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

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Genentech, Inc.; Lowell General Hospital; Massachusetts General Hospital; Saint Anne's Hospital
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

• 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

• Proteinuria at screening as demonstrated by either Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening OR Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).

• Known hypersensitivity to any component of avastin

• Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to give informed consent or cooperate and participate in the study or to interfere with the investigator's ability to interpret the results