Colorectal Cancer Clinical Trial
Official title:
Phase I Trial of Intraperitoneal Oxaliplatin in Combination With Intravenous FOLFIRI (5-fluorouracil, Leucovorin and Irinotecan) for Peritoneal Carcinomatosis From Colorectal and Appendiceal Cancer
NCT number | NCT02833753 |
Other study ID # | H00008477 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | February 2022 |
Verified date | May 2022 |
Source | University of Massachusetts, Worcester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a Phase I dose escalation study to determine how much chemotherapy can be safely administered into the abdomen while experiencing the fewest possible side effects.
Status | Completed |
Enrollment | 14 |
Est. completion date | February 2022 |
Est. primary completion date | February 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Must be 18 years of age or older and capable of providing informed consent indicating awareness of the investigational nature of this trial, in keeping with institutional policy - Must consent to participate in the trial and have signed an approved informed consent form conforming to institutional policy - Must have histopathologically or cytologically confirmed colon, rectal or appendiceal adenocarcinoma with synchronous or metachronous peritoneal dissemination of disease.(Stage IV peritoneal based disease only) - Must have active measurable disease by either abdominal computerized axial tomography (CT)/ Magnetic resonance imaging (MRI) or laparoscopy. Adequate laboratory values - Absolute neutrophil count (ANC) > 1200/10*3/uL - Platelet count > 140,000/10*3/uL - Total serum bilirubin = 1.5 mg/dl (patients with total bilirubin >1.5 mg/dL are eligible only with Gilbert's syndrome) - Alkaline phosphatase < 2.5 times the upper limit of normal (ULN) (alkaline phosphatase and AST cannot both exceed the ULN) - Aspartate aminotransferase (AST) < 1.5 times the ULN (alkaline phosphatase and AST cannot both exceed the ULN) - Serum renal function parameters (BUN and creatinine) are within normal limits (eGFR) >50) - Satisfactory cardiopulmonary function (as determined by Physician) - Patients can have received prior systemic chemotherapy, radiation or surgery - Patients must be able to undergo placement of an intraperitoneal (IP) catheter and a Port-A Cath, if not already present - Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less - Women of reproductive age and men who are sexually active must be willing to practice effective contraception - Patients will be allowed to have secondary malignancies as long as they do not require active concomitant treatment |
Country | Name | City | State |
---|---|---|---|
United States | UMass Memorial Medical Center - University Campus | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
University of Massachusetts, Worcester |
United States,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Define the maximum tolerated dose (MTD) of intraperitoneal (IP) oxaliplatin given with systemic FOLFIRI in patients with peritoneal carcinomatosis (PC) of colorectal or appendiceal origin | 8 weeks |
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