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

Primary Purpose

Colorectal Cancer, Appendix Cancer, Peritoneal Carcinomatosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Oxaliplatin

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UMass Memorial Medical Center - University Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose Escalation

Arm Description

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.

Outcomes

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02833753

First Posted

July 12, 2016

Last Updated

May 27, 2022

Sponsor

University of Massachusetts, Worcester

1. Study Identification

Unique Protocol Identification Number

NCT02833753

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

July 2016 (undefined)

Primary Completion Date

February 2022 (Actual)

Study Completion Date

February 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Massachusetts, Worcester

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Appendix Cancer, Peritoneal Carcinomatosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

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)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose Escalation

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Description

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 Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bradley Switzer, MD

Organizational Affiliation

University of Massachusetts, Worcester

Official's Role

Principal Investigator

Facility Information:

Facility Name

UMass Memorial Medical Center - University Campus

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01655

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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