Phase
Condition
Carcinoma
Pelvic Cancer
Fallopian Tube Cancer
Treatment
N/AClinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Recurrent ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic orcytologic confirmation of the original primary tumor is required.
Must have measurable disease which is defined as at least one lesion that can beaccurately measured in at least one dimension. Each lesion must be >20mm when measuredby conventional techniques.
Must have at least one "target lesion" to be used to assess response.
Platinum-sensitive tumors, defined as a platinum free interval of at least 6 months,and may have had up to two prior treatment regimens.
Eastern Cooperative Oncology Group score of 0 or 1
Life expectancy of 12 weeks or longer
18 years of age or older
Adequate bone marrow, renal, neurologic and liver function
Normal blood coagulation parameters
Exclusion
Exclusion Criteria:
Chemotherapy within last 3 weeks
Current, recent (within 4 weeks), or planned participation in an experimental drugstudy other than a Genentech-sponsored bevacizumab cancer study.
Known bleeding disorder or coagulopathy, or history of stroke.
Major surgical procedure, open biopsy, or significant traumatic injury within 28 daysprior to study entry or the anticipation of need for major surgical procedure duringthe course of the study.
Minor surgical procedures within 14 days of study entry.
Significant cardiovascular disease, New York Heart Association Grade II or greatercongestive heart failure, serious cardiac arrhythmia requiring medication, a historyof deep vein thrombosis, or Grade II or greater, clinically significant peripheralvascular disease within 1 year of study entry.
Urine protein:creatinine ration greater than or equal to 1.0
History or clinical evidence of central nervous system disease
Patients with other invasive malignancies, with the exception of non-melanoma skincancer, who have evidence of disease within last three years.
More than 2 prior lines of chemotherapy
Previous treatment with a VEGF targeted inhibitor or antibody
Serious non-healing wound, ulcer or bone fracture
Prior radiation therapy to more than one-third of hematopoietic sites.
History of abdominal fistulas, gastrointestinal perforation, intra-abdominal abscess,or partial bowel obstruction within 6 months
Pregnant or lactating
Study Design
Study Description
Connect with a study center
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
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