Surgery and Oxaliplatin or Mitomycin C in Treating Patients With Tumors of the Appendix
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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 | Intervention | 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 |
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 HIPEC With Oxaliplatin or Mitomycin C in Patients With Appendiceal Tumors |
- 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.
- 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 ]
Estimated Enrollment: | 116 |
Study Start Date: | May 2009 |
Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Arm I (mitomycin C)
Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.
|
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
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
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 =< 1.5 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
United States, North Carolina | |
Wake Forest University Health Sciences | Recruiting |
Winston-Salem, North Carolina, United States, 27157 | |
Contact: John H. Stewart 336-716-9127 jhstewar@wfubmc.edu | |
Principal Investigator: John H. Stewart | |
United States, Pennsylvania | |
UPMC Hillman Cancer Center | 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: Keith F. Fournier 713-792-8826 kffourni@mdanderson.org | |
Principal Investigator: Keith F. Fournier |
Principal Investigator: | Edward Levine | Comprehensive Cancer Center of Wake Forest University |
No publications provided
Responsible Party: | Comprehensive Cancer Center of Wake Forest University |
ClinicalTrials.gov Identifier: | NCT01580410 History of Changes |
Obsolete Identifiers: | NCT00904267 |
Other Study ID Numbers: | CCCWFU 59109, NCI-2009-00947 |
Study First Received: | April 17, 2012 |
Last Updated: | June 7, 2012 |
Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
Appendiceal Neoplasms Carcinoma Peritoneal Neoplasms Colonic Neoplasms Cecal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Cecal Diseases Intestinal Diseases Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Abdominal Neoplasms Peritoneal Diseases Colorectal Neoplasms Colonic Diseases Mitomycins Mitomycin Oxaliplatin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on October 17, 2012