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

This study is currently recruiting participants.
Verified July 2017 by Bradley Switzer, University of Massachusetts, Worcester
Sponsor:
ClinicalTrials.gov Identifier:
NCT02833753
First Posted: July 14, 2016
Last Update Posted: July 24, 2017
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.
Information provided by (Responsible Party):
Bradley Switzer, University of Massachusetts, Worcester
  Purpose
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 Intervention Phase
Colorectal Cancer Appendix Cancer Peritoneal Carcinomatosis Drug: Oxaliplatin Phase 1

Study Type: Interventional
Study Design: 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 and is near completing. Group #3 is at 85mg/m2 of IP oxaliplatin and we haven't started enrolling yet.

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

Resource links provided by NLM:


Further study details as provided by Bradley Switzer, University of Massachusetts, Worcester:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 16
Study Start Date: July 2016
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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


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.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • The patient 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
  • Patients must be willing to return for follow-up
  • The patient must consent to participate in the trial and must have signed an approved informed consent form conforming to institutional policy
  • The patient 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)
  • The patient must have active measurable disease by either abdominal computerized axial tomography (CT)/ Magnetic resonance imaging (MRI) or laparoscopy.

At the time of enrollment, the patient must have: (within 14 days of enrollment)

  • Absolute neutrophil count (ANC) > 1200/mm3 and platelet count > 140,000/mm3
  • An international normalized ratio (INR) ≤ 1.5 (patients who are therapeutically anticoagulated for non-related medical conditions such as atrial fibrillation and whose anti- thrombotic treatment can be withheld for operation will be eligible)
  • Adequate hepatic function must be met as evidenced by total serum bilirubin ≤ 1.5 mg/dl (patients with total bilirubin >1.5 mg/dL eligible only with Gilbert's syndrome); alkaline phosphatase < 2.5 times the upper limit of normal; and, aspartate aminotransferase (AST) less than 1.5 times upper limit of normal [alkaline phosphatase and AST cannot both exceed the upper limit of normal]
  • Serum renal functional parameters, blood urea nitrogen (BUN) and creatinine are within normal limits (estimated glomerular filtration rate (eGFR) >50)
  • Prior to enrollment the patient must have had a complete history and physical examination, electrocardiogram, within three months of enrollment
  • 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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02833753


Contacts
Contact: Bradley Switzer, MD 774-442-3716 bradley.switzer@umassmemorial.org
Contact: Laura Lambert, MD 508-334-5274 laura.lambert@umassmemorial.org

Locations
United States, Massachusetts
UMass Memorial Medical Center - University Campus Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Bradley Switzer    774-442-3716    bradley.switzer@umassmemorial.org   
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Bradley Switzer, MD University of Massachusetts, Worcester
  More Information

Additional Information:
Publications:

Responsible Party: Bradley Switzer, Assistant Professor of Medicine, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT02833753     History of Changes
Other Study ID Numbers: H00008477
First Submitted: July 12, 2016
First Posted: July 14, 2016
Last Update Posted: July 24, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Colorectal Neoplasms
Carcinoma
Appendiceal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cecal Neoplasms
Cecal Diseases
Oxaliplatin
Antineoplastic Agents