Surgery and Oxaliplatin or Mitomycin C in Treating Patients With Tumors of the Appendix

Wake Forest University (WFU)

Status and phase: Completed; Phase 2

Conditions: Primary Peritoneal Cavity Cancer; Carcinoma of the Appendix

Treatments: Drug: hyperthermic intraperitoneal chemotherapy; Drug: mitomycin C; Other: quality-of-life assessment; Procedure: therapeutic conventional surgery; Drug: oxaliplatin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01580410

NCI-2009-00947 (Registry Identifier)

IRB00009326

CCCWFU 59109 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Arm I (mitomycin C)

Experimental group

Description:

Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.

Treatment:

Procedure: therapeutic conventional surgery

Other: quality-of-life assessment

Drug: hyperthermic intraperitoneal chemotherapy

Drug: mitomycin C

Arm II (oxaliplatin)

Experimental group

Description:

Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.

Treatment:

Drug: oxaliplatin

Procedure: therapeutic conventional surgery

Other: quality-of-life assessment

Drug: hyperthermic intraperitoneal chemotherapy