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Trial of Intraperitoneal (IP) Oxaliplatin in Combination With Intravenous FOLFIRI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02833753
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : October 8, 2020
Information provided by (Responsible Party):
Bradley Switzer, University of Massachusetts, Worcester

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Appendix Cancer Peritoneal Carcinomatosis Drug: Oxaliplatin Phase 1

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.

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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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arm Intervention/treatment
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.

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 Level 4: Oxaliplatin 55 mg/m2 IP every 2 weeks on day #1 of chemotherapy (due to DLTs found)

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02833753

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Contact: Cara Gregoire, RN, BSN, MHA 774-4554458
Contact: Giles Whalen, MD 508-856-3216

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United States, Massachusetts
UMass Memorial Medical Center - University Campus Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Bradley Switzer    508-856-3216   
Sponsors and Collaborators
University of Massachusetts, Worcester
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Principal Investigator: Bradley Switzer, MD University of Massachusetts, Worcester
Additional Information:

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Responsible Party: Bradley Switzer, Assistant Professor of Medicine, University of Massachusetts, Worcester Identifier: NCT02833753    
Other Study ID Numbers: H00008477
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Peritoneal Neoplasms
Appendiceal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Abdominal Neoplasms
Peritoneal Diseases
Cecal Neoplasms
Cecal Diseases
Antineoplastic Agents