Status:
COMPLETED
Phase 2 Study of Erlotinib, Gemcitabine and Oxaliplatin Combination Chemotherapy to Advanced Pancreatic Cancer
Lead Sponsor:
Soonchunhyang University Hospital
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. Er...
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 1...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01505413
Start Date
January 1 2011
End Date
March 1 2014
Last Update
April 3 2014
Active Locations (1)
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1
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, South Korea, 420-767