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

Roche

Status and phase: Completed; Phase 3

Conditions: Pancreatic Cancer

Treatments: Drug: Gemcitabine; Drug: Erlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02694536

2005-004605-29 (EudraCT Number)

ML19537

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Erlotinib + Gemcitabine

Experimental group

Description:

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

Treatment:

Drug: Erlotinib

Drug: Gemcitabine