A Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Patients With Advanced Pancreatic Cancer
Phase 2
Suspended
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT00536770
- Lead Sponsor
- Novacea
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 132
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Placebo + gemcitabine Placebo + gemcitabine B placebo + gemcitabine + erlotinib Placebo + gemcitabine + erlotinib C calcitriol + gemcitabine DN-101 + gemcitabine D calcitriol + gemcitabine + erlotinib DN-101 + gemcitabine + erlotinib
- Primary Outcome Measures
Name Time Method Overall survival rate at 6 months
- Secondary Outcome Measures
Name Time Method Duration of overall survival Objective response rate Duration of progression free survival
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie calcitriol's efficacy in combination with gemcitabine for pancreatic adenocarcinoma?
How does the calcitriol-gemcitabine-erlotinib regimen compare to standard-of-care therapies in advanced pancreatic cancer outcomes?
Which biomarkers correlate with response to calcitriol plus gemcitabine ± erlotinib in VEGF or EGFR pathway contexts?
What are the key adverse events associated with calcitriol combination therapy in NCT00536770 and how were they managed?
Are there alternative vitamin D analogs or EGFR inhibitors with similar therapeutic potential to DN-101 in pancreatic cancer?
Trial Locations
- Locations (1)
Novacea Investigational Site
🇺🇸Nashville, Tennessee, United States
Novacea Investigational Site🇺🇸Nashville, Tennessee, United States