Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma
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.
Fallopian Tube Cancer
Primary Peritoneal Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma|
- Partial Response Rate [ Time Frame: Outcome was assessed every 2 cycles (every 8 weeks) for the duration on study, an average of 4.5 cycles (18 weeks) ] [ Designated as safety issue: No ]Precentage of women who responded to the treatment regimen Response was determined by RECIST criteria
- Progression Free Survival [ Time Frame: 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 ] [ Designated as safety issue: No ]Time participant remains free of progression of her disease. Evaluated by RECIST criteria
- Overall Survival [ Time Frame: Assessed every 3 months until death from disease, other causes, or loss to follow up at a median follow up of 24 months ] [ Designated as safety issue: No ]Duration of time participants are alive after enrolling on the study. Assessed by clinical records
- Determine the Nature and Degree of Toxicities Following Treatment With Oxaliplatin, Gemcitabine, and Bevacizumab in This Patient Population. [ Time Frame: Toxicities were assessed every cycle and for up to 30 days after being removed from the trial ] [ Designated as safety issue: Yes ]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
|Study Start Date:||September 2006|
|Study Completion Date:||October 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
All patients received oxaliplatin, gemcitabine, and bevacizumab
Given intravenously over 30 minutes on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression.Drug: Oxaliplatin
Given intravenously over 2 hours on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression.Drug: Bevacizumab
Given intravenously over 30-90 minutes on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression.
- 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 be given first, over a period of 30 minutes. Then oxaliplatin over a period of 2 hours. Finally, bevacizumab will be given over a period of 30 to 90 minutes. Participants will continue study treatment as long as their tumor is not growing and they are not experiencing unacceptable side effects. If the tumor goes away completely, the participant will have 2 more cycle of study treatment.
- Blood will be drawn for routine testing every week during study treatment to check for side effects. Before day 1 and 15 of each cycle the following tests and procedures will be performed: a medical history; complete physical exam; vital signs; blood tests; and urine tests. Before day 1 of every other cycle, the following additional procedures will be performed: A CT scan, x-ray or ultrasound of your abdomen and pelvis; an x-ray of the chest (if required by the study doctor); blood tests; and urine samples.
- If the participant's tumor goes away, they will be asked to return to the clinic for follow-up visits every 3 months for 2 years, then every 6 months for 3 years. At each follow-up visit the following tests and procedures will be performed: medical history; complete physical examination; CT scan, x-ray or ultrasound of the abdomen and pelvis; x-ray of the chest; and other tests if the doctor feels they are needed.
- There is an optional sub-study that six subjects will be asked to take a part in that will give the study doctors important information about the way the body uses and breaks down the study drugs. This sub-study will involve special surgical procedures and scans that will be done during cycle 1 of the study treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00418093
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Neil Horowitz, MD||Dana-Farber Cancer Institute|