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

Phase 2

Terminated

• Conditions: Fallopian Tube Cancer; Primary Peritoneal Carcinoma; Ovarian Cancer; Uterine Cancer
• Interventions: Drug: Paclitaxel, Cisplatin IP

• Registration Number: NCT00582205
• Lead Sponsor: University of Oklahoma

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-27
• Study First Posted: 2007-12-28
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2017-04-12
• Results First Submitted QC: 2017-04-12
• Results First Posted: 2017-05-18
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel, Cisplatin IP	Paclitaxel, Cisplatin IP	There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy

Primary Outcome Measures

Name	Time	Method
Number of Patients Who Are Able to Receive 6 Cycles of Intraperitoneal Cisplatin Chemotherapy.	3 years

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Dose Reductions or Dose Delays Due to Neuropathy or Toxicity	3 years

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States