NCT01222689

Selumetinib and Erlotinib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

A Phase 2 Study of AZD6244 Plus Erlotinib for the Second-Line Treatment of Advanced Pancreatic Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well giving selumetinib and erlotinib hydrochloride together works in treating patients with locally advanced or metastatic pancreatic cancer that is refractory to chemotherapy. Selumetinib and erlotinib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: l. To assess overall survival (as measured by median survival and proportion of patients alive at 24 weeks) in patients with advanced pancreatic cancer who have received one prior line of systemic therapy when treated with the combination of AZD6244 (selumetinib) and erlotinib (erlotinib hydrochloride). SECONDARY OBJECTIVES: I. Progression-free survival (median progression-free survival \[PFS\] and proportion of patients with PFS at 12 and 24 weeks). II. Cancer antigen (CA)19-9 biomarker response (defined as a 50% decline in serum CA19-9 level from baseline in patients with \> 2 x upper limit of normal \[ULN\] CA19-9 measurement). III. Objective radiographic response by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. IV. Safety and toxicity profile of the combination of AZ6244 and erlotinib. OUTLINE: Patients receive selumetinib orally (PO) once daily (QD) and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2-3 months.

Conditions

• Adenocarcinoma of the Pancreas
• Recurrent Pancreatic Cancer
• Stage III Pancreatic Cancer
• Stage IV Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	erlotinib hydrochloride	Given PO
DRUG	selumetinib	Given PO
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2010-11-01
• Primary completion: 2013-04-01
• Completion: 2014-09-01
• First posted: 2010-10-18
• Last updated: 2020-07-31
• Results posted: 2016-11-07

Locations

2 sites across 1 country: United States