A Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Patients With Advanced Pancreatic Cancer

• Status: Suspended
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and efficacy of an investigational study drug DN-101 (calcitriol) when given in combination with gemcitabine ± erlotinib in the treatment of pancreatic cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novacea
• Collaborator: Schering-Plough
• Treatments: Calcitriol; Erlotinib Hydrochloride; Gemcitabine

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of locally advanced and unresectable, or metastatic pancreatic cancer

• Performance status 0, 1,or 2

• Adequate bone marrow, renal and hepatic function

Exclusion Criteria:

• Prior chemotherapy or radiation therapy for pancreatic cancer

• Prior treatment for other cancers in last 6 months

• Cancer of the brain or spine

• Active uncontrolled infection

• Hypercalcemia