Combination of Irinotecan, Oxaliplatin and Cetuximab for Locally Advanced or Metastatic Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

INST 0802: Phase II Trial of Combination Irinotecan, Oxaliplatin and Cetuximab for Patients With Locally Advanced or Metastatic Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00871169
• Other study ID #: INST 0802
• Secondary ID: NCI-2011-02731
• Status: Completed
• Phase: Phase 2
• First received: March 26, 2009
• Last updated: January 15, 2016
• Start date: October 2008
• Est. completion date: April 2015

Study information

• Verified date: January 2016
• Source: New Mexico Cancer Care Alliance
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This phase II trial studies the side effects and how well irinotecan hydrochloride, oxaliplatin and cetuximab work in treating patients with unresectable or metastatic pancreatic cancer. Irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving irinotecan hydrochloride together with oxaliplatin and cetuximab may kill more tumor cells.

Description:

The investigators will evaluate the side effects and how well irinotecan hydrochloride, oxaliplatin and cetuximab work in treating patients with unresectable or metastatic pancreatic cancer. Irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving irinotecan hydrochloride together with oxaliplatin and cetuximab may kill more tumor cells.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. All patients, 18 years of age or older, with histology proven pancreatic cancer are eligible.

2. Patients must have a life expectancy of at least 12 weeks.

3. Patients must have a Zubrod performance status of 0-2.

4. Patients must sign an informed consent.

5. Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of >= 1,500 or cells/mm3 and platelet count >= 60,000/mm3 and absence of a regular red blood cell transfusion requirement.

6. Patients should have adequate hepatic function with a total bilirubin <= 4.0 mg/dl, could be <= 10 mg/ml if biliary drainage tube is placed and functional in a newly diagnosed patient, and SGOT or SGPT <= four times the upper limit of normal, and adequate renal function as defined by a serum creatinine <= 1.5 x upper limit of normal.

7. For patients that had been treated with one of the study medications will be allowed as long as the treatment did not contain more than 2 study medications at the same time. For example, irinotecan and capecitabine combination will be allowed but not irinotecan and cetuximab. Similarly, gemcitabine with cetuximab will be allowed but not gemcitabine, oxaliplatin and cetuximab. Treated with irinotecan alone followed by oxaliplatin will be allowed but not when irinotecan was in combination with oxaliplatin.

8. Patients are allowed to have up to 2 prior treatments. The protocol will also include chemotherapy naïve patients.

Exclusion Criteria:

1. Patients with symptomatic brain metastases are excluded from this study.

2. Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.

3. Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.

4. Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.

5. Known hypersensitivity reaction to any of the study medications.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Irinotecan, oxaliplatin, and cetuximab
Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes). The treatment interval (one cycle) is every 14 days.

Locations

Country	Name	City	State
United States	Cancer Center at Presbyterian Hospital	Albuquerque	New Mexico
United States	Hematology Oncology Associates	Albuquerque	New Mexico
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	University of New Mexico Cancer Center @ Lovelace Medical Center	Albuquerque	New Mexico
United States	Memorial Medical Center- Cancer Center	Las Cruces	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
New Mexico Cancer Care Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR)	Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). ORR is the sum of the percentages of patients achieving complete and partial responses	2 years	No
Secondary	Toxicity	All toxicities (adverse events) are defined by NCI CTCAE criteria (version 3.0)	2 years	Yes

External Links

•   New Mexico Cancer Care Alliance
•   University of New Mexico Cancer Center