Sorafenib and Docetaxel in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00589420
First received: December 25, 2007
Last updated: July 7, 2009
Last verified: July 2009
  Purpose

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

PURPOSE: This phase II trial is studying giving sorafenib together with docetaxel to see how well it works in treating patients with metastatic androgen-independent prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: docetaxel
Drug: sorafenib tosylate
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Sorafenib in Combination With Docetaxel in Patients With Androgen-Independent Prostate Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • PSA response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 6-month progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Objective response rate [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 69
Study Start Date: October 2006
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine the proportion of patients achieving a 50% reduction in serum PSA from baseline in patients with androgen-independent prostate cancer (AIPC) receiving sorafenib tosylate and docetaxel.

Secondary

  • To estimate the progression-free survival of patients with AIPC.
  • To quantify the number and percent of patients who have stable disease at 6 months of therapy (failure to progress).
  • To estimate median time to progression for all patients.
  • To estimate the objective response rate of patients with AIPC treated with this regimen.
  • To measure the percentage of patients surviving at 2 years.
  • To determine the toxicities and estimate toxicity rates for patients treated with this regimen.
  • To measure changes in tumor vasculature in response to therapy in selected patients with dynamic contrast-enhanced MRI (DCE-MRI) and correlate primary and secondary objectives to these measurement changes.
  • To measure changes in serum HMGB1 in response to therapy and correlate primary and secondary objectives with these changes.
  • To measure changes in serum cathepsin D in response to therapy and correlate primary and secondary objectives with these changes.

OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 2-19 and docetaxel IV on day 1. Treatment repeats every 21 days for up to 10 courses. Patients then receive oral sorafenib tosylate alone twice daily on days 1-19 with treatment repeating every 21 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection periodically to measure serum HMGB1 and cathepsin D levels before and after therapy.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate

    • Androgen-independent disease
    • Metastatic disease measured by clinical or radiological evidence
  • Disease progression during hormonal therapy, defined by one or more of the following:

    • Increasing serum PSA levels on ≥ 2 measurements at least two weeks apart
    • Progressive measurable disease (by RECIST criteria) independent of PSA
    • Bone scan progression with at least one new lesion
  • Must be receiving primary androgen ablation therapy with gonadotropin-releasing hormone agonists (GnRH) as maintenance therapy unless surgically castrated
  • Serum PSA > 5 ng/mL
  • No history of brain metastasis or leptomeningeal disease

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • WBC ≥ 3,000/mm³
  • Absolute granulocyte count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 2.0 times the upper limit of normal (ULN)
  • Total bilirubin normal
  • AST and ALT ≤ 5 times ULN
  • INR ≤ 1.5 and PTT normal (before the start of chronic anticoagulation)
  • Fertile patients must use effective contraception during and for ≥ 3 months after completion of study therapy
  • No symptomatic neuropathy grade ≥ 2
  • No HIV positivity
  • No history of cancer except basal cell or squamous-cell skin cancer within the past 5 years
  • No history of deep vein thrombosis or pulmonary embolism within the past year
  • No serious medical illness including, but not limited to, any of the following:

    • Ongoing or active infection requiring parental antibiotics
    • Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, recent myocardial infarction, unstable angina)
    • NYHA class II-IV congestive heart failure
    • NYHA class II-IV peripheral arterial vascular disease within the past year
    • Psychiatric illness or social situations that would limit study compliance
  • No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 4 weeks since prior flutamide or nilutamide (6 weeks for bicalutamide)
  • At least 4 weeks since prior radiotherapy

    • Must have radiographic evidence of progression of any lesion that has received radiotherapy in order for that lesion to constitute measurable disease or be considered a measured target lesion
  • Prior vaccine therapy allowed
  • Prior and/or concurrent zoledronic acid therapy allowed
  • No prior cytotoxic chemotherapy
  • No prior radioisotope therapy
  • No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital)
  • No concurrent rifampin or St. John's wort
  • No concurrent inhibitors of CYP3A, including any of the following:

    • Ketoconazole
    • Voriconazole
    • Itraconazole
    • Fluconazole
    • Cimetidine
    • Clarithromycin
    • Erythromycin
    • Troleandomycin
    • Grapefruit juice
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • Concurrent bisphosphonate therapy allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589420

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-4283
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers    800-474-9892      
Sponsors and Collaborators
University of Pennsylvania
Investigators
Investigator: Amy Kramer, RN, MPA Abramson Cancer Center of the University of Pennsylvania
  More Information

Additional Information:
No publications provided

Responsible Party: Amy Kramer, Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00589420     History of Changes
Other Study ID Numbers: CDR0000581020, UPCC-03806, SANOFI-AVENTIS-UPCC-03806
Study First Received: December 25, 2007
Last Updated: July 7, 2009
Health Authority: Unspecified

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Sorafenib
Niacinamide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014