Combination of Irinotecan, Oxaliplatin and Cetuximab for Locally Advanced or Metastatic Pancreatic Cancer
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Purpose
The purpose of this Phase II study is to determine how safe and effective treatment using the combination of chemotherapy drugs irinotecan, oxaliplatin and cetuximab is in controlling pancreatic cancer. Cetuximab (ERBITUX TM) has been approved by the FDA for the treatment of cancer of the head and neck, colon, or rectum. Oxaliplatin and irinotecan have both been FDA-approved for the treatment of colorectal cancer. However, this combination of drugs is considered experimental because this combination of the 3 drugs, oxaliplatin, irinotecan, or cetuximab, is not approved by the Food and Drug Administration (FDA) for the treatment of any type of cancer. However, use of this combination of drugs at the UNM CC has shown a significant effect on reducing tumor size in patients with locally advanced or metastatic pancreatic cancer.
| 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 |
- To determine the efficacy of combination irinotecan, oxaliplatin and cetuximab for patients with diagnosis of pancreatic cancers. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- To determine the toxicity profile of this combination chemotherapy regimen in patients with appropriate histologic diagnosis. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 65 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Treatment with a combination of irinotecan, capecitabine and cetuximab
|
Drug: irinotecan, oxaliplatin and cetuximab
The following will be the starting dose for the study: Irinotecan - 90 mg/m2 intravenously every two weeks. Oxaliplatin - 60 mg/m2 intravenously every two weeks. Cetuximab - 250 mg/m2 intravenously every two weeks. The treatment interval (one cycle) is every 14 days. Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All patients, 18 years of age or older, with histology proven pancreatic cancer are eligible.
- Patients must have a life expectancy of at least 12 weeks.
- Patients must have a Zubrod performance status of 0-2.
- Patients must sign an informed consent.
- 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.
- 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.
- 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.
- Patients are allowed to have up to 2 prior treatments. The protocol will also include chemotherapy naïve patients.
Exclusion Criteria:
- Patients with symptomatic brain metastases are excluded from this study.
- Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
- Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
- Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
- Known hypersensitivity reaction to any of the study medications.
Contacts and Locations| Contact: Valerie Parks, BSN | 505-925-0390 | vparks@salud.unm.edu |
| United States, New Mexico | |
| University of New Mexico Cancer Center | Recruiting |
| Albuquerque, New Mexico, United States, 87131-0001 | |
| Contact: Valerie Parks, BSN 505-925-0390 vparks@salud.unm.edu | |
| Principal Investigator: Fa-Chyi Lee, M.D. | |
| University of New Mexico Cancer Center @ Lovelace Medical Center | Recruiting |
| Albuquerque, New Mexico, United States, 87102 | |
| Contact: John Pierce, RN 505-925-7488 jpierce@salud.unm.edu | |
| Principal Investigator: Fay-Chyi Lee, MD | |
| Hematology Oncology Associates | Recruiting |
| Albuquerque, New Mexico, United States, 87106 | |
| Contact: Debbie Winklejohn, RN 505-938-5858 debbiew@hoanm.com | |
| Principal Investigator: Malcolm Purdy, MD | |
| Cancer Center at Presbyterian Hospital | Recruiting |
| Albuquerque, New Mexico, United States, 87110 | |
| Contact: Wendy Burman, RN wburman@phs.org | |
| Principal Investigator: Bernard Agbemadzo, MD | |
| Memorial Medical Center- Cancer Center | Completed |
| Las Cruces, New Mexico, United States, 88011 | |
| 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: | March 5, 2013 |
| 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 Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Oxaliplatin Irinotecan Cetuximab |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Phytogenic Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013