Safety Study Of Avastin And Pelvic Radiation In Women With Recurrent Gynecological Cancers

NCT00545792 | Completed Phase 2 Results DMC

• 2 other identifiers: 07-042AVF3998s
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is evaluating a drug called avastin in combination with standard radiation as a possible treatment for treatment for recurrent pelvic-confined gynecological cancer (i.e. endometrial, cervical, vulvar, ovarian or vaginal cancers).

Conditions

Cervical Cancer; Endometrial Cancer; Ovarian Cancer; Vaginal Cancer; Carcinoma of the Vulva

Keywords

Recurrent Endometrial cancer; Recurrent Cervical cancer; Recurrent Ovarian cancer; Recurrent Vaginal cancer; Recurrent Vulvar cancer; Vaginal recurrence; Brachytherapy; Radiation Treatment; External Beam Radiation; Avastin; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• Toxicity Rates of Patients Treated With Concurrent Avastin and Daily Pelvic Radiation With no Other Concurrent Chemotherapy

  Toxicity was the cumulative number of events, all grades and categories, related to side effects from avastin and radiation including, but not limited to, bowel, bladder, skin, gynecologic and other morbidity.

  1-year

Secondary Outcomes (1)

• Single Point Estimate of 1-year Progression-free Survival of Patients Treated With Concurrent Avastin and Daily Pelvic Radiation With no Other Concurrent Chemotherapy

  1-year

Study Arms (1)

Avastin

EXPERIMENTAL

Avastin

Drug: Avastin

Interventions

Avastin DRUG

Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses.

Also known as: Bevacizumab

Avastin

Eligibility Criteria

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

You may qualify if:

• All patients (age \> 18 years) will have locally recurrent gynecological cancer with a component of disease that will fit within a standard RT portal at the time of presentation
• ECOG performance status score 0-1
• All patients will have had a prior hysterectomy
• Histological confirmation of recurrent gynecological cancer, including adenocarcinoma, papillary serous carcinoma, clear cell carcinoma, or carcinosarcoma
• Age \> 18 years
• Radiologic work-up computer tomography of the chest and abdomen, and computer tomography or MR of the pelvis confirming pelvis-confined recurrence
• Adequate renal function as evidenced by serum creatinine \< 1.5 mg/dL
• Adequate hepatic function as evidenced by:
• Serum total bilirubin \< 1.5 mg/dL SGOT/SGPT \< 3X the ULN for the reference lab
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Patients with a prior history of full course external beam radiation therapy to the pelvis (patients with prior vaginal brachytherapy may be included)
• Inability to comply with study and/or follow-up procedures
• Life expectancy of less than 12 weeks
• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored avastin cancer study
• Known CNS disease (including history of encephalitis, multiple sclerosis or seizure disorder), except for treated brain metastasis
• 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
• History of myocardial infarction or unstable angina within 6 months prior to study enrollment
• History of stroke or transient ischemic attack within 6 months prior to study enrollment
• Known CNS disease (including history of encephalitis, multiple sclerosis or seizure disorder)
• Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
• Symptomatic peripheral vascular disease
• Evidence of bleeding diathesis or coagulopathy
• Any surgical procedure requiring an incision, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for any surgical procedure requiring an incision during the course of the study (excluding vascular access device placement or procedures that do not require an incision)

Sponsors & Collaborators

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

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Viswanathan AN, Lee H, Berkowitz R, Berlin S, Campos S, Feltmate C, Horowitz N, Muto M, Sadow CA, Matulonis U. A prospective feasibility study of radiation and concurrent bevacizumab for recurrent endometrial cancer. Gynecol Oncol. 2014 Jan;132(1):55-60. doi: 10.1016/j.ygyno.2013.10.031. Epub 2013 Nov 4.

  PMID: 24201015 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Ovarian Neoplasms; Vaginal Neoplasms; Vulvar Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Vaginal Diseases; Vulvar Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Akila N. Viswanathan, MD, MPH
• Organization: Dana-Farber Cancer Institute

aviswanathan@lroc.harvard.edu

617-732-6331

Study Officials

• Paul Nguyen, 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: Paul Nguyen MD

Study Record Dates

• First Submitted: October 15, 2007
• First Posted: October 17, 2007
• Study Start: May 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: October 1, 2013
• Last Updated: March 15, 2017
• Results First Posted: July 2, 2014

Record last verified: 2017-02

Locations

US (1)