Hyperthermic Intraperitoneal Chemotherapy or Intraperitoneal Chemotherapy in Comparing Quality of Life in Patients With Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

PRIMARY OBJECTIVES:

I. To compare quality of life in patients with advanced ovarian cancer treated with
neoadjuvant chemotherapy (NAC) followed by cytoreductive surgery (CRS) with hyperthermic
intraperitoneal chemotherapy (HIPEC) versus NAC followed by CRS and postoperative
intraperitoneal (IP) chemotherapy at 6 weeks post-treatment.

SECONDARY OBJECTIVES:

I. To compare quality of life in patients with advanced ovarian cancer treated with NAC
followed by CRS with HIPEC versus NAC followed by CRS and postoperative IP chemotherapy at 3
and 6 months post-treatment.

II. To compare neurotoxicity in patients with advanced ovarian cancer treated with NAC
followed by CRS with HIPEC versus NAC followed by CRS and postoperative IP chemotherapy III.
To compare abdominal discomfort in patients with advanced ovarian cancer treated with NAC
followed by CRS with HIPEC versus NAC followed by CRS and postoperative IP chemotherapy IV.
To compare toxicities in patients with advanced ovarian cancer treated with NAC followed by
CRS with HIPEC versus NAC followed by CRS and postoperative IP chemotherapy.

V. To compare the response rate in patients with advanced ovarian cancer treated with NAC
followed by CRS with HIPEC versus NAC followed by CRS and postoperative IP chemotherapy.

VI. To compare progression free survival (PFS) in patients with advanced ovarian cancer
treated with NAC followed by CRS with HIPEC versus NAC followed by CRS and postoperative IP
chemotherapy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 60 minutes on days 1, 8, and 15
and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 3
courses in the absence of disease progression or unacceptable toxicity. Beginning 4-8 weeks
after 3 courses of chemotherapy, patients undergo CRS. Beginning 4-8 weeks after CRS,
patients receive paclitaxel IV over 60 minutes on days 1, 8, and 15 and carboplatin
intraperitoneally (IP) over 30-60 minutes on day 1. Treatment repeats every 21 days for up to
3 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive paclitaxel IV over 90 minutes on days 1, 8, and 15 and carboplatin
IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the
absence of disease progression or unacceptable toxicity. Beginning 4-8 weeks after 6 courses
of chemotherapy, patients undergo CRS. Patients then receive carboplatin IP over 120 minutes
immediately following CRS.

After completion of chemotherapy, patients are followed up at 6 weeks, and 3, 6, and 12
months.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed non-mucinous, epithelial
stage 3 or 4 carcinoma of the ovary, fallopian tube or peritoneum

- Patients must not have received treatment for another malignancy within 3 years of
enrollment

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2

- Absolute neutrophil count >= 1,500/mcL

- Platelets >= 100,000/mcL

- Total bilirubin =< 1.5 mg/dL

- Creatinine clearance >= 50 mg/dL

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =<
3 x institutional upper limit of normal

- Alkaline phosphatase =< 3 x institutional upper limit of normal

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and for
the duration of study participation; should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician
immediately

- Ability to understand and the willingness to sign an institutional review board
(IRB)-approved informed consent document (either directly or via a legally authorized
representative)

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier

- Patients may not be receiving any other investigational agents

- Patients with extra-abdominal metastatic disease

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to paclitaxel or carboplatin

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant women are excluded from this study; breastfeeding should be discontinued