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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: Erlotinib
* Drug: Gemcitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erlotinib + Gemcitabine<br>Participants will receive erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. | Drug: Erlotinib<br>* Participants will receive erlotinib tablets as 100 milligrams (mg) orally (PO) once daily.<br>* Other names: Tarceva;Drug: Gemcitabine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to approximately 40 months (assessed continuously during treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Up to approximately 40 months (assessed continuously through end of study) | 
| Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST) | Tumor assessments were performed using RECIST. Disease progression was defined as greater than or equal to (≥) 20 percent (%) increase in sum of longest diameters (LD) of target lesions in reference to smallest sum of LD on study. The percentage of participants who died or demonstrated disease progression was reported to the nearest integer. | Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study) | 
| Progression-Free Survival (PFS) According to RECIST | Tumor assessments were performed using RECIST. PFS was defined as the time from treatment start to the time of death or disease progression. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum of LD on study. PFS was estimated by Kaplan-Meier methodology and expressed in months. | Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study) |