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Trial record 10 of 533 for:    "Primary Peritoneal Carcinoma"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00582205
Recruitment Status : Terminated (Study completed per investigator.)
First Posted : December 28, 2007
Results First Posted : May 18, 2017
Last Update Posted : July 2, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma Uterine Cancer Drug: Paclitaxel, Cisplatin IP Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2006
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
Experimental: Paclitaxel, Cisplatin IP
There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy
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

Primary Outcome Measures :
  1. Number of Patients Who Are Able to Receive 6 Cycles of Intraperitoneal Cisplatin Chemotherapy. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Number of Patients With Dose Reductions or Dose Delays Due to Neuropathy or Toxicity [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00582205

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United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
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Principal Investigator: Joan Walker, MD University of Oklahoma

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Responsible Party: University of Oklahoma Identifier: NCT00582205     History of Changes
Other Study ID Numbers: WalkerIP
First Posted: December 28, 2007    Key Record Dates
Results First Posted: May 18, 2017
Last Update Posted: July 2, 2017
Last Verified: June 2017
Keywords provided by University of Oklahoma:
Primary Peritoneal Carcinoma
Ovarian Cancer
Fallopian Tube Cancer
Uterine Cancer
Intraperitoneal Chemotherapy
IP Chemotherapy
Gynecologic Cancer
Women's Cancer
Recurrent Platinum Sensitive Ovarian Cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Uterine Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Uterine Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action