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Surgery and Oxaliplatin or Mitomycin C in Treating Patients With Tumors of the Appendix

NCT01580410 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2018-07-03

Study results available
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Summary

This randomized phase II trial is studying the side effects and how well giving oxaliplatin or mitomycin C directly into the abdomen after surgery works in treating patients with tumors of the appendix. Drugs used in chemotherapy, such as oxaliplatin and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Heating a chemotherapy solution and infusing it directly into the abdomen may kill more tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

Conditions

  • Carcinoma of the Appendix
  • Primary Peritoneal Cavity Cancer

Interventions

DRUG

mitomycin C

Given by HIPEC

DRUG

oxaliplatin

Given by HIPEC

PROCEDURE

therapeutic conventional surgery

Undergo surgery

OTHER

quality-of-life assessment

Ancillary studies

DRUG

hyperthermic intraperitoneal chemotherapy

Undergo HIPEC

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Edward Levine · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2015-10-31
Completion
2016-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01580410 on ClinicalTrials.gov