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

NCT00582205 | Terminated Phase 2 Results

• 1 other identifier: WalkerIP
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate giving chemotherapy drugs directly into the abdomen (belly) along with intravenous administration.

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

Outcome Measures

Primary Outcomes (1)

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

  3 years

Secondary Outcomes (1)

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

  3 years

Study Arms (1)

Paclitaxel, Cisplatin IP

EXPERIMENTAL

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

Drug: Paclitaxel, Cisplatin IP

Interventions

Paclitaxel, Cisplatin IP DRUG

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

Paclitaxel, Cisplatin IP

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Uterine Neoplasms

Interventions

TP protocol

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Uterine Diseases

Results Point of Contact

• Title: Dr. Joan Walker
• Organization: University of Oklahoma

joan-walker@ouhsc.edu

405-271-8707

Study Officials

• Joan Walker, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 28, 2007
• Study Start: January 1, 2006
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 19, 2021
• Results First Posted: May 18, 2017

Record last verified: 2021-04

Locations

US (1)