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

Phase 2
18 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

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

Each two weeks is a cycle. If at end of 12 cycles response continues, will administer
Gemcitabine and erlotinib until progression.

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

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

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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome 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.

Outcome Time Frame:

24 months (01/2011 and end of study 01/2013)

Safety Issue:


Principal Investigator

Kyu Taek Lee, Dr

Investigator Role:

Study Director

Investigator Affiliation:

Soonchunhyang university Cheonan Hospital


Korea: Institutional Review Board

Study ID:




Start Date:

January 2011

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • advanced unresectable or metastatic Pancreatic Cancer
  • Pancreatic Neoplasms