Carboplatin and Paclitaxel With or Without Bevacizumab Compared to Docetaxel, Carboplatin, and Paclitaxel in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Carcinoma (Cancer)



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

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A Phase I Trial Of Intravenous Paclitaxel Intraperitoneal Carboplatin And Intraperitoneal Paclitaxel Or Intravenous Docetaxel, Intraperitoneal Carboplatin, And Intraperitoneal Paclitaxel Or Intravenous Paclitaxel, Intraperitoneal Carboplatin, Intraperitoneal Paclitaxel And CTEP-Supplied Agent Bevacizumab (NSC 704865, IND 7921) In Patients With Previously Untreated Ovarian, Fallopian Tube Or Primary Peritoneal Carcinoma


RATIONALE: Drugs used in chemotherapy, such as carboplatin, docetaxel, and paclitaxel, work
in different ways to stop tumor cells from dividing so they stop growing or die. Combining
more than one drug and giving them in different ways may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of intraperitoneal
infusions of carboplatin when given together with intravenous infusions of either docetaxel
or paclitaxel followed by intraperitoneal paclitaxel in treating patients with stage II,
stage III, or stage IV ovarian epithelial, fallopian tube, or primary peritoneal cavity
carcinoma (cancer).


OBJECTIVES:

- Determine the maximum tolerated dose (MTD) of intraperitoneal (IP) carboplatin when
given in combination with IV paclitaxel followed by IP paclitaxel in patients with
stage III or IV ovarian epithelial, fallopian tube, or primary peritoneal cavity
carcinoma.

- Determine the MTD of IP carboplatin and IV docetaxel when given in combination with IP
paclitaxel in these patients.

- To determine the feasibility of the combination of IV paclitaxel, IP carboplatin and IV
bevacizumab on day one followed by IP paclitaxel on day eight (Part C Only).

- Determine the dose-limiting toxic effects and complications in patients treated with
these regimens.

- Evaluate the neurotoxicity of this regimen at each cycle using the FACT/GOG-NTX4
assessment tool to determine dose reduction in these patients.

- Evaluate the techniques used for intraperitoneal catheter placement, surgical
procedures, and reporting of outcomes in these patients.

OUTLINE: This is a multicenter, dose-escalation study of intraperitoneal (IP) carboplatin.
Patients in the dose-escalation phase are not eligible to enter the feasibility phase.

- Dose-escalation phase (Part A or Part B): Patients receive IP carboplatin on day 1, and
paclitaxel IV over 3 hour (part A) or docetaxel IV over 1 hour (Part B)on day 1, and IP
paclitaxel on day 8. Treatment repeats every 21 days for 6 courses in the absence of
disease progression or unacceptable toxicity.

- Feasibility phase (Part C): Patients receive IP carboplatin on day 1, paclitaxel IV on
day 1, and IP paclitaxel on day 8 in course 1 as in part A dose-escalation phase.
Beginning in course 2 and all subsequent courses, patients receive IP carboplatin on
day 1, IV paclitaxel on day 1, and IP paclitaxel on day 8 as in the dose-escalation
phase, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days
for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 3-40 patients will be accrued for this study (3-20 in the
dose-escalation phase and 20 in the feasibility phase).


We found this trial at
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Franklin Twp, New Jersey 08043
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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...
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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...
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Iowa City, IA
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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...
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Providence, RI
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Orange, California 92868
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Orange, CA
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660 S Euclid Ave
St. Louis, Missouri 63110
(800) 600-3606
Siteman Cancer Center The Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University...
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St. Louis, MO
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