Overview

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