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

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Brief Title

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

Official Title

Phase 2 Study of GEMOX-T in Previously Untreated Patients With Advanced Pancreatic Cancer

Brief Summary

      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.
    

Detailed Description

      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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Response rate

Secondary Outcome

 disease control rate(SD,PR,CR)

Condition

Pancreatic Cancer

Intervention

Erlotinib

Study Arms / Comparison Groups

 Tarceva, Gemcitabine, Oxaliplatin
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

33

Start Date

January 2011

Completion Date

March 2014

Primary Completion Date

December 2013

Eligibility Criteria

        Inclusion Criteria:

          1. Age over 18 years

          2. ECOG performance status of ≤2

          3. Histologically confirmed adenocarcinoma of the pancreas

          4. The disease is Locally advanced deemed by the surgeon to be unresectable, or
             metastatic disease.

          5. Prior chemotherapy is not permitted, except for fluorouracil given concurrently as a
             radiosensitizer.

          6. Patients must have normal organ function evidenced by

               -  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)

        Exclusion Criteria:

          1. Tumor type other than adenocarcinoma

          2. Evidence of uncontrolled CNS disease (patients with controlled CNS disease for 4 weeks
             using the same imaging method and for whom are off steroid will be eligible)

          3. Uncontrolled Nausea and Vomiting

          4. Diagnosis of other malignancy in the last 5 years excluding non-melanoma skin cancer
             and in -situ cervical cancer.

          5. Subjects unlikely to comply with protocol, e.g. uncooperative attitude, inability to
             return for follow- up visits and unlikelihood of completing the study.

          6. Any known history of hypersensitivity to the study drugs.

          7. Pregnant or lactating women.

          8. Symptomatic peripheral sensory neuropathy (NCI CTCAE v3.0 ≥ grade 2)

          9. Other serious illness or medical condition, notably heart or lung failure, active
             uncontrolled infection

         10. Prior radiotherapy was administered to target lesions selected for this study, or
             radiotherapy to the non-target lesions has been completed within 4 weeks before being
             included in the study.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Kyu Taek Lee, Dr, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT01505413

Organization ID

Yun-11349


Responsible Party

Principal Investigator

Study Sponsor

Soonchunhyang University Hospital


Study Sponsor

Kyu Taek Lee, Dr, Study Director, Soonchunhyang University Cheonan Hospital


Verification Date

April 2014