Status:
TERMINATED
Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Massachusetts General Hospital
Brigham and Women's Hospital
Conditions:
Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The main purpose of this study is to begin to collect information and try to learn whether or not the combination of oxaliplatin, gemcitabine and bevacizumab works in treating women with recurrent mul...
Detailed Description
* The study treatment is divided into periods called cycles. Each cycle is 28 days long. Participants will be given the study drugs intravenously on day 1 and day 15 of each cycle. * Gemcitabine will ...
Eligibility Criteria
Inclusion
- Recurrent ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic or cytologic confirmation of the original primary tumor is required.
- Must have measurable disease which is defined as at least one lesion that can be accurately measured in at least one dimension. Each lesion must be \>20mm when measured by 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
- Chemotherapy within last 3 weeks
- Current, recent (within 4 weeks), or planned participation in an experimental drug study 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 days prior to study entry or the anticipation of need for major surgical procedure during the course of the study.
- Minor surgical procedures within 14 days of study entry.
- Significant cardiovascular disease, New York Heart Association Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, a history of deep vein thrombosis, or Grade II or greater, clinically significant peripheral vascular 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 skin cancer, 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00418093
Start Date
September 1 2006
End Date
October 1 2011
Last Update
June 19 2014
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215