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Surgery and Oxaliplatin or Mitomycin C in Treating Patients With Primary Appendiceal Tumor
This study is currently recruiting participants.
Verified January 2012 by Comprehensive Cancer Center of Wake Forest University

First Received on May 15, 2009.   Last Updated on January 5, 2012   History of Changes
Sponsor: Comprehensive Cancer Center of Wake Forest University
Information provided by: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT00904267
  Purpose

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and mytomycin 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.

PURPOSE: 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 primary colorectal tumors or tumors of the appendix.


Condition Intervention Phase
Peritoneal Cavity Cancer
Drug: mitomycin C
Drug: oxaliplatin
Procedure: therapeutic conventional surgery
Other: quality-of-life assessment
Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label, Randomized Phase II Trial to Evaluate Hematologic Toxicities After Hyperthermic Intraperitoneal Chemotherapy (HIPEC)With Oxaliplatin or Mitomycin C in Patients With Primary Appendiceal Tumors.

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • A comparison between the rate of toxicities observed in the treatment arms [ Time Frame: Within 4 weeks of surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disease-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Quality of life, as assessed by FACT-G [ Time Frame: 3,6,12,18,24,30,36 months after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 116
Study Start Date: May 2009
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients undergo surgical cytoreduction and receive mitomycin C by Hyperthermic Intraperitoneal Chemotherapy(HIPEC).
Drug: mitomycin C
Given by Hyperthermic Intraperitoneal Chemotherapy(HIPEC)
Other Name: MITC, MITO, MITO-C, MTC, Mitocin-C, Mutamycin, mitomycin-C, NCI-C04706
Procedure: therapeutic conventional surgery Other: quality-of-life assessment
Other Name: quality of life assessment
Experimental: Arm II
Patients undergo surgical cytoreduction and receive oxaliplatin by Hyperthermic Intraperitoneal Chemotherapy(HIPEC).
Drug: oxaliplatin
Given by Hyperthermic Intraperitoneal Chemotherapy(HIPEC)
Other Name: Eloxatin, L-OHP, 1-OHP, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatine, JM-83, Oxalatoplatin, Oxalatoplatinum, RP-54780, SR-96669, [(1R,-2R)-1,
Procedure: therapeutic conventional surgery Other: quality-of-life assessment
Other Name: quality of life assessment

Detailed Description:

Primary Objectives: I. To compare the toxicity profiles within 4 weeks of surgery of oxaliplatin and mitomycin C delivered via intraperitoneal hyperthermic chemoperfusion in patients with peritoneal surface malignancies from primary colorectal and appendiceal tumors.

Secondary Objectives: I. To compare the time to progression in patients treated with oxaliplatin vs. mitomycin C delivered via intraperitoneal hyperthermic chemoperfusion for surface malignancies from primary colorectal and appendiceal tumors.

OUTLINE: This multicenter, open-label, randomized phase II study. 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 Hyperthermic Intraperitoneal Chemotherapy(HIPEC).

After completion of study treatment, patients are followed at 6, 12, 18, 24, 30, and 36 months.

PROJECTED ACCURAL: A total of 116 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed peritoneal surface malignancies from primary colorectal and appendiceal tumors
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Please contact study investigator and/or consult protocol document for specific details on laboratory criteria
  • 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 or abstinence) for the duration of study participation and for 90 days following Hyperthermic Intraperitoneal Chemotherapy(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 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 Hyperthermic Intraperitoneal Chemotherapy(HIPEC) (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
  • Patients with carcinoid tumors
  • Patients with active 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 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
  • Known HIV-, hepatitis B-, or hepatitis C-positive patients (active, previously treated, or both)
  • Peripheral neuropathy >= grade 2
  • History of allogenic transplant
  • History of prior Hyperthermic Intraperitoneal Chemotherapy(HIPEC)
  • Evidence of metastatic disease outside of the abdomen
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00904267

Contacts
Contact: Joyce Fenstermaker, RN 336-713-3155

Locations
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: John H. Stewart IV     336-716-9377     jhstewar@wfubmc.edu    
Principal Investigator: John H. Stewart IV            
United States, Pennsylvania
UPMC Hillman Cancer Center Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: David L. Bartlett     412-692-2852     bartlettdl@msx.upmc.edu    
Principal Investigator: David L. Bartlett            
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Paul Fu Mansfield     713-794-5499     pmansfie@notes.mdacc.tmc.edu    
Principal Investigator: Paul Fu Mansfield            
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: John H Stewart IV Wake Forest University
  More Information

No publications provided

Responsible Party: Stewart, John H. IV, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00904267     History of Changes
Other Study ID Numbers: NCI-2009-00947, CCCWFU 59109
Study First Received: May 15, 2009
Last Updated: January 5, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peritoneal Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Mitomycins
Mitomycin
Oxaliplatin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents

ClinicalTrials.gov processed this record on February 09, 2012