Gemcitabine Plus Erlotinib in RASH-positive Patients With Metastatic Pancreatic Cancer

Sponsor
Ludwig-Maximilians - University of Munich
Study ID
NCT01729481
Phase
PHASE2
Status
Unknown

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    1000 mg/m² iv weekly
  • Erlotinib — DRUG
    100mg, once per day
  • Oxaliplatin — DRUG
    85mg/m², q2weeks
  • Folinic Acid — DRUG
    400 mg/m², q2weeks
  • Irinotecan — DRUG
    180 mg/m², q2weeks
  • 5-FU — DRUG
    400 mg/m² Day 1; 2400 mg/m² 46 hour invusion, q2weeks

Study Details

In the current study it is examined whether patients with good risk factors (age \<75 years, total serum bilirubin \< 1,5xULN, no history of cardiovascular diseases) treated with gemcitabine and erlotinib who developed skin rash of any grade during the first 4 weeks of treatment have a comparable outcome as patients who receive FOLFIRINOX.

Key Dates

Start date
Jul 31, 2012
Status verified
Jul 2017
Primary completion
Jul 31, 2015
Completion
Dec 31, 2017

Study Design

Enrollment
150 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: RASH positive
    Run-In-Phase during 4 weeks: Gemcitabine 1000 mg/m², weekly Erlotinib 100 mg, weekly Thereafter Treatment in patients with RASH-positve outcome after 4 weeks.
  • Active Comparator: RASH-negative
    Run-In-Phase during 4 weeks: Gemcitabine 1000 mg/m², weekly Erlotinib 100 mg, weekly RASH-negative patients quit treatment with Gemcitabine + Erlotinib and continue treatment with FOLFIRINOX: Oxaliplatin 85mg/m2 Irinotecan 180 mg/m2 Folinic acid 400 mg/m2 5-FU 400 mg/m2 bolus iv 5-FU 2400 mg/m2 46-hours continous infusion

Primary Outcome Measure

1-year Survial rate of "good-risk" patients [ Time Frame: Follow-Up Phase (1.5 years) ]

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