APRiCOT-P: Study of Apricoxib With Gemcitabine and Erlotinib to Treat Advanced Pancreatic Cancer

Tragara Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Metastatic Pancreatic Cancer; Pancreatic Cancer

Treatments: Drug: gemcitabine; Drug: Erlotinib; Drug: placebo; Drug: apricoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00709826

APRiCOT-P (Other Identifier)

TP2001-203

Details and patient eligibility

About

This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib in patients with advanced pancreatic cancer.

Full description

This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib as measured by progression-free survival to test the hypothesis that down regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumors will have a clinical benefit compared with Gemcitabine/Erlotinib only.

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically or cytologically confirmed adenocarcinoma of the pancreas that is locally advanced or metastatic.
2. Life expectancy greater than or equal to 3 months.
3. Patients must have measurable disease by RECIST.
4. ECOG PS of 0, 1, or 2.
5. Negative serum pregnancy test at the time of first dose for women of childbearing potential.

Exclusion criteria

1. Previous chemotherapy as primary treatment for locally advanced or metastatic pancreatic cancer(stage 3 T3 and T4, and all stage 4).
2. RT within 2 weeks or chemotherapy within 3 weeks or noncytotoxic investigational agents within 4 weeks of initiating study treatment.
3. Evidence of New York Heart Association class III or greater cardiac disease.
4. History of myocardial infarction, stroke, ventricular arrhythmia.
5. Symptomatic central nervous system metastases.
6. Pregnant or nursing women.
7. Hypersensitivity or intolerance to apricoxib, erlotinib, gemcitabine, sulfonamides, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs).
8. History of upper gastrointestinal bleeding, ulceration or perforation. History of lower GI bleeding, ulceration, or perforation within 12 months.
9. Previous anti-EGFR kinase therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

109 participants in 2 patient groups, including a placebo group

apricoxib + gemcitabine + erlotinib

Experimental group

Description:

400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib

Treatment:

Drug: apricoxib

Drug: Erlotinib

Drug: gemcitabine

placebo + gemcitabine + erlotinib

Placebo Comparator group

Description:

placebo + 1000mg/m2 gemcitabine + 100mg erlotinib

Treatment:

Drug: placebo

Drug: Erlotinib

Drug: gemcitabine