Trial record 9 of 1276 for:
Uterine Cancer: Clinical Trials
Feasibility Trial of Intraperitoneal Chemotherapy for Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma
This study is ongoing, but not recruiting participants.
Sponsor:
University of Oklahoma
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00582205
First received: December 19, 2007
Last updated: October 26, 2011
Last verified: October 2011
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Purpose
The purpose of this study is to evaluate giving chemotherapy drugs directly into the abdomen (belly) along with intravenous administration.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma Uterine Cancer |
Drug: Paclitaxel, Cisplatin IP |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by University of Oklahoma:
Primary Outcome Measures:
- To determine the proportion of patients who are able to receive 6 cycles of intraperitoneal cisplatin chemotherapy. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To determine the frequency of dose reductions or dose delays due to neuropathy; To determine the frequency of dose reductions or dose delays due to metabolic, renal, or nausea and vomiting toxicity [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00582205
Locations
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
Sponsors and Collaborators
University of Oklahoma
Investigators
| Principal Investigator: | Joan Walker, MD | University of Oklahoma |
More Information
No publications provided
| Responsible Party: | University of Oklahoma |
| ClinicalTrials.gov Identifier: | NCT00582205 History of Changes |
| Other Study ID Numbers: | WalkerIP |
| Study First Received: | December 19, 2007 |
| Last Updated: | October 26, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Oklahoma:
|
Ovarian Cancer Fallopian Tube Cancer Uterine Cancer Gynecologic Cancer Women's Cancer Recurrent Platinum Sensitive Ovarian Cancer |
Primary Peritoneal Carcinoma Intraperitoneal Chemotherapy IP Chemotherapy Cisplatin Paclitaxel |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Uterine Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Genital Neoplasms, Female Urogenital Neoplasms Uterine Diseases Carcinoma Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
Endocrine System Diseases Gonadal Disorders Fallopian Tube Diseases Cisplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 17, 2013