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| 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. |
| 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
|
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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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Joyce Fenstermaker, RN | 336-713-3155 |
| 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 | |
| Principal Investigator: | John H Stewart IV | Wake Forest University |
More Information
| 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 |
|
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 |