Trial of Intraperitoneal (IP) Oxaliplatin in Combination With Intravenous FOLFIRI
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|ClinicalTrials.gov Identifier: NCT02833753|
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : October 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Appendix Cancer Peritoneal Carcinomatosis||Drug: Oxaliplatin||Phase 1|
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 and oxaliplatin, and is called FOLFOX. The other uses 5-FU, leucovorin, and irinotecan, and is called FOLFIRI. The Food and Drug Administration (FDA) has approved each of these combinations as treatment for colon or rectal cancer. Each is given through the veins.
FOLFOX and FOLFIRI do not work well for tumors growing in the abdominal cavity. The investigators are trying to determine if giving chemotherapy called oxaliplatin directly into the abdominal cavity will have a greater effect on the cancer.
The FDA has approved oxaliplatin to be given to people through their veins to treat advanced colorectal cancer. Giving oxaliplatin directly into the abdomen in this study is experimental and is not approved by the FDA. This study will give the standard chemotherapy FOLFIRI through the veins and oxaliplatin directly into the abdomen. This is the first time intraperitoneal oxaliplatin is being given in combination with FOLFIRI.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||
There are three cohorts of patients:
Group #1 is at 25mg/m2 of IP oxaliplatin and has been completed. Group #2 is at 55mg/m2 of IP oxaliplatin is completed. Group #3 is at 85mg/m2 of IP oxaliplatin is currently enrolling. If DLTs found additional 3 subjects will be dosed at the lower dose level cohort.
2 DLTs were found in the 85 mg/m2 cohort therefore 3 additional subjects (Group # 4) will be enrolled to the 55 mg/m2 cohort.
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||September 2021|
Experimental: Dose Escalation
Single arm dose finding for intraperitoneal Oxaliplatin. All patients will receive experimental treatment.
The first cohort of 3 patients will receive dose level 1. The second cohort of 3 patients will receive dose level 2. The Third cohort of 3 patients will receive dose level 3. The fourth cohort of 3 patients will receive dose level 2.
Intraperitoneal oxaliplatin will be given along with standard chemotherapy FOLFIRI.
Level 1: Oxaliplatin 25mg/m2 IP every 2 weeks on day #1 of chemotherapy . Level 2: Oxaliplatin 55mg/m2 IP every 2 weeks on day #1 of chemotherapy Level 3: Oxaliplatin 85mg/m2 IP every 2 weeks on day #1 of chemotherapy Level 4: Oxaliplatin 55 mg/m2 IP every 2 weeks on day #1 of chemotherapy (due to DLTs found)
- 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 [ Time Frame: 8 weeks ]
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): NCT02833753
|Contact: Cara Gregoire, RN, BSN, MHA||774-4554458||Cara.Gregoire@umassmed.edu|
|Contact: Giles Whalen, MD||508-856-3216||Giles.Whalen@umassmemorial.org|
|United States, Massachusetts|
|UMass Memorial Medical Center - University Campus||Recruiting|
|Worcester, Massachusetts, United States, 01655|
|Contact: Bradley Switzer 508-856-3216 email@example.com|
|Principal Investigator:||Bradley Switzer, MD||University of Massachusetts, Worcester|