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
I. 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.
II. Determine the MTD of IP carboplatin and IV docetaxel when given in combination with IP
paclitaxel in these patients.
III. 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).
IV. Determine the dose-limiting toxic effects and complications in patients treated with
V. Evaluate the neurotoxicity of this regimen at each cycle using the FACT/GOG-NTX4
assessment tool to determine dose reduction in these patients.
VI. 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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) of IV paclitaxel with IP carboplatin followed by IP paclitaxel, determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
Gynecologic Oncology Group
United States: Food and Drug Administration
|Johns Hopkins University||Baltimore, Maryland 21205|
|University of Iowa Hospitals and Clinics||Iowa City, Iowa 52242|
|Washington University School of Medicine||Saint Louis, Missouri 63110|
|University of Oklahoma Health Sciences Center||Oklahoma City, Oklahoma 73104|
|Greater Baltimore Medical Center||Baltimore, Maryland 21204|
|Case Western Reserve University||Cleveland, Ohio 44106|
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|
|Cooper Hospital University Medical Center||Camden, New Jersey 08103|
|University of California Medical Center At Irvine-Orange Campus||Orange, California 92868|
|Cancer Care Associates-Yale||Tulsa, Oklahoma 74136-1929|
|Cancer Care Associates-Midtown||Tulsa, Oklahoma 74104|
|Women and Infants Hospital||Providence, Rhode Island 02905|
|Colorado Gynecologic Oncology Group||Aurora, Colorado 80010|
|Lake University Ireland Cancer Center||Mentor, Ohio 44060|
|Gynecologic Oncology Group||Philadelphia, Pennsylvania 19103|
|Cleveland Clinic Cancer Center/Fairview Hospital||Cleveland, Ohio 44111|