Phase 2
N=136
Surgery and Oxaliplatin or Mitomycin C in Treating Patients With Tumors of the Appendix
Carcinoma of the Appendix · Primary Peritoneal Cavity Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01580410 ↗Enrolled (actual)
136
Serious AEs
88.2%
Results posted
Mar 2018
Primary outcome: Primary: The Difference in the Number of Grade 3 or 4 Hematologic Toxicities (Leukopenia, Thrombocytopenia, and Neutropenia) Between the Mitomycin C and Oxaliplatin Treatments — 8; 5 number of patients with toxicities
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- mitomycin C (Drug); oxaliplatin (Drug); therapeutic conventional surgery (Procedure); quality-of-life assessment (Other); hyperthermic intraperitoneal chemotherapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Difference in the Number of Grade 3 or 4 Hematologic Toxicities (Leukopenia, Thrombocytopenia, and Neutropenia) Between the Mitomycin C and Oxaliplatin Treatments |
8; 5 | — |
| SECONDARY The Difference in Percentage of Disease-free Survival Between the Two Treatment Arms up to 3 Years |
61.6; 59.4 | — |
| SECONDARY The Difference in Percentage of Overall Survival Between the Two Treatment Arms up to 3 Years |
75.7; 79.3 | — |
| SECONDARY Quality of Life as Assessed by Functional Assessment of Cancer Therapy: General (FACT-G) |
85.5; 89.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients must have histologically or cytologically confirmed peritoneal surface malignancies from primary appendiceal tumors
- Eastern Cooperative Oncology Group (ECOG) performance status = = 1,500/mcL
- Platelets >=100,000/mcL
- Total bilirubin = = 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 = grade 2
- History of allogenic transplant
- History of prior HIPEC
- Evidence of metastatic disease outside of the abdomen
Data sourced from ClinicalTrials.gov (NCT01580410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.