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

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ClinicalTrials.gov Identifier: NCT01580410
Recruitment Status : Completed
First Posted : April 19, 2012
Results First Posted : March 21, 2018
Last Update Posted : March 21, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

April 17, 2012
April 19, 2012
December 21, 2017
March 21, 2018
March 21, 2018
May 2009
October 2015   (Final data collection date for primary outcome measure)
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.
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 ]
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.
Complete list of historical versions of study NCT01580410 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • 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.
  • 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 ]
  • 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 ]
  • Quality of life as assessed by FACT-G [ Time Frame: Up to 3 years ]
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: None (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.
 
Completed
136
116
November 2016
October 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01580410
CCCWFU 59109
NCI-2009-00947 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Wake Forest University Health Sciences
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Principal Investigator: Edward Levine Wake Forest University Health Sciences
Wake Forest University Health Sciences
December 2017

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