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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 : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Bradley Switzer, University of Massachusetts, Worcester

Tracking Information
First Submitted Date  ICMJE July 12, 2016
First Posted Date  ICMJE July 14, 2016
Last Update Posted Date August 27, 2019
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02833753 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Intraperitoneal (IP) Oxaliplatin in Combination With Intravenous FOLFIRI
Official Title  ICMJE Phase I Trial of Intraperitoneal Oxaliplatin in Combination With Intravenous FOLFIRI (5-fluorouracil, Leucovorin and Irinotecan) for Peritoneal Carcinomatosis From Colorectal and Appendiceal Cancer
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 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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.

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Appendix Cancer
  • Peritoneal Carcinomatosis
Intervention  ICMJE Drug: Oxaliplatin

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

Study Arms  ICMJE 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 with receive dose level 3.

Intervention: Drug: Oxaliplatin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 13, 2016)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Adquate laboatory 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cara Gregoire, RN, BSN, MHA 774-4554458 Cara.Gregoire@umassmed.edu
Contact: Giles Whalen, MD 508-856-3216 Giles.Whalen@umassmemorial.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02833753
Other Study ID Numbers  ICMJE H00008477
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bradley Switzer, University of Massachusetts, Worcester
Study Sponsor  ICMJE University of Massachusetts, Worcester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bradley Switzer, MD University of Massachusetts, Worcester
PRS Account University of Massachusetts, Worcester
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP