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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00871169
First received: March 26, 2009
Last updated: June 17, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: Irinotecan, oxaliplatin, and cetuximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: INST 0802: Phase II Trial of Combination Irinotecan, Oxaliplatin and Cetuximab for Patients With Locally Advanced or Metastatic Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • Overall response rate (ORR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    All toxicities (adverse events) are defined by NCI CTCAE criteria (version 3.0)


Estimated Enrollment: 65
Study Start Date: October 2008
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Irinotecan, oxaliplatin, and cetuximab
At least 4 cycles will be administered to each patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)
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.

Other Names:
  • Eloxatin
  • ERBITUX

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871169

Locations
United States, New Mexico
Cancer Center at Presbyterian Hospital
Albuquerque, New Mexico, United States, 87110
Hematology Oncology Associates
Albuquerque, New Mexico, United States, 87106
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-0001
University of New Mexico Cancer Center @ Lovelace Medical Center
Albuquerque, New Mexico, United States, 87102
Memorial Medical Center- Cancer Center
Las Cruces, New Mexico, United States, 88011
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
Principal Investigator: Fa-Chyi Lee, M.D. University of New Mexico Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00871169     History of Changes
Other Study ID Numbers: INST 0802, NCI-2011-02731
Study First Received: March 26, 2009
Last Updated: June 17, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by New Mexico Cancer Care Alliance:
Irinotecan
Oxaliplatin
Cetuximab
Advanced or metastatic pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Cetuximab
Irinotecan
Oxaliplatin
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on June 30, 2015