Back to resultsOxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma
Primary Purpose
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine
Oxaliplatin
Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring mullerian carcinoma
Eligibility Criteria
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
Sites / Locations
- Massachusetts General Hospital
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chemotherapy
Arm Description
All patients received oxaliplatin, gemcitabine, and bevacizumab
Outcomes
Primary Outcome Measures
Partial Response Rate
Precentage of women who responded to the treatment regimen Response was determined by RECIST criteria
Secondary Outcome Measures
Progression Free Survival
Time participant remains free of progression of her disease. Evaluated by RECIST criteria
Overall Survival
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.
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
Full Information
NCT ID
NCT00418093
First Posted
January 2, 2007
Last Updated
June 18, 2014
Sponsor
Dana-Farber Cancer Institute
Collaborators
Massachusetts General Hospital, Brigham and Women's Hospital, Eli Lilly and Company, Sanofi-Synthelabo, Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00418093
Brief Title
Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma
Official Title
A Phase II Evaluation of Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
THe study was terminated early due to a lack of accural
Study Start Date
September 2006 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Massachusetts General Hospital, Brigham and Women's Hospital, Eli Lilly and Company, Sanofi-Synthelabo, Genentech, Inc.
4. Oversight
5. Study Description
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 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
Keywords
mullerian carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chemotherapy
Arm Type
Experimental
Arm Description
All patients received oxaliplatin, gemcitabine, and bevacizumab
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Partial Response Rate
Description
Precentage of women who responded to the treatment regimen Response was determined by RECIST criteria
Time Frame
Outcome was assessed every 2 cycles (every 8 weeks) for the duration on study, an average of 4.5 cycles (18 weeks)
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
Time participant remains free of progression of her disease. Evaluated by RECIST criteria
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
Title
Overall Survival
Description
Duration of time participants are alive after enrolling on the study. Assessed by clinical records
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
Title
Determine the Nature and Degree of Toxicities Following Treatment With Oxaliplatin, Gemcitabine, and Bevacizumab in This Patient Population.
Description
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
Time Frame
Toxicities were assessed every cycle and for up to 30 days after being removed from the trial
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Horowitz, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma
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