Paclitaxel, Bevacizumab And Adjuvant Intraperitoneal Carboplatin in Treating Patients Who Had Initial Debulking Surgery for Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer



Status:Archived
Conditions:Ovarian Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011

Use our guide to learn which trials are right for you!

A Dose Escalating Phase I Study With An Expanded Cohort To Assess The Feasibility Of Intraperitoneal Carboplatin (NSC #214240) And Intravenous Paclitaxel (NSC # 673089) And Intravenous Paclitaxel, Intraperitoneal Carboplatin And NCI Supplied Intravenous Bevacizumab (NSC #704865,IND #7921) In Patients With Previously Untreated Epithelial Ovarian, Primary Peritoneal, Or Fallopian Tube Carcinoma


RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different
ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies,
such as bevacizumab, can block tumor growth in different ways. Some block the ability of
tumor cells to grow and spread. Others find tumor cells and help kill them or carry
tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by
blocking blood flow to the tumor. It is not yet known whether carboplatin, paclitaxel, and
bevacizumab are more effective than carboplatin and paclitaxel in treating ovarian
epithelial or primary peritoneal cancer, or fallopian tube cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of adjuvant
intraperitoneal carboplatin when given together with paclitaxel and bevacizumab in treating
patients who have undergone debulking surgery for stage II , stage III, or stage IV ovarian
epithelial, primary peritoneal, or fallopian tube cancer.


OBJECTIVES:

Primary

- Determine the maximum tolerated dose of intraperitoneal carboplatin when administered
with paclitaxel during course 1, in patients with stage II-IV ovarian epithelial,
primary peritoneal, or fallopian tube cancer who had initial debulking surgery.

- Determine the feasibility of this regimen in these patients.

- Determine the feasibility of adding IV bevacizumab to this regimen in courses 2-6.

Secondary

- Determine the toxicity profile of this regimen in these patients.

- Determine the toxicity profile of paclitaxel and bevacizumab IV in combination with
intraperitoneal carboplatin in these patients.

- Determine the response rate (in patients with measurable disease who are in the
expanded cohort) and progression-free survival of patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of intraperitoneal carboplatin.

Patients receive paclitaxel IV over 3 hours followed by intraperitoneal carboplatin over 15
minutes on day 1 in course 1. Beginning in course 2, patients also receive bevacizumab IV
over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the
absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of carboplatin until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional
20-40 patients are treated at that dose level.

Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 3-64 patients (3-24 for dose escalation and 20-40 for
feasibility) will be accrued for this study within 15 months.


We found this trial at
10
sites
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
200 Hawkins Drive
Iowa City, Iowa 52242
800-237-1225
Holden Comprehensive Cancer Center at University of Iowa Holden Comprehensive Cancer Center is dedicated to...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
800 NE 10th Street
Oklahoma City, Oklahoma 73104
(855) 750-2273
Oklahoma University Cancer Institute The Peggy and Charles Stephenson Cancer Center is located on the...
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
1959 NE Pacific St
Seattle, Washington 98195
(206) 598-4100
University Cancer Center at University of Washington Medical Center The Division of Radiation Oncology's work...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Franklin Twp, New Jersey 08043
?
mi
from
Franklin Twp, NJ
Click here to add this to my saved trials
Orange, California 92868
?
mi
from
Orange, CA
Click here to add this to my saved trials
333 Cottman Ave
Philadephia, Pennsylvania 19111
(215) 728-6900
Fox Chase Cancer Center Fox Chase has earned the prestigious designation from the National Cancer...
?
mi
from
Philadephia, PA
Click here to add this to my saved trials