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

NCT01580410 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: IRB00009326NCI-2009-00947CCCWFU 59109
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 3

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.

Conditions

Carcinoma of the Appendix; Primary Peritoneal Cavity Cancer

Outcome Measures

Primary Outcomes (1)

• The Difference in the Number of Grade 3 or 4 Hematologic Toxicities (Leukopenia, Thrombocytopenia, and Neutropenia) Between the Mitomycin C and Oxaliplatin Treatments

  If a patient has a grade 3 or 4 standard hematologic toxicity (leukopenia, thrombocytopenia, and neutropenia), the patient will be considered to be an event. The observed rates of the 2 treatments will be the primary outcome, and the rates will be analyzed using a 2-sided chi-square test.

  Within 4 weeks of surgery

Secondary Outcomes (3)

• The Difference in Percentage of Disease-free Survival Between the Two Treatment Arms up to 3 Years

  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

• The Difference in Percentage of Overall Survival Between the Two Treatment Arms up to 3 Years

  Interval between surgery and death or date of last contact, assessed up to 3 years

• Quality of Life as Assessed by Functional Assessment of Cancer Therapy: General (FACT-G)

  Throughout study completion, up to 3 years

Study Arms (2)

Arm I (mitomycin C)

EXPERIMENTAL

Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.

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

Arm II (oxaliplatin)

EXPERIMENTAL

Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.

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

Interventions

mitomycin C DRUG

Given by HIPEC

Also known as: MITC, MITO, MITO-C, Mitocin-C, MTC

Arm I (mitomycin C)

oxaliplatin DRUG

Given by HIPEC

Also known as: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP

Arm II (oxaliplatin)

therapeutic conventional surgery PROCEDURE

Undergo surgery

Arm I (mitomycin C); Arm II (oxaliplatin)

quality-of-life assessment OTHER

Ancillary studies

Also known as: quality of life assessment

Arm I (mitomycin C); Arm II (oxaliplatin)

hyperthermic intraperitoneal chemotherapy DRUG

Undergo HIPEC

Arm I (mitomycin C); Arm II (oxaliplatin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Appendiceal Neoplasms

Interventions

Mitomycin; Oxaliplatin; Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Cecal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coordination Complexes; Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Limitations and Caveats

The worst adverse event of each type was recorded for the course of treatment.

Results Point of Contact

• Title: Dr. Edward Levine
• Organization: Wake Forest University Health Sciences

elevine@wakehealth.edu

336-716-2763

Study Officials

• Edward Levine

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2012
• First Posted: April 19, 2012
• Study Start: May 1, 2009
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2016
• Last Updated: July 3, 2018
• Results First Posted: March 21, 2018

Record last verified: 2018-06

Locations

US (3)