Docetaxel, Bevacizumab and Androgen Deprivation Therapy After Definitive Local Therapy for Prostate Cancer

NCT00658697 | Completed Phase 2 Results DMC

• 1 other identifier: 08-004
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 3

Brief Summary

In this research study, we aim to evaluate the feasibility, toxicity and efficacy of early multimodality systemic therapy (a combination of docetaxe, bevacizumab, and androgen deprivation therapy(ADT) in men with biochemical recurrence (BCR) or who have a rising Prostate Specific Antigen (PSA) after treatment of their prostate cancer with surgery or radiation)

Conditions

Prostate Cancer

Keywords

Rising PSA; androgen deprivation; bevacizumab (avastin); docetaxel; lupron; zoladex; bicalutamide

Outcome Measures

Primary Outcomes (1)

• Prostate-Specific Antigen (PSA) Progression at 1 Year After Completing Androgen Deprivation Therapy (ADT)

  For prostatectomy patients: at least two serial rising PSA from treatment nadir and PSA \> 0.2 ng/mL. For patient receiving radiation therapy alone as primary local therapy, at least two serial rising PSA from treatment nadir and PSA \>2.0 ng/mL. Any new site of metastatic disease on imagining would be considered progression regardless of PSA value Clinical assessments (Vitals, Physical Exam, Performance Status, PSA and testosterone) were performed every 3 months starting at completion of hormone therapy until PSA progression.

  participants were followed for the duration of the study, an average of 2 years

Secondary Outcomes (4)

• Proportion of Patients With PSA Responses at One Year After the Completion of ADT

  1 year + 3 month off last ADT injection

• Time to PSA Progression (TTP)

  participants were followed for the duration of the study, an average of 2 years

• Testosterone Recovery

  2 years

• Toxicity

  Assessed each cycle throughout treatment form time of first dose to 30 days post-treatment, up to 2 years

Study Arms (1)

Docetaxel, Bevacizumab, and ADT

EXPERIMENTAL

Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles ADT or Luteinizing hormone-releasing hormone agonist (LHRH): Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) Bicalutamide: Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)

Drug: Docetaxel; Drug: Bevacizumab; Drug: ADT; Drug: Bicalutamide

Interventions

Docetaxel DRUG

Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles

Also known as: Taxotere, Docecad

Docetaxel, Bevacizumab, and ADT

Bevacizumab DRUG

Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles

Also known as: Avastin

Docetaxel, Bevacizumab, and ADT

ADT DRUG

Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)

Also known as: Lupron or Zoladex

Docetaxel, Bevacizumab, and ADT

Bicalutamide DRUG

Starting on day 84 orally once daily until hormone therapy is completed

Also known as: Casodex, Cosudex, Calutide, Kalumid

Docetaxel, Bevacizumab, and ADT

Eligibility Criteria

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

You may qualify if:

• years of age or older
• History of biopsy documented prostate cancer (any Gleason score)
• Past treatment with prostatectomy with our without salvage prostate/pelvic radiation or primary radiation
• If past prostatectomy, pathologic stage no greater than T1-3, N1, M0
• PSA recurrence with PSAdt 8 months or less. There is no minimum PSA for prostatectomy patients. For patients treated with primary radiation therapy PSA should be 2.0ng/ml or greater
• No evidence of recurrent disease on exam, bone scan, CT/MRI abdomen/pelvis on CXR
• Prior ADT allowed if less than 6 months and testosterone recovered to within 50 units of normal range
• ECOG Performance status of 0-1
• Absolute neutrophil count of 1,500 mm3 or greater
• Platelet Count 100,000 mm3 or greater
• Total bilirubin within normal limits
• HG 8gm/dl or greater
• Testosterone within 50 units of normal range
• No history of bleeding or thromboses within the last 12 months that required medical intervention

You may not qualify if:

• History of cancer within 5 years, other than prostate cancer and non-melanoma skin cancer
• Medical condition requiring concomitant corticosteroids
• Active infection
• Prior chemotherapy
• Neuropathy requiring medical therapy
• Documented local recurrence or metastatic prostate cancer
• Inability to comply with study and/or follow-up procedures
• Life expectancy of less than 2 years
• Current, recent (within 4 weeks of first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin cancer study
• Inadequately controlled hypertension
• Any prior history of hypertensive crisis or hypertensive encephalopathy
• NYHA Grade II or greater congestive heart failure
• History of myocardial infarction or unstable angina within 12 months prior to study enrollment
• History of stroke or transient ischemic attack at any time
• Known CNS disease

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Genentech, Inc.: collaborator

Study Sites (3)

University of Maryland - Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Bevacizumab; Leuprolide; Goserelin; bicalutamide

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)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Oligopeptides; Nerve Tissue Proteins

Results Point of Contact

• Title: Rana R. McKay, MD
• Organization: DFCI

rana_yehia@dfci.harvard.edu

6176323237

Study Officials

• Mary-Ellen Taplin, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, HMS

Study Record Dates

• First Submitted: April 9, 2008
• First Posted: April 15, 2008
• Study Start: June 1, 2008
• Primary Completion: September 1, 2014
• Study Completion: June 1, 2015
• Last Updated: May 25, 2017
• Results First Posted: August 26, 2015

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)