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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Uterine Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the proportion of patients who are able to receive 6 cycles of intraperitoneal cisplatin chemotherapy.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Joan Walker, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Oklahoma

Authority:

United States: Food and Drug Administration

Study ID:

WalkerIP

NCT ID:

NCT00582205

Start Date:

January 2006

Completion Date:

January 2013

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Carcinoma
  • Uterine Cancer
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Carcinoma
  • Uterine Cancer
  • Intraperitoneal Chemotherapy
  • IP Chemotherapy
  • Gynecologic Cancer
  • Women's Cancer
  • Cisplatin
  • Paclitaxel
  • Recurrent Platinum Sensitive Ovarian Cancer
  • Carcinoma
  • Ovarian Neoplasms
  • Uterine Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104