A Phase II Evaluation of Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma
18 Years
N/A
Female
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
Trial Information
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
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.
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.
- ECOG 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, NYHA Grade II or greater congestive heart
failure, serious cardiac arrhythmia requiring medication, a history of DVT, 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 CNS 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
TBD
Safety Issue:
No
Principal Investigator
Neil Horowitz, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Institutional Review Board
Study ID:
04-356
NCT ID:
NCT00418093
Start Date:
September 2006
Completion Date:
December 2011
Related Keywords:
- Ovarian Cancer
- Fallopian Tube Cancer
- Primary Peritoneal Cancer
- mullerian carcinoma
- Carcinoma
- Ovarian Neoplasms
- Peritoneal Neoplasms
- Fallopian Tube Neoplasms
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
