Fallopian Tube Cancer Clinical Trial
Official title:
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
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). 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
OBJECTIVES:
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
these regimens.
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.
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