Surgery and Oxaliplatin or Mitomycin C in Treating Patients With Tumors of the Appendix
Condition: Carcinoma of the Appendix; Primary Peritoneal Cavity Cancer
MeSH terms: Peritoneal Neoplasms
Intervention: mitomycin C; oxaliplatin; therapeutic conventional surgery; quality-of-life assessment; hyperthermic intraperitoneal chemotherapy
Intervention description: Given by HIPEC; Given by HIPEC; Undergo surgery; Ancillary studies; Undergo HIPEC
Intervention MeSH terms: Oxaliplatin; Mitomycins; Mitomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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 =< 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