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NCT00536770 Clinical Trial

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

Pancreatic Cancer Clinical Trial

Official title:
A Randomized Phase 2 Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Subjects With Advanced Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT00536770
Other study ID # 011-017
Secondary ID
Status Suspended
Phase Phase 2
First received September 26, 2007
Last updated November 2, 2007
Start date September 2007

Study information
Verified date November 2007
Source Novacea
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Suspended
Enrollment 132
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• placebo + gemcitabine + erlotinib

• Placebo + gemcitabine

• calcitriol + gemcitabine

• calcitriol + gemcitabine + erlotinib

Locations
Country Name City State
United States Novacea Investigational Site Nashville Tennessee

Sponsors (2)
Lead Sponsor Collaborator
Novacea Schering-Plough

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival rate at 6 months
Secondary Objective response rate
Secondary Duration of progression free survival
Secondary Duration of overall survival
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