.

• Phase I: Patients receive docetaxel IV over 1 hour on day 2. Patients also receive oral prednisone twice daily and oral vatalanib once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
• Cohorts of 3-6 patients receive escalating doses of vatalanib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

NOTE: *Vatalanib is administered on days 5-21 during the first course only.

• Phase II: Patients receive prednisone, docetaxel, and vatalanib at the MTD as in phase I. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 93 patients will be accrued for this study.

Conditions

Prostate Cancer

Keywords

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

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

docetaxel

Intervention Type: DRUG

prednisone

Intervention Type: DRUG

vatalanib

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• No psychiatric illness or social situation that would limit compliance with treatment
• No "currently active" second malignancy other than nonmelanoma skin cancers

• Not considered "currently active" if competed therapy and at < 30% risk of relapse
• No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No grapefruit or grapefruit juice during study treatment
• No history of gastrectomy/small bowel resection
• At least 4 weeks since prior hormonal therapy, including ketoconazole, aminoglutethimide, systemic steroids (any dose), and megestrol acetate (any dose)
• At least 4 weeks since prior drug or herbal product known to decrease PSA levels (e.g., finasteride, saw palmetto, or PC-SPES)
• At least 4 weeks since prior major surgery and fully recovered
• At least 4 weeks since prior radiation therapy and fully recovered
• At least 8 weeks since the last dose of prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium
• Patients receiving bisphosphonate therapy prior to initiating protocol treatment must have received bisphosphonates for at least the past month

• No bisphosphonate initiation for 1 month prior to and during study treatment
• No prior systemic chemotherapy for prostate cancer
• No prior antiangiogenic agents (thalidomide, bevacizumab)
• No other concurrent chemotherapy, investigational agents, radiotherapy (including palliative), or biologic therapy
• No biologic therapy or immunotherapy ≤ 4 weeks prior to study treatment
• No more than 1 prior therapy with an investigational agent, completed ≥ 4 weeks prior to study treatment
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No concurrent therapeutic warfarin or similar oral anticoagulant that is metabolized by the cytochrome p450 system

• Heparin is allowed
• No other concurrent hormonal therapy except for the following:

• Steroids for adrenal failure
• Hormones for nondisease-related conditions (e.g., insulin for diabetes)
• Intermittent dexamethasone

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric J. Small, MD

Role: STUDY_CHAIR

University of California, San Francisco

Locations

UCSF Comprehensive Cancer Center

San Francisco, California, United States

Countries

United States

Other Identifiers

UCSF-04557

Identifier Type: -

Identifier Source: secondary_id

CDR0000456195

Identifier Type: -

Identifier Source: org_study_id