Status:
COMPLETED
Trial of Intraperitoneal (IP) Oxaliplatin in Combination With Intravenous FOLFIRI
Lead Sponsor:
University of Massachusetts, Worcester
Conditions:
Colorectal Cancer
Appendix Cancer
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
There are two common combinations of chemotherapy drugs used to treat cancer of the colon, rectum, or appendix that has spread to the abdomen. One uses 5-fluorouracil (also called 5-FU), leucovorin an...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT02833753
Start Date
July 1 2016
End Date
February 1 2022
Last Update
May 31 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, United States, 01655