Paclitaxel, Bevacizumab And Adjuvant Intraperitoneal Carboplatin in Treating Patients Who Had Initial Debulking Surgery for Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

NCT00079430 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2019-07-22

No results posted yet for this study

Summary

This phase I trial is studying the side effects and best dose of adjuvant intraperitoneal carboplatin when given together with paclitaxel and bevacizumab in treating patients who have undergone debulking surgery for stage II , stage III, or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether carboplatin, paclitaxel, and bevacizumab are more effective than carboplatin and paclitaxel in treating ovarian epithelial or primary peritoneal cancer, or fallopian tube cancer.

Conditions

  • Brenner Tumor
  • Fallopian Tube Cancer
  • Ovarian Clear Cell Cystadenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Mixed Epithelial Carcinoma
  • Ovarian Mucinous Cystadenocarcinoma
  • Ovarian Serous Cystadenocarcinoma
  • Ovarian Undifferentiated Adenocarcinoma
  • Primary Peritoneal Cavity Cancer
  • Stage II Ovarian Epithelial Cancer
  • Stage III Ovarian Epithelial Cancer
  • Stage IV Ovarian Epithelial Cancer

Interventions

PROCEDURE

adjuvant therapy

DRUG

paclitaxel

Given IV

DRUG

carboplatin

Given intraperitoneally

BIOLOGICAL

bevacizumab

Given IV

Sponsors & Collaborators

  • Gynecologic Oncology Group

    collaborator NETWORK
  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Mark Morgan · Gynecologic Oncology Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2011-05-31

Countries

  • United States
  • Japan

Study Locations

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Entities

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 NCT00079430 on ClinicalTrials.gov