Feasibility Trial of Intraperitoneal Chemotherapy for Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma

University of Oklahoma (OU)

Status and phase: Terminated; Phase 2

Conditions: Uterine Cancer; Primary Peritoneal Carcinoma; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Drug: Paclitaxel, Cisplatin IP

Study type: Interventional

Funder types: Other

Identifiers

NCT00582205

WalkerIP

Details and patient eligibility

About

The purpose of this study is to evaluate giving chemotherapy drugs directly into the abdomen (belly) along with intravenous administration.

Full description

Giving chemotherapy directly into the abdomen is called intraperitoneal (IP) chemotherapy. Because ovarian, fallopian, primary peritoneal and uterine cancer spread in the abdominal cavity, giving chemotherapy drugs by infusion into the abdominal cavity may result in a greater dose of the drugs reaching the tumor cells. Intraperitoneal treatments will be administered through an implantable peritoneal catheter. These catheters are to be inserted into the peritoneal cavity, tunneled through the subcutaneous tissue, and connected to an implantable port, which is placed in the subcutaneous tissue of the anterior, inferior thorax.

Enrollment: 21 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with stage IA, IB, IC, II, III, IV and recurrent platinum sensitive epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma, or ovarian carcinosarcoma. Histologic subtypes which are eligible include serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's tumor, adenocarcinoma (not otherwise specified), and carcinosarcoma.
• Patients with advanced endometrial carcinoma, of any histology, including endometrioid adenocarcinoma, clear cell adenocarcinoma, and serous papillary carcinoma.
• Patients with uterine carcinosarcoma of any stage are eligible.

Exclusion criteria

• Patients with epithelial ovarian carcinoma of low malignant potential (borderline carcinomas).
• Patients with septicemia, severe infection, or acute hepatitis.
• Patients with prior malignancy or cancer treatment within the last five years.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Paclitaxel, Cisplatin IP

Experimental group

Description:

There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy

Treatment:

Drug: Paclitaxel, Cisplatin IP