Phase 2 Study Of Erlotinib, Gemcitabine And Oxaliplatin Combination Chemotherapy To Advanced Pancreatic Cancer

Study Overview

Phase 2 Study of Erlotinib, Gemcitabine and Oxaliplatin Combination Chemotherapy to Advanced Pancreatic Cancer

Erlotinib is an orally available, reversible tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR). Association of chemoresistance with the activity of certain tyrosine kinases (e.g. ErbB-1 and Src) has been described for pancreatic cancer and makes a strong case for combining gemcitabine with tyrosine kinase inhibitors. In a phase III trial, the addition of erlotinib to gemcitabine improved survival compared with gemcitabine alone in advanced pancreatic cancer (MJ Moor et al). Also, gemcitabine in combination with oxaliplatin is superior to gemcitabine alone in terms of progression free survival and response rate in one phase III trial (Louvet et al). Taken together, combining erlotinib with gemcitabine and oxaliplatin may further improve the overall survival and clinical benefit of advanced pancreatic cancer.

Open, uncontrolled, multicenter, phase II study This study will enroll previous chemo-naïve patients with locally advanced unresectable or metastatic pancreatic cancer. Study regimen: * Erlotinib 100 mg po qd daily AND * Gemcitabine 1000 mg/m² with 150mL of normal saline intravenously infusion over 100min on Day 1 * Oxaliplatin 100 mg/m2 with 500mL of 5DW intravenously a 2-hour infusion on D2 Every 2 weeks Each two weeks is a cycle. If at end of 12 cycles response continues, will administer Gemcitabine and erlotinib until progression.

Pancreatic Cancer

DRUG: Erlotinib
DRUG: Gemcitabine
DRUG: Oxaliplatin

Yun-11349

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-01-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-04-02
First Submitted that Met QC Criteria 2012-01-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-04-03
First Posted (ESTIMATED) 2012-01-06	Results First Posted N/A	Last Verified 2014-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Tarceva, Gemcitabine, Oxaliplatin * Erlotinib 100 mg po qd daily AND * Gemcitabine 1000 mg/m² with 150mL of normal saline intravenously infusion over 100min on Day 1 * Oxaliplatin 100 mg/m2 with 500mL of 5DW intravenously a 2-hour infusion on D2 Every 2 weeks Each two weeks is a cycle. I	DRUG: Erlotinib Erlotinib 100 mg po qd daily DRUG: Gemcitabine Gemcitabine 1000 mg/m² with 150mL of normal saline intravenously infusion over 100min on Day 1 DRUG: Oxaliplatin Oxaliplatin 100 mg/m2 with 500mL of 5DW intravenously a 2-hour infusion on D2

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Tarceva, Gemcitabine, Oxaliplatin

* Erlotinib 100 mg po qd daily AND * Gemcitabine 1000 mg/m² with 150mL of normal saline intravenously infusion over 100min on Day 1 * Oxaliplatin 100 mg/m2 with 500mL of 5DW intravenously a 2-hour infusion on D2 Every 2 weeks Each two weeks is a cycle. I

DRUG: Erlotinib

Erlotinib 100 mg po qd daily

DRUG: Gemcitabine

Gemcitabine 1000 mg/m² with 150mL of normal saline intravenously infusion over 100min on Day 1

DRUG: Oxaliplatin

Oxaliplatin 100 mg/m2 with 500mL of 5DW intravenously a 2-hour infusion on D2

Primary Outcome Measures	Measure Description	Time Frame
Response rate	Responses are assessed every 2 cycles according to RECIST; the imaging tests are performed in a week preceding the corresponding cycles, and can also be repeated at any other time if clinically indicated, for example, to confirm disease progression. At any time, patients with progressive disease are withdrawn.	24 months (01/2011 and end of study 01/2013)

Secondary Outcome Measures	Measure Description	Time Frame
disease control rate(SD,PR,CR)	Responses are assessed every 2 cycles according to RECIST; the imaging tests are performed in a week preceding the corresponding cycles, and can also be repeated at any other time if clinically indicated, for example, to confirm disease progression. At any time, patients with progressive disease are withdrawn.	24 months (01/2011 and end of study 01/2013)
Overall survival		1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Number of absolute neutrophil counts (ANC) > 1.5 x 109/L
Number of thrombocytes > 100 x 109/L
Total bilirubin < 1.5 x upper limit of normal (although patients with a Total bilirubin count between 1.5 and 3 x upper limit of normal in whom a decrease is anticipated, ex. Biliary stent insertion)ALAT, ASAT < 3 x upper limit of normal (in case of liver metastasis, 5 x upper limit of normal)
Alkaline phosphatase < 3 x upper limit of normal (in case of liver metastasis, 5 x upper limit of normal) 7. Pain should be controlled for at least two weeks without an increase in the narcotic consumption. 8. Biliary obstruction should be controlled for at least two weeks evident by stable or improving liver function tests especially total bilirubin. 9. Patient has signed a Patient Informed Consent Form. 10. For all females of childbearing potential, a negative pregnancy test must be obtained within 72 hours before starting therapy. 11. Is able to take medications orally 12. A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in spiral CT or multidetector CT (MD CT) or 20 mm or longer in conventional CT (it should be used by a consistent method during the study period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Kyu Taek Lee, Dr, Soonchunhyang University Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Clinical Trial Record