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

Sponsor
Soonchunhyang University Hospital
Study ID
NCT01505413
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    Erlotinib 100 mg po qd daily
  • Gemcitabine — DRUG
    Gemcitabine 1000 mg/m² with 150mL of normal saline intravenously infusion over 100min on Day 1
  • Oxaliplatin — DRUG
    Oxaliplatin 100 mg/m2 with 500mL of 5DW intravenously a 2-hour infusion on D2

Study Details

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.

Key Dates

First listed
Jan 6, 2012
Start date
Jan 31, 2011
Status verified
Apr 2014
Primary completion
Dec 31, 2013
Completion
Mar 31, 2014

Study Design

Enrollment
33 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Response rate [ Time Frame: 24 months (01/2011 and end of study 01/2013) ]

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