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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Carcinoma of the Appendix; Primary Peritoneal Cavity Cancer	Drug: mitomycin C; Drug: oxaliplatin; Procedure: therapeutic conventional surgery; Other: quality-of-life assessment; Drug: hyperthermic intraperitoneal chemotherapy	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	136 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	May 2009
Actual Primary Completion Date :	October 2015
Actual Study Completion Date :	November 2016

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Arm I (mitomycin C); Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.	Drug: mitomycin C; Given by HIPEC; Other Names: MITC; MITO; MITO-C; Mitocin-C; MTC Procedure: therapeutic conventional surgery; Undergo surgery Other: quality-of-life assessment; Ancillary studies; Other Name: quality of life assessment Drug: hyperthermic intraperitoneal chemotherapy; Undergo HIPEC
Experimental: Arm II (oxaliplatin); Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.	Drug: oxaliplatin; Given by HIPEC; Other Names: 1-OHP; Dacotin; Dacplat; Eloxatin; L-OHP Procedure: therapeutic conventional surgery; Undergo surgery Other: quality-of-life assessment; Ancillary studies; Other Name: quality of life assessment Drug: hyperthermic intraperitoneal chemotherapy; Undergo HIPEC

Outcome Measures

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Primary Outcome Measures :

1. The Difference in the Number of Grade 3 or 4 Hematologic Toxicities (Leukopenia, Thrombocytopenia, and Neutropenia) Between the Mitomycin C and Oxaliplatin Treatments [ Time Frame: Within 4 weeks of surgery ]
   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.

Secondary Outcome Measures :

1. The Difference in Percentage of Disease-free Survival Between the Two Treatment Arms up to 3 Years [ Time Frame: 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 ]
2. The Difference in Percentage of Overall Survival Between the Two Treatment Arms up to 3 Years [ Time Frame: Interval between surgery and death or date of last contact, assessed up to 3 years ]
3. Quality of Life as Assessed by Functional Assessment of Cancer Therapy: General (FACT-G) [ Time Frame: Up to 3 years ]
   The FACT-G (Functional Assessment of Cancer Therapy - General) consists of 27 core items assessing patient well-being in four components: Physical (7 items), Social/Family (7 items), Emotional (6 items), and Functional (7 items). Items are rated on a five-point scale: 0-"not at all", 1- "a little bit", 2-"somewhat", 3- "quite a bit" and 4-"very much". The score of each component is the mean times the number of items in the component. The range of the physical, social/family, and functional components I 0-28 and the range of the emotional component is 0-24. The sum of the component scores creates the overall score which has a range of 0-108. For all component scores and overall score, the higher the score the better the QOL.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Wake Forest University Health Sciences

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Edward Levine	Wake Forest University Health Sciences

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:	NCT01580410 History of Changes
Obsolete Identifiers:	NCT00904267
Other Study ID Numbers:	CCCWFU 59109; NCI-2009-00947 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted:	April 19, 2012
Results First Posted:	March 21, 2018
Last Update Posted:	March 21, 2018
Last Verified:	December 2017

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:

Appendiceal Neoplasms; Cecal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Cecal Diseases	Intestinal Diseases; Oxaliplatin; Mitomycins; Mitomycin; Antineoplastic Agents; Antibiotics, Antineoplastic; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors