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

NCT ID: NCT01580410

Last Updated: 2018-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2016-11-30

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.

Conditions

Carcinoma of the Appendix; Primary Peritoneal Cavity Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I (mitomycin C)

Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.

Group Type: EXPERIMENTAL

mitomycin C

Intervention Type: DRUG

Given by HIPEC

therapeutic conventional surgery

Intervention Type: PROCEDURE

Undergo surgery

quality-of-life assessment

Intervention Type: OTHER

Ancillary studies

hyperthermic intraperitoneal chemotherapy

Intervention Type: DRUG

Undergo HIPEC

Arm II (oxaliplatin)

Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.

Group Type: EXPERIMENTAL

oxaliplatin

Intervention Type: DRUG

Given by HIPEC

therapeutic conventional surgery

Intervention Type: PROCEDURE

Undergo surgery

quality-of-life assessment

Intervention Type: OTHER

Ancillary studies

hyperthermic intraperitoneal chemotherapy

Intervention Type: DRUG

Undergo HIPEC

Interventions

mitomycin C

Given by HIPEC

Intervention Type: DRUG

oxaliplatin

Given by HIPEC

Intervention Type: DRUG

therapeutic conventional surgery

Undergo surgery

Intervention Type: PROCEDURE

quality-of-life assessment

Ancillary studies

Intervention Type: OTHER

hyperthermic intraperitoneal chemotherapy

Undergo HIPEC

Intervention Type: DRUG

Other Intervention Names

MITC; MITO; MITO-C; Mitocin-C; MTC; 1-OHP; Dacotin; Dacplat; Eloxatin; L-OHP; quality of life assessment

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward Levine

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

NCI-2009-00947

Identifier Type: REGISTRY

Identifier Source: secondary_id

CCCWFU 59109

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00009326

Identifier Type: -

Identifier Source: org_study_id

NCT00904267

Identifier Type: -

Identifier Source: nct_alias