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
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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 |
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 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 |
Arm | Intervention/treatment |
---|---|
Experimental: Arm I (mitomycin C)
Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.
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Drug: mitomycin C
Given by HIPEC
Other Names:
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:
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
|
- 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.
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01580410
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 |
Principal Investigator: | Edward Levine | Wake Forest University Health Sciences |
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 Key Record Dates |
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 |