Ovarian Cancer Clinical Trial
Official title:
A Phase II Evaluation of Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma
Verified date | June 2014 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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 mullerian carcinoma. We will also collect more information about the safety and side effects of this combination of drugs. Gemcitabine and oxaliplatin are chemotherapy drugs that kill cancer cells. Bevacizumab is a new anti-cancer drug that works to slow or stop cell growth in cancerous tumors by decreasing the blood supply to the tumors.
Status | Terminated |
Enrollment | 19 |
Est. completion date | October 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Brigham and Women's Hospital, Eli Lilly and Company, Genentech, Inc., Massachusetts General Hospital, Sanofi-Synthelabo |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Partial Response Rate | Precentage of women who responded to the treatment regimen Response was determined by RECIST criteria | Outcome was assessed every 2 cycles (every 8 weeks) for the duration on study, an average of 4.5 cycles (18 weeks) | No |
Secondary | Progression Free Survival | Time participant remains free of progression of her disease. Evaluated by RECIST criteria | Assessed every 2 cycles (every 8 weeks) of chemotherapy until progression of disease is documented with a median duration of follow up of 24 months | No |
Secondary | Overall Survival | Duration of time participants are alive after enrolling on the study. Assessed by clinical records | Assessed every 3 months until death from disease, other causes, or loss to follow up at a median follow up of 24 months | No |
Secondary | Determine the Nature and Degree of Toxicities Following Treatment With Oxaliplatin, Gemcitabine, and Bevacizumab in This Patient Population. | The nature and toxicities of treatment were graded per the National Cancer Institute Common Terminology Criteria of Adverse Events version 3.0 Patients with grade 2 or higher toxicity were reported | Toxicities were assessed every cycle and for up to 30 days after being removed from the trial | Yes |
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