Phase 2
Completed N=109
APRiCOT-P: Study of Apricoxib With Gemcitabine and Erlotinib to Treat Advanced Pancreatic Cancer
Source: ClinicalTrials.gov NCT00709826 ↗Enrolled (actual)
109
Serious AEs
19.3%
Results posted
Nov 2012
Primary outcomePrimary: Progression Free Survival — 3.0; 2.8 Months
Summary
This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib in patients with advanced pancreatic cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
3.0; 2.8 | — |
| SECONDARY Overall Survival |
5.0; 4.8 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of the pancreas that is locally advanced or metastatic.
- Life expectancy greater than or equal to 3 months.
- Patients must have measurable disease by RECIST.
- ECOG PS of 0, 1, or 2.
- Negative serum pregnancy test at the time of first dose for women of childbearing potential.
Exclusion Criteria
- Previous chemotherapy as primary treatment for locally advanced or metastatic pancreatic cancer(stage 3 T3 and T4, and all stage 4).
- RT within 2 weeks or chemotherapy within 3 weeks or noncytotoxic investigational agents within 4 weeks of initiating study treatment.
- Evidence of New York Heart Association class III or greater cardiac disease.
- History of myocardial infarction, stroke, ventricular arrhythmia.
- Symptomatic central nervous system metastases.
- Pregnant or nursing women.
- Hypersensitivity or intolerance to apricoxib, erlotinib, gemcitabine, sulfonamides, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs).
- History of upper gastrointestinal bleeding, ulceration or perforation. History of lower GI bleeding, ulceration, or perforation within 12 months.
- Previous anti-EGFR kinase therapy.
Data sourced from ClinicalTrials.gov (NCT00709826). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.