NCT01580410

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Carcinoma of the Appendix
• Primary Peritoneal Cavity Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-05-01
• Primary completion: 2015-10-01
• Completion: 2016-11-01
• First posted: 2012-04-19
• Last updated: 2018-07-03
• Results posted: 2018-03-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study