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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Partial Response Rate
Secondary Outcome
Progression Free Survival
Condition
Ovarian Cancer
Intervention
Gemcitabine
Study Arms / Comparison Groups
Chemotherapy
Description: All patients received oxaliplatin, gemcitabine, and bevacizumab
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
19
Start Date
September 2006
Completion Date
October 2011
Primary Completion Date
January 2011
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Neil Horowitz, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00418093
Organization ID
04-356
Responsible Party
Principal Investigator
Study Sponsor
Dana-Farber Cancer Institute
Collaborators
Massachusetts General Hospital
Study Sponsor
Neil Horowitz, MD, Principal Investigator, Dana-Farber Cancer Institute
Verification Date
June 2014