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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
136
Given by HIPEC
Given by HIPEC
Undergo surgery
Ancillary studies
Undergo HIPEC
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
M D Anderson Cancer Center
Houston, Texas, United States
The Difference in the Number of Grade 3 or 4 Hematologic Toxicities (Leukopenia, Thrombocytopenia, and Neutropenia) Between the Mitomycin C and Oxaliplatin Treatments
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.
Time frame: Within 4 weeks of surgery
The Difference in Percentage of Disease-free Survival Between the Two Treatment Arms up to 3 Years
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
The Difference in Percentage of Overall Survival Between the Two Treatment Arms up to 3 Years
Time frame: Interval between surgery and death or date of last contact, assessed up to 3 years
Quality of Life as Assessed by Functional Assessment of Cancer Therapy: General (FACT-G)
The FACT-G (Functional Assessment of Cancer Therapy - General) consists of 27 core items assessing patient well-being in four components: Physical (7 items), Social/Family (7 items), Emotional (6 items), and Functional (7 items). Items are rated on a five-point scale: 0-"not at all", 1- "a little bit", 2-"somewhat", 3- "quite a bit" and 4-"very much". The score of each component is the mean times the number of items in the component. The range of the physical, social/family, and functional components I 0-28 and the range of the emotional component is 0-24. The sum of the component scores creates the overall score which has a range of 0-108. For all component scores and overall score, the higher the score the better the QOL.
Time frame: Throughout study completion, up to 3 years
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