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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01580410
First received: April 17, 2012
Last updated: July 21, 2014
Last verified: July 2014

April 17, 2012
July 21, 2014
May 2009
May 2015   (final data collection date for primary outcome measure)
Difference in the rate 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 ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01580410 on ClinicalTrials.gov Archive Site
  • Comparison of disease-free survival between the two treatment arms [ 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 ] [ Designated as safety issue: No ]
  • Comparison of overall survival between the two treatment arms [ Time Frame: Interval between surgery and death or date of last contact, assessed up to 3 years ] [ Designated as safety issue: No ]
  • Quality of life as assessed by FACT-G [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Carcinoma of the Appendix
  • Primary Peritoneal Cavity Cancer
  • Drug: mitomycin C
    Given by HIPEC
    Other Names:
    • MITC
    • MITO
    • MITO-C
    • Mitocin-C
    • MTC
  • 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
  • Experimental: Arm I (mitomycin C)
    Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.
    Interventions:
    • Drug: mitomycin C
    • Procedure: therapeutic conventional surgery
    • Other: quality-of-life assessment
    • Drug: hyperthermic intraperitoneal chemotherapy
  • Experimental: Arm II (oxaliplatin)
    Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.
    Interventions:
    • Drug: oxaliplatin
    • Procedure: therapeutic conventional surgery
    • Other: quality-of-life assessment
    • Drug: hyperthermic intraperitoneal chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
116
Not Provided
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT01580410
CCCWFU 59109, NCI-2009-00947
No
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Principal Investigator: Edward Levine Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP