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Combination Chemotherapy Plus Bevacizumab in Treating Patients With Metastatic Prostate Cancer
This study has been completed.

First Received on May 6, 2001.   Last Updated on March 30, 2011   History of Changes
Sponsor: Cancer and Leukemia Group B
Collaborator: National Cancer Institute (NCI)
Information provided by: Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT00016107
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab may stop the growth of cancer cells by stopping blood flow to the tumor. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus monoclonal antibody therapy in treating patients who have metastatic prostate cancer that has not responded to previous hormone therapy.


Condition Intervention Phase
Prostate Cancer
Biological: bevacizumab
Drug: docetaxel
Drug: estramustine phosphate sodium
Phase II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Estramustine, Docetaxel, And Bevacizumab (IND # 7921, NSC # 704865) In Men With Hormone Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Cancer and Leukemia Group B:

Primary Outcome Measures:
  • Time to progression [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response [ Time Frame: q tx cycle then q 3 mon for 24 mon ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: q tx cycle ] [ Designated as safety issue: Yes ]
  • PSA Levels [ Time Frame: q Tx cycle, then q 3 mon for 24 mon ] [ Designated as safety issue: No ]

Enrollment: 79
Study Start Date: June 2001
Study Completion Date: April 2009
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemotherapy + Antibody Therapy
Addition of antibody Bevacizumab to chemotherapy treatment
Biological: bevacizumab
15mg/kg IV infusion on Day 2 of each cycle
Drug: docetaxel
70mg/sq m IV infusion over 1 hour on Day 2 of each cycle
Drug: estramustine phosphate sodium
280 mg PO tid days 1- of each cycle

Detailed Description:

OBJECTIVES:

  • Determine the time to objective progression, response rate, and duration of response in patients with hormone-refractory metastatic prostate cancer treated with bevacizumab, estramustine, and docetaxel.
  • Determine the toxicity of this regimen in these patients.
  • Assess the relationship of baseline vascular endothelial growth factor levels in urine and plasma and changes in these levels with response and duration of response in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to urine vascular endothelial growth factor level (low vs high).

Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour followed by bevacizumab IV over 30-90 minutes on day 2. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at least every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 72 patients (36 per stratum) will be accrued for this study within 18 months.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • Metastatic disease despite castrate levels of testosterone due to orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist

    • Refractory to standard androgen deprivation therapy
  • Measurable disease with any PSA level

    • Target lesion at least 20 mm by physical exam or chest x-ray OR
    • At least 10 mm by spiral CT scan
    • Histological confirmation of neoplastic nature required if disease is confined to only 1 target lesion OR
  • Non-measurable disease with PSA at least 5 ng/mL

    • Bone lesions
    • Pleural or pericardial effusions or ascites
    • CNS lesions or leptomeningeal disease
    • Previously irradiated lesions, unless progression documented after radiotherapy
  • Progressive disease

    • Objective evidence of greater than 20% increase in the sum of the longest diameters of target lesions for measurable disease
    • Progression by bone scan or PSA for non-measurable disease
  • Castrate levels of testosterone must be maintained
  • Serum testosterone no greater than 50 ng/mL for patients without prior bilateral orchiectomy

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • CTC (ECOG) 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than upper limit of normal (ULN)
  • AST no greater than 1.5 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN
  • Urinalysis no greater than 1+ protein on dipstick

Cardiovascular:

  • No myocardial infarction or significant change in anginal pattern within the past year
  • No congestive heart failure (New York Heart Association class II-IV heart disease)
  • No deep vein thrombosis within the past year

Pulmonary:

  • No pulmonary embolus within the past year

Other:

  • No clinically significant peripheral neuropathy
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior antiangiogenesis agents, including thalidomide and bevacizumab

Chemotherapy:

  • No prior cytotoxic chemotherapy, including estramustine and suramin
  • No other concurrent chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • At least 4 weeks since any hormonal therapy, including ketoconazole, aminoglutethimide, corticosteroids, flutamide, or megestrol
  • At least 6 weeks since prior bicalutimide and nilutimide
  • No concurrent hormonal therapy except steroids for adrenal insufficiency or nondisease-related conditions (e.g., insulin for diabetes)
  • Concurrent testicular androgen suppression (e.g., LHRH analog) allowed, if initiated before study

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • At least 8 weeks since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • At least 4 weeks since prior major surgery and recovered

Other:

  • No requirement for full-dose or parenteral anticoagulation
  • Daily prophylactic aspirin allowed
  • No concurrent bisphosphonate therapy unless initiated at least 1 month prior to study with progressive disease despite this therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00016107

  Show 55 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Joel Picus, MD Washington University Siteman Cancer Center
  More Information

Additional Information:
Publications:
Picus J, Halabi S, Rini B, et al.: The use of bevacizumab (B) with docetaxel (D) and estramustine (E) in hormone refractory prostate cancer (HRPC): initial results of CALGB 90006. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1578, 2003.

Responsible Party: Monica M Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT00016107     History of Changes
Other Study ID Numbers: CDR0000068595, U10CA031946, CLB-90006
Study First Received: May 6, 2001
Last Updated: March 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Cancer and Leukemia Group B:
adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Estramustine
Docetaxel
Bevacizumab
Sodium phosphate
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Cathartics
Gastrointestinal Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012