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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)

2014-08-27 03:54:18 | BioPortfolio

Summary

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).

Description

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).

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Fallopian Tube Cancer

Intervention

bevacizumab, carboplatin, docetaxel, paclitaxel

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange
California
United States
92868

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:18-0400

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Medical and Biotech [MESH] Definitions

Diseases involving the FALLOPIAN TUBES including neoplasms (FALLOPIAN TUBE NEOPLASMS); SALPINGITIS; tubo-ovarian abscess; and blockage.

Methods for assessing the patency of the fallopian tubes.

Benign or malignant neoplasms of the FALLOPIAN TUBES. They are uncommon. If they develop, they may be located in the wall or within the lumen as a growth attached to the wall by a stalk.

Formation of an artificial opening in a fallopian tube.

A pair of highly specialized muscular canals extending from the UTERUS to its corresponding OVARY. They provide the means for OVUM collection, and the site for the final maturation of gametes and FERTILIZATION. The fallopian tube consists of an interstitium, an isthmus, an ampulla, an infundibulum, and fimbriae. Its wall consists of three histologic layers: serous, muscular, and an internal mucosal layer lined with both ciliated and secretory cells.

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