Combination Chemotherapy Plus Bevacizumab in Treating Patients With Metastatic Prostate Cancer

NCT00016107 | Completed Phase 2

• 4 other identifiers: NCI-2012-02962CALGB-90006CDR0000068595U10CA031946
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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.

Conditions

Adenocarcinoma of the Prostate; Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• Time to objective progression

  The Kaplan-Meier method will be used to estimate the time to disease progression.

  From the initiation of treatment to the date of progressive disease, assessed up to 2 years

• Response rates (PSA and objective)

  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.

  Up to 2 years

• Toxicity as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 2.0

  Up to 2 years

Secondary Outcomes (2)

• Overall survival

  Up to 2 years

• Duration of response

  From the date of the first CR or PR to the date that the patient had progressive disease, assessed up to 2 years

Study Arms (1)

Treatment (chemotherapy, bevacizumab)

EXPERIMENTAL

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.

Drug: estramustine phosphate sodium; Drug: docetaxel; Biological: bevacizumab; Other: laboratory biomarker analysis

Interventions

estramustine phosphate sodium DRUG

Given orally

Also known as: EM, Emcyt, Estracyt, Ro 22-2296/000

Treatment (chemotherapy, bevacizumab)

docetaxel DRUG

Given IV

Also known as: RP 56976, Taxotere, TXT

Treatment (chemotherapy, bevacizumab)

bevacizumab BIOLOGICAL

Given IV

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

Treatment (chemotherapy, bevacizumab)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (chemotherapy, bevacizumab)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Estramustine; Docetaxel; Bevacizumab

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Joel Picus

  Cancer and Leukemia Group B

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2001
• First Posted: June 10, 2003
• Study Start: June 1, 2001
• Primary Completion: February 1, 2007
• Last Updated: June 5, 2013

Record last verified: 2013-06

Locations

US (1)