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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Erlotinib
Gemcitabine
Oxaliplatin
Sponsored by
Soonchunhyang University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring advanced unresectable or metastatic Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Soonchunhyang University Bucheon Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tarceva, Gemcitabine, Oxaliplatin

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Overall survival

Full Information

First Posted
January 2, 2012
Last Updated
April 2, 2014
Sponsor
Soonchunhyang University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01505413
Brief Title
Phase 2 Study of Erlotinib, Gemcitabine and Oxaliplatin Combination Chemotherapy to Advanced Pancreatic Cancer
Acronym
GEMOX-T
Official Title
Phase 2 Study of GEMOX-T in Previously Untreated Patients With Advanced Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soonchunhyang University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
advanced unresectable or metastatic Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tarceva, Gemcitabine, Oxaliplatin
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
tarceva
Intervention Description
Erlotinib 100 mg po qd daily
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
gemza, gemcibine
Intervention Description
Gemcitabine 1000 mg/m² with 150mL of normal saline intravenously infusion over 100min on Day 1
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
oxalitin
Intervention Description
Oxaliplatin 100 mg/m2 with 500mL of 5DW intravenously a 2-hour infusion on D2
Primary Outcome Measure Information:
Title
Response rate
Description
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.
Time Frame
24 months (01/2011 and end of study 01/2013)
Secondary Outcome Measure Information:
Title
disease control rate(SD,PR,CR)
Description
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.
Time Frame
24 months (01/2011 and end of study 01/2013)
Title
Overall survival
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age over 18 years ECOG performance status of ≤2 Histologically confirmed adenocarcinoma of the pancreas The disease is Locally advanced deemed by the surgeon to be unresectable, or metastatic disease. Prior chemotherapy is not permitted, except for fluorouracil given concurrently as a radiosensitizer. 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) Pain should be controlled for at least two weeks without an increase in the narcotic consumption. Biliary obstruction should be controlled for at least two weeks evident by stable or improving liver function tests especially total bilirubin. Patient has signed a Patient Informed Consent Form. For all females of childbearing potential, a negative pregnancy test must be obtained within 72 hours before starting therapy. Is able to take medications orally 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: Tumor type other than adenocarcinoma 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) Uncontrolled Nausea and Vomiting Diagnosis of other malignancy in the last 5 years excluding non-melanoma skin cancer and in -situ cervical cancer. Subjects unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for follow- up visits and unlikelihood of completing the study. Any known history of hypersensitivity to the study drugs. Pregnant or lactating women. Symptomatic peripheral sensory neuropathy (NCI CTCAE v3.0 ≥ grade 2) Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu Taek Lee, Dr
Organizational Affiliation
Soonchunhyang University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hee Sook Park, Dr
Organizational Affiliation
Soonchunhyang University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dae Sik Hong, Dr
Organizational Affiliation
Soonchunhyang University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Soonchunhyang University Bucheon Hospital
City
Bucheon
State/Province
Gyeonggi
ZIP/Postal Code
420-767
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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