Clinical trial NCT00582205: Feasibility Trial of Intraperitoneal Chemotherapy for Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Uterine Cancer
Keywords: 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
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2007-12-28
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Patients Who Are Able to Receive 6 Cycles of Intraperitoneal Cisplatin Chemotherapy.
timeFrame: 3 years
Secondary outcomes:
measure: Number of Patients With Dose Reductions or Dose Delays Due to Neuropathy or Toxicity
timeFrame: 3 years
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Joan Walker, MD
role: PRINCIPAL_INVESTIGATOR
References: