Overview

This trial is active, not recruiting.

Conditions carcinoma of the appendix, primary peritoneal cavity cancer
Treatments mitomycin c, oxaliplatin, therapeutic conventional surgery, quality-of-life assessment, hyperthermic intraperitoneal chemotherapy
Phase phase 2
Sponsor Comprehensive Cancer Center of Wake Forest University
Collaborator National Cancer Institute (NCI)
Start date May 2009
End date October 2015
Trial size 116 participants
Trial identifier NCT01580410, CCCWFU 59109, NCI-2009-00947, NCT00904267

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.
mitomycin c MITC
Given by HIPEC
therapeutic conventional surgery
Undergo surgery
quality-of-life assessment quality of life assessment
Ancillary studies
hyperthermic intraperitoneal chemotherapy
Undergo HIPEC
(Experimental)
Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.
oxaliplatin 1-OHP
Given by HIPEC
therapeutic conventional surgery
Undergo surgery
quality-of-life assessment quality of life assessment
Ancillary studies
hyperthermic intraperitoneal chemotherapy
Undergo HIPEC

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients must have histologically or cytologically confirmed peritoneal surface malignancies from primary appendiceal tumors - Eastern Cooperative Oncology Group (ECOG) performance status =< 2 - Absolute neutrophil count >= 1,500/mcL - Platelets >=100,000/mcL - Total bilirubin =< 1.5 mg/dL - Creatinine =< 2.0 mg/dL - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 X institutional upper limit of normal - Alkaline phosphatase =< 3 X institutional upper limit of normal - Patients must be recovered from both the acute and late effects of any prior surgery, radiotherapy, or other antineoplastic therapy - Women of child-bearing potential and men must agree to use adequate contraception (hormonal or double-barrier method of birth control; abstinence) for the duration of study participation and for 90 days following HIPEC - Ability to understand and the willingness to sign a written informed consent document (either directly or via a legally authorized representative) - Participants who have received oxaliplatin during prior systemic chemotherapy regimens are eligible for enrollment in this protocol Exclusion Criteria: - Patients with an active infection or with a fever >= 101.3 degrees Fahrenheit (F) within 3 days of the first scheduled day of protocol treatment - Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of HIPEC (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication) - Patients with carcinoid tumors - Patients with active central nervous system (CNS) metastases - Patients with known hypersensitivity to any of the components of oxaliplatin or mitomycin C - History of prior malignancy within the past 5 years, except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current prostate-specific antigen (PSA) of < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry - Patients who received radiotherapy to more than 25% of their bone marrow - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Pregnant/nursing women are excluded from this study because oxaliplatin is an agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with oxaliplatin, breastfeeding should be discontinued if the mother is treated with oxaliplatin or mitomycin C - Known human immunodeficiency virus (HIV), hepatitis B or C-positive patients (active, previously treated or both) - Peripheral neuropathy >= grade 2 - History of allogenic transplant - History of prior HIPEC - Evidence of metastatic disease outside of the abdomen

Additional Information

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
Principal investigator Edward Levine
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Comprehensive Cancer Center of Wake Forest University.
Location data was received from the National Cancer Institute and was last updated in September 2016.