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

Status:	Archived
Conditions:	Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	May 2009

A Multi-Center, Open-Label, Randomized Phase II Trial to Evaluate Hematologic Toxicities After IPHC With Oxaliplatin or Mitomycin C in Patients With Primary Colorectal or Appendiceal Tumors

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and mytomycin 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.

PURPOSE: 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 primary colorectal tumors or tumors of the appendix.

Primary Objectives: I. To compare the toxicity profiles within 4 weeks of surgery of
oxaliplatin and mitomycin C delivered via intraperitoneal hyperthermic chemoperfusion in
patients with peritoneal surface malignancies from primary colorectal and appendiceal
tumors.

Secondary Objectives: I. To compare the time to progression in patients treated with
oxaliplatin vs. mitomycin C delivered via intraperitoneal hyperthermic chemoperfusion for
surface malignancies from primary colorectal and appendiceal tumors.

OUTLINE: This multicenter, open-label, randomized phase II study. Patients are randomized to
1 of 2 treatment arms. Arm I: Patients undergo surgical cytoreduction and receive mitomycin
C by intraperitoneal hyperthermic chemotherapy (IPHC).

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

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

PROJECTED ACCURAL: A total of 116 patients will be accrued for this study.

We found this trial at

sites

Wake Forest University Baptist Medical Center

1 Medical Center Blvd
Winston-Salem, North Carolina 27103

(336) 716-2011