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

Hoffmann-La Roche80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer

Interventions

ErlotinibDRUG

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

GemcitabineDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Unnamed facility

Bari, Apulia, Italy

Unnamed facility

Naples, Campania, Italy

Unnamed facility

Bologna, Emilia-Romagna, Italy

Unnamed facility

Pordenone, Friuli Venezia Giulia, Italy

Outcomes

Primary Outcomes

Percentage of Participants With Adverse Events (AEs)

An AE was defined as any untoward medical occurrence and which did not necessarily have a causal relationship with treatment. The percentage of participants who experienced at least 1 AE was reported.

Time frame: Up to approximately 40 months (assessed continuously during treatment)

Secondary Outcomes

European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores

The QLQ-C30 is a 30-item questionnaire that assesses physical (Questions 1-5), role (Questions 6-7), emotional (Questions 21-24), cognitive (Questions 20 and 25), and social (Questions 26-27) functional domains as well as global health status (Questions 29-30) and several symptoms including fatigue (Questions 10, 12, and 18), pain (Questions 9 and 19), nausea/vomiting (Questions 14-15), dyspnea (Question 8), appetite loss (Question 13), insomnia (Question 11), constipation/diarrhea (Questions 16-17), and financial difficulties (Question 28). Questions 1 to 28 were assessed on a 4-point scale from 1 ("no/not at all") to 4 ("very much") where higher scores represented worse symptoms. Questions 29 and 30 were assessed on a 7-point scale from 1 ("very poor") to 7 ("excellent") where higher scores represented better functioning. Item scores over the study period were averaged among all participants across all visits for which data were available.

Time frame: Up to approximately 40 months (assessed at Baseline, every 4 weeks during treatment, and end of study)

Percentage of Participants Who Died

The percentage of participants who died from any cause was reported to the nearest integer.

Time frame: Up to approximately 40 months (assessed continuously through end of study)

Overall Survival (OS)

OS was defined as the time from start of treatment to time of death from any cause. Participants who had not died at the time of final analysis were censored at the date of last contact. OS was estimated by Kaplan-Meier methodology and expressed in months.

Data from ClinicalTrials.gov

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