Clinical trial NCT01580410: Surgery and Oxaliplatin or Mitomycin C in Treating Patients With Tumors of the Appendix
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma of the Appendix
Primary Peritoneal Cavity Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-04-19
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: The Difference in the Number of Grade 3 or 4 Hematologic Toxicities (Leukopenia, Thrombocytopenia, and Neutropenia) Between the Mitomycin C and Oxaliplatin Treatments
timeFrame: Within 4 weeks of surgery
Secondary outcomes:
measure: The Difference in Percentage of Disease-free Survival Between the Two Treatment Arms up to 3 Years
timeFrame: 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
measure: The Difference in Percentage of Overall Survival Between the Two Treatment Arms up to 3 Years
timeFrame: Interval between surgery and death or date of last contact, assessed up to 3 years
measure: Quality of Life as Assessed by Functional Assessment of Cancer Therapy: General (FACT-G)
timeFrame: Throughout study completion, up to 3 years
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: Wake Forest University Health Sciences
name: Edward Levine
role: PRINCIPAL_INVESTIGATOR
References: