A Phase II Evaluation of Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma
- 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
- 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
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Estimate the progression free survival and time to tumor progression, response rate, and duration of response following treatment with oxaliplatin, gemcitabine and bevacizumab in this patient population.
Neil Horowitz, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|