A Study of Erlotinib in Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

A Phase IIIb Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02694536
• Other study ID #: ML19537
• Secondary ID: 2005-004605-29
• Status: Completed
• Phase: Phase 3
• First received: February 24, 2016
• Last updated: February 24, 2016
• Start date: June 2006
• Est. completion date: November 2009

Study information

• Verified date: February 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Not Applicable
• Study type: Interventional

Clinical Trial Summary

This open-label, single-arm, multicenter trial is designed to evaluate the safety of erlotinib in combination with standard of care chemotherapy (gemcitabine) in participants with locally advanced, unresectable, or metastatic pancreatic cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma with locally advanced, unresectable, or metastatic disease

• No prior systemic treatment for metastatic disease

• Adjuvant therapy greater than or equal to (</=) 6 months prior to study entry with no residual toxic effects

• Age >/=18 years

• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3

• Life expectancy >/=12 weeks

• Adequate hematologic, hepatic, and renal function

• Negative pregnancy test within 72 hours of study drug and use of effective contraception among women of childbearing potential

Exclusion Criteria:

• Unstable systemic disease

• Prior systemic human epidermal growth factor receptor 1 (HER1) or epidermal growth factor receptor (EGFR) inhibitors

• Other malignancy within 5 years prior to study entry

• Significant opthalmologic abnormality

• Inability to take oral medication

• Need for IV alimentation

• Prior surgery affecting absorption

• Active peptic ulcer disease

• Nursing mothers

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Erlotinib
Participants will receive erlotinib tablets as 100 milligrams (mg) orally (PO) once daily.
• Gemcitabine
Participants will receive gemcitabine as 1000 milligrams per meter-squared (mg/m^2) via intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Adverse Events (AEs)		Continuously during treatment (up to approximately 12 months)	No
Secondary	European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score		At Baseline, every 4 weeks during treatment (up to 12 months), and at study end (up to 12 months)	No
Secondary	Overall Survival (OS)		Continuously until study end (up to 12 months)	No
Secondary	Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST)		At Baseline, every 8 weeks during treatment (up to 12 months), and at study end (up to 12 months)	No