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

Primary Purpose

Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Paclitaxel, Cisplatin IP
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring 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

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • University of Oklahoma Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paclitaxel, Cisplatin IP

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Patients Who Are Able to Receive 6 Cycles of Intraperitoneal Cisplatin Chemotherapy.

Secondary Outcome Measures

Number of Patients With Dose Reductions or Dose Delays Due to Neuropathy or Toxicity

Full Information

First Posted
December 19, 2007
Last Updated
April 28, 2021
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT00582205
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
Study completed per investigator.
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paclitaxel, Cisplatin IP
Arm Type
Experimental
Arm Description
There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy
Intervention Type
Drug
Intervention Name(s)
Paclitaxel, Cisplatin IP
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Patients Who Are Able to Receive 6 Cycles of Intraperitoneal Cisplatin Chemotherapy.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Number of Patients With Dose Reductions or Dose Delays Due to Neuropathy or Toxicity
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Walker, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

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

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