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Phase 2 Study of Erlotinib, Gemcitabine and Oxaliplatin Combination Chemotherapy to Advanced Pancreatic Cancer (GEMOX-T)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jina Yun, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier:
NCT01505413
First received: January 2, 2012
Last updated: February 20, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
 Drug: Erlotinib
Drug: Gemcitabine
Drug: Oxaliplatin
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of GEMOX-T in Previously Untreated Patients With Advanced Pancreatic Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Soonchunhyang University Hospital:

Primary Outcome Measures:
  • Response rate [ Time Frame: 24 months (01/2011 and end of study 01/2013) ] [ Designated as safety issue: Yes ]
    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 At any time, patients with progressive disease are withdrawn.


Secondary Outcome Measures:
  • disease control rate(SD,PR,CR) [ Time Frame: 24 months (01/2011 and end of study 01/2013) ] [ Designated as safety issue: No ]
    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.

  • Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: January 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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. If at end of 12 cycles response continues, will administer Gemcitabine and erlotinib until progression.

 Drug: Erlotinib
Erlotinib 100 mg po qd daily
Other Name: tarceva
Drug: Gemcitabine
Gemcitabine 1000 mg/m² with 150mL of normal saline intravenously infusion over 100min on Day 1
Other Names:
  • gemza
  • gemcibine
Drug: Oxaliplatin
Oxaliplatin 100 mg/m2 with 500mL of 5DW intravenously a 2-hour infusion on D2
Other Name: oxalitin

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505413

Locations
Korea, Republic of
Soonchunhyang University Bucheon Hospital
Bucheon, Gyeonggi, Korea, Republic of, 420-767
Sponsors and Collaborators
Soonchunhyang University Hospital
Investigators
Study Director: Kyu Taek Lee, Dr Soonchunhyang university Cheonan Hospital
Study Director: Hee Sook Park, Dr Soonchunhyang University Hospital
Study Director: Dae Sik Hong, Dr Soonchunhyang University Bucheon Hospital
  More Information

No publications provided

Responsible Party: Jina Yun, Division of Oncology-Hematology Department of Internal medicine, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT01505413     History of Changes
Other Study ID Numbers: Yun-11349
Study First Received: January 2, 2012
Last Updated: February 20, 2013
Health Authority: Korea: Institutional Review Board
Korea: Food and Drug Administration

Keywords provided by Soonchunhyang University Hospital:
advanced unresectable 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
Gemcitabine
Erlotinib
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013