Loading clinical trials...

Surgery and Oxaliplatin or Mitomycin C in Treating Patients With Tumors of the Appendix | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT01580410•Wake Forest University Health Sciences

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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
+2 more criteria

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)
+4 more criteria

Locations (3)

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

Key Dates

Start Date

May 1, 2009

Primary Completion Date

October 1, 2015

Completion Date

November 1, 2016

Last Updated

July 3, 2018

Enrollment

136

ACTUAL participants

Conditions

Carcinoma of the AppendixPrimary Peritoneal Cavity Cancer

Interventions

mitomycin C

DRUG

oxaliplatin

DRUG

therapeutic conventional surgery

PROCEDURE

quality-of-life assessment

OTHER

hyperthermic intraperitoneal chemotherapy

DRUG

Intraperitoneal FT536 in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

NCT06342986

Gynecologic CancerOvarian Cancer+2 more

View study

RECRUITINGPHASE1

A Study of XMT-1660 in Participants With Solid Tumors

NCT05377996

Triple Negative Breast CancerBreast Cancer+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Intraperitoneal FT536 in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

A Study of XMT-1660 in Participants With Solid Tumors

Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Paclitaxel and Ganetespib in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Vaccine Therapy, Paclitaxel, and Carboplatin in Treating Patients Who Are Undergoing Surgery for Stage III or Stage IV Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer