At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 153 enrolled
Drug / intervention
Erlotinib +1 moredrug
Likely dose
Erlotinib 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Study of Tarceva in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas : Relationship Between Skin Rash and Survival
In Brief
A Phase 2 clinical trial evaluating Erlotinib and Gemcitabine for Pancreatic Cancer. Completed, enrolled 153 participants across 29 sites.
Detailed Summary
This single arm study will evaluate the relationship between the skin toxicity of Tarceva in combination with gemcitabine, and survival, in patients with advanced and/or metastatic pancreatic cancer. All patients will receive gemcitabine 100mg/m2 i.v. weekly; Tarceva will be administered 100mg po per day. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Cancer
CountriesSpain
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2007
Enrollment StartMay 2007
Primary CompletionNov 2010
TodayJul 2026
First PostedApr 18, 2007
Enrollment StartMay 1, 2007
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 19.2 years ago
Interventions
Erlotinibdrug
100 mg, PO, once per day
Gemcitabinedrug
1000 mg/m2, IV, on Days 1, 8 and 15 in 4-week cycles