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

Ovarian Cancer Clinical Trial

Official title:

Feasibility Trial of Intraperitoneal Chemotherapy in Stage IA, IB, IC, II, III, IV and Recurrent Platinum Sensitive Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma and Stage III and IV Uterine Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00582205
• Other study ID #: WalkerIP
• Status: Terminated
• Phase: Phase 2
• Start date: January 2006
• Est. completion date: December 2011

Study information

• Verified date: April 2021
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Ovarian Epithelial
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma
• Uterine Cancer
• Uterine Neoplasms

Intervention

Drug:
• Paclitaxel, Cisplatin IP
Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Who Are Able to Receive 6 Cycles of Intraperitoneal Cisplatin Chemotherapy.		3 years
Secondary	Number of Patients With Dose Reductions or Dose Delays Due to Neuropathy or Toxicity		3 years