Bevacizumab in Treating Patients With Relapsed Prostate Cancer That Did Not Respond to Hormone Therapy

NCT01656304 | Completed Phase 2 Results DMC

• 2 other identifiers: 2006-064NCI-2011-00661
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

This pilot phase II trial studies how well giving bevacizumab works in treating patients with relapsed prostate cancer that did not respond to hormone therapy. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or tumor-killing substances to them. Bevacizumab may also stop the growth of prostate cancer by blocking blood flow to the tumor

Conditions

Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• PSA Response Rate With Bevacizumab Therapy in Androgen Independent Non-metastatic Prostate Cancer

  A PSA response will be considered a PSA decline of at least 50% must be confirmed by a second PSA value four or more weeks later. The reference PSA for these declines should be a PSA measured within 2 weeks prior to the initiation of therapy. Response rates will be summarized by point estimates and Wilson type 80% confidence intervals.

  An average every 6 weeks for up to 3 months

• Toxicities Associated With Bevacizumab Therapy

  Toxicity rates will be summarized by point estimates and Wilson type 90% confidence intervals. Toxicities will be graded per the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), and PSA response will be determined as per PSA Working Group response criteria. Censored time to PSA progression will be estimated with standard Kaplan-Meier methodology.

  An average of every 2 weeks while on therapy

• Time to PSA Progression (TTPP)

  TTPP will be measured from protocol registration to appearance of PSA progression as defined by the criteria of the PSA Working Group response criteria. The end point for progression will be calculated at the time a 25% increase in PSA has been achieved. PSA velocity will also be calculated as change in PSA doubling time pre and post therapy and the rate of PSA rise pre- and post-therapy.

  An average every 6 weeks for up to 3 months

Secondary Outcomes (3)

• Overall Survival of Androgen Independent Non-metastatic Prostate Cancer Patients Treated With Bevacizumab

  Every 3 months

• The Change in PSA Velocity With Bevacizumab Therapy in Androgen Independent Non-metastatic Prostate Cancer

  Baseline, every 6 weeks while on therapy, and then every 3 months thereafter

• Time to Distant Metastatic Disease

  Every 3 months

Study Arms (1)

Treatment (monoclonal antibody, antiangiogenesis)

EXPERIMENTAL

Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.

Biological: bevacizumab; Other: laboratory biomarker analysis

Interventions

bevacizumab BIOLOGICAL

Given IV

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

Treatment (monoclonal antibody, antiangiogenesis)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (monoclonal antibody, antiangiogenesis)

Eligibility Criteria

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

You may qualify if:

• A histologic diagnosis of prostate adenocarcinoma.
• No evidence of bone/visceral metastases as visualized on standard imaging such as bone scan, chest X-ray, CT scan or MRI of abdomen and pelvis.
• PSA-only progression despite androgen deprivation therapy. PSA progression is defined as 3 rising levels, with a minimum interval of 2 weeks between each determination. The last determination must have a minimum value of
• ng/ml and be determined within two weeks prior to registration. If the second or third confirmatory value is less than the previous value, the patient will still be eligible if a repeat value (No. 4) is found to be greater than all the prior values.
• If patient has been on antiandrogen in the past 28 days, then PSA progression after withdrawal period (28 days for flutamide and 42 days for bicalutamide or nilutamide) is required.
• ECOG performance status of 0-1.
• No prior avastin therapy.
• No investigational or commercial agents or therapies (except LHRH agonists) may be administered concurrently with the intent to treat the patient's malignancy. Patients on LHRH agonists must continue the use of LHRH agonist therapy. Bisphosphonates can be administered per treating physician discretion.
• At least 4 weeks must have elapsed since prior systemic therapy, except for LHRH analogue therapy and steroids. If steroids are being used for therapy of prostate cancer, these should be discontinued prior to starting avastin therapy.
• Age ≥ 18 years.
• Life expectancy of at least 6 months.
• Ability to understand and the willingness to sign a written informed consent that is approved by the Institutional Human Investigation Committee.
• Use of effective means of contraception in subjects.

You may not qualify if:

• Inability to comply with study and/or follow-up procedures.
• Inadequately controlled hypertension (defined as systolic blood pressure \>150 and/or diastolic blood pressure \> 100 mmHg on antihypertensive medications).
• Any prior history of hypertensive crisis or hypertensive encephalopathy.
• New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix E).
• History of myocardial infarction or unstable angina within last 12 months prior to study enrollment.
• History of stroke or transient ischemic attack within 6 months prior to study enrollment.
• Known CNS disease.
• Significant vascular disease (e.g., aortic aneurysm, aortic dissection).
• Symptomatic peripheral vascular disease.
• Evidence of bleeding diathesis or coagulopathy.
• Patients on anticoagulants are allowed if patient has been on therapy for at least 4 weeks and patient has no acute thromboembolic activity.
• Major surgical procedure, open biopsy, or significant traumatic injury within. 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study.
• Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment.
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment.
• Serious, non-healing wound, ulcer, or bone fracture.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• Genentech, Inc.: collaborator

Study Sites (2)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

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)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

There was a small sample size.

Results Point of Contact

• Title: Ulka Vaishampayan, M.D.
• Organization: Barbara Ann Karmanos Cancer Institute

vaishamu@karmanos.org

(313) 576-8718

Study Officials

• Ulka Vaishampayan

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2012
• First Posted: August 2, 2012
• Study Start: May 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 31, 2018
• Results First Posted: July 8, 2014

Record last verified: 2018-07

Locations

US (2)