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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Multi-Center, Open-Label, Randomized Phase II Trial to Evaluate Hematologic Toxicities After HIPEC With Oxaliplatin or Mitomycin C in Patients With Appendiceal Tumors

Brief 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.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To compare the toxicity profiles within 4 weeks of surgery of oxaliplatin and mitomycin C delivered via Hyperthermic Intraperitoneal Chemotherapy in patients with peritoneal surface malignancies from primary appendiceal tumors.

SECONDARY OBJECTIVES:

I. To compare the time to progression in patients treated with oxaliplatin vs. mitomycin C delivered via Hyperthermic Intraperitoneal Chemotherapy for surface malignancies from primary appendiceal tumors.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients undergo surgical cytoreduction and receive mitomycin C by hyperthermic intraperitoneal chemotherapy (HIPEC).

Arm II: Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.

After completion of study treatment, patients are followed up at 6, 12, 18, 24, 30, and 36 months.


Sponsor: Wake Forest University Health Sciences

Current Primary Outcome: Difference in the rate of grade 3 or 4 hematologic toxicities (leukopenia, thrombocytopenia, and neutropenia) between the mitomycin C and oxaliplatin treatments [ Time Frame: Within 4 weeks of surgery ]

If a patient has a grade 3 or 4 standard hematologic toxicity (leukopenia, thrombocytopenia, and neutropenia), the patient will be considered to be an event. The observed rates of the 2 treatments will be the primary outcome, and the rates will be analyzed using a 2-sided chi-square test.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Comparison of disease-free survival between the two treatment arms [ Time Frame: Time to first progression unless the patient's resection status is R2b or 2c, regardless of toxicity or response to study drug, assessed up to 3 years ]
  • Comparison of overall survival between the two treatment arms [ Time Frame: Interval between surgery and death or date of last contact, assessed up to 3 years ]
  • Quality of life as assessed by FACT-G [ Time Frame: Up to 3 years ]


Original Secondary Outcome: Same as current

Information By: Wake Forest University Health Sciences

Dates:
Date Received: April 17, 2012
Date Started: May 2009
Date Completion: November 2016
Last Updated: December 28, 2015
Last Verified: December 2015