MedTrace Logo

Intraperitoneal vs Intravenous Chemotherapy Following Neoadjuvant Chemotherapy in Ovarian Cancer

NCT00993655 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2023-08-28

Study results available
· View outcomes & findings →

Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, carboplatin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating patients with ovarian epithelial cancer, primary peritoneal cancer, and fallopian tube cancer.

PURPOSE: This randomized phase II trial is comparing the side effects of three combination chemotherapy regimens and to see how well they work in treating patients with stage IIB, stage IIC, stage III, or stage IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.

Conditions

Interventions

DRUG

carboplatin

Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.

DRUG

cisplatin

Cisplatin 75 mg/m2 intraperitoneal day 1

DRUG

paclitaxel

Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Grupo Español de Investigación en Cáncer de Ovario

    collaborator OTHER

  • Cancer Research UK

    collaborator OTHER

  • SWOG Cancer Research Network

    collaborator NETWORK

  • Canadian Cancer Trials Group

    lead NETWORK

Principal Investigators

  • Helen J. Mackay, MD · Princess Margaret Hospital, Canada

  • Diane M. Provencher, MD, FRCS, FACOG · Hopital Notre-Dame du CHUM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-03
Primary Completion
2016-03-10
Completion
2016-07-11
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00993655 on ClinicalTrials.gov