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

NCT ID: NCT02694536

Last Updated: 2017-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-01
• Study Completion Date: 2009-11-19

Brief 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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Erlotinib + Gemcitabine

Participants will receive erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason.

Group Type: EXPERIMENTAL

Erlotinib

Intervention Type: DRUG

Participants will receive erlotinib tablets as 100 milligrams (mg) orally (PO) once daily.

Gemcitabine

Intervention Type: DRUG

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.

Interventions

Erlotinib

Participants will receive erlotinib tablets as 100 milligrams (mg) orally (PO) once daily.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Tarceva

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed adenocarcinoma with locally advanced, unresectable, or metastatic disease
• No prior systemic treatment for metastatic disease
• Adjuvant therapy ≥6 months prior to study entry with no residual toxic effects
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

Bari, Apulia, Italy

Napoli, Campania, Italy

Bologna, Emilia-Romagna, Italy

Pordenone, Friuli Venezia Giulia, Italy

Rome, Lazio, Italy

Pavia, Lombardy, Italy

Catania, Sicily, Italy

Pisa, Tuscany, Italy

Perugia, Umbria, Italy

Cona (Ferrara), Veneto, Italy

Verona, Veneto, Italy

Countries

Italy

Other Identifiers

2005-004605-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ML19537

Identifier Type: -

Identifier Source: org_study_id