- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00016107
Combination Chemotherapy Plus Bevacizumab in Treating Patients With Metastatic Prostate Cancer
A Phase II Study Of Estramustine, Docetaxel, And Bevacizumab (IND # 7921, NSC # 704865) In Men With Hormone Refractory Prostate Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To determine time to objective progression, response rate (objective and PSA response) and duration of response in men with hormone refractory prostate cancer treated with estramustine, docetaxel and bevacizumab.
II. To determine the toxicity of this regimen in men with hormone refractory prostate cancer.
III. To study the relationship of baseline VEGF levels in urine and plasma and changes in these levels to response and duration of response to treatment with bevacizumab, docetaxel and estramustine.
OUTLINE:
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60606
- Cancer and Leukemia Group B
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must have histologically documented adenocarcinoma of the prostate with progressive systemic (metastatic) disease despite castrate levels of testosterone due to orchiectomy or LHRH agonist (which must be continued); castrate levels of testosterone must be maintained
At the time of enrollment, patients must have evidence of metastatic disease, either:
- Measurable disease (with any PSA) OR
- Non-measurable disease with PSA >= 5 ng/ml; patients with PSA >= 5 ng/ml only are not eligible DEFINITION OF MEASURABLE DISEASE/TARGET LESIONS
- Any lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques: 1) physical exam for clinically palpable lymph nodes and superficial skin lesions, 2) chest X-ray for clearly defined lung lesions surrounded by aerated lung OR those lesions measured as >= 10 mm with a spiral CT scan or MRI
Measurable lesions (up to a maximum of 10 in number) representative of all organs involved to be identified as target lesions; the sum of the longest diameters (LD) for all target lesions will be calculated and reported as baseline sum LD
- If measurable disease is confined to a solitary lesion then its neoplastic nature will need to be confirmed by histology
- Ultrasound may not be used to measure tumor lesions that are not easily accessible clinically DEFINITION OF NON-MEASURABLE DISEASE/NON-TARGET LESIONS
Non-target lesions include all other lesions, including small lesions with longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan and truly non-measurable lesions, which include:
- Bone lesions
- Pleural or pericardial effusions, ascites
- CNS lesions, leptomeningeal disease
- Irradiated lesions, unless progression documented after RT
Patients must have demonstrated evidence of progressive disease since the most recent change in therapy; progressive disease is defined as any one of the following (measurable disease, bone scan, or PSA progression):
- MEASURABLE DISEASE PROGRESSION: Objective evidence of increase > 20% in the sum of the longest diameters (LD) of target lesions from the time of maximal regression or the appearance of one or more new lesions
- BONE SCAN PROGRESSION: Appearance of one or more new lesions on bone scan attributable to prostate cancer along with a PSA >= 5 ng/ml will constitute progression
- PSA PROGRESSION: An elevated PSA (at least >= 5 ng/ml) which has risen serially from baseline on two occasions each at least one week apart. If the confirmatory PSA (#3) value is less (i.e., #3b) than screening PSA (#2) value, then an additional test for rising PSA (#4) will be required to document progression
- Failure despite standard androgen deprivation therapy
- Flutamide and megestrol acetate (any dose) must be discontinued at least 4 weeks prior to registration; bicalutamide and nilutamide must be discontinued at least 6 weeks prior to registration. If improvement following antiandrogen withdrawal is noted, progression must be established using the criteria above; primary testicular androgen suppression (e.g., with an LHRH analogue) should not be discontinued
- At least 4 weeks since any hormonal therapy, including ketoconazole, aminoglutethimide, systemic steroids (any dose), megestrol acetate (any dose)
- No prior cytotoxic chemotherapy, including estramustine or suramin
- No prior anti-angiogenesis agents, including thalidomide and bevacizumab
- >= 4 weeks since major surgery and fully recovered
- >= 4 weeks since any prior radiation and fully recovered
- >= 8 weeks since the last dose of strontium-89 or Samarium
- Patients receiving bisphosphonate therapy prior to initiating protocol treatment must have received bisphosphonates for at least 1 month and have progressive disease despite this therapy
- CTC (ECOG) performance status: 0-2
- No myocardial infarction or significant change in anginal pattern within one year or current congestive heart failure (NYHA Class 2 or higher)
- No deep venous thrombosis or pulmonary embolus within one year. No need for full-dose oral or parenteral anticoagulation; daily prophylactic aspirin is allowed
- No clinically significant peripheral neuropathy
- Granulocytes >= 1500/ul
- Platelet count >= 100,000/ul
- Creatinine =< 1.5 x upper limit of normal
- Bilirubin =< 1.0 x upper limit of normal
- AST =< 1.5 x upper limits of normal
- Urinalysis =< 1 + protein on dipstick
- PSA >= 5 ng/ml (if non-measurable disease)
- Serum Testosterone =< 50 ng/ml for patients who have not had bilateral orchiectomy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (chemotherapy, bevacizumab)
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.
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Correlative studies
Given IV
Other Names:
Given IV
Other Names:
Given orally
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to objective progression
Time Frame: From the initiation of treatment to the date of progressive disease, assessed up to 2 years
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The Kaplan-Meier method will be used to estimate the time to disease progression.
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From the initiation of treatment to the date of progressive disease, assessed up to 2 years
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Response rates (PSA and objective)
Time Frame: Up to 2 years
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Response rates will be analyzed using both objective (CR and PR) and serological parameters.
The Kaplan-Meier method will be used to estimate the response (objective and PSA) duration.
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Up to 2 years
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Toxicity as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 2.0
Time Frame: Up to 2 years
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Up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: Up to 2 years
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The Kaplan-Meier method will be used to estimate the overall survival.
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Up to 2 years
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Duration of response
Time Frame: From the date of the first CR or PR to the date that the patient had progressive disease, assessed up to 2 years
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Duration of PSA response is the date from the first 50% decline (or 75% decline) in PSA to the date when the patient met the criteria for progressive disease.
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From the date of the first CR or PR to the date that the patient had progressive disease, assessed up to 2 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joel Picus, Cancer and Leukemia Group B
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Docetaxel
- Antibodies
- Immunoglobulins
- Bevacizumab
- Antibodies, Monoclonal
- Antineoplastic Agents, Immunological
- Estramustine
Other Study ID Numbers
- NCI-2012-02962
- U10CA031946 (U.S. NIH Grant/Contract)
- CALGB-90006
- CDR0000068595
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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