Back to resultsA Study of Erlotinib in Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Erlotinib
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Erlotinib + Gemcitabine
Arm Description
Participants will receive erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Percentage of Participants Who Died
The percentage of participants who died from any cause was reported to the nearest integer.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02694536
Brief Title
A Study of Erlotinib in Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer
Official Title
A Phase IIIb Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2006 (undefined)
Primary Completion Date
November 19, 2009 (Actual)
Study Completion Date
November 19, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Erlotinib + Gemcitabine
Arm Type
Experimental
Arm Description
Participants will receive erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason.
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva
Intervention Description
Participants will receive erlotinib tablets as 100 milligrams (mg) orally (PO) once daily.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events (AEs)
Description
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 Outcome Measure Information:
Title
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
Description
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)
Title
Percentage of Participants Who Died
Description
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)
Title
Overall Survival (OS)
Description
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.
Time Frame
Up to approximately 40 months (assessed continuously through end of study)
Title
Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST)
Description
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.
Time Frame
Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)
Title
Progression-Free Survival (PFS) According to RECIST
Description
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.
Time Frame
Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
City
Pordenone
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33170
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00144
Country
Italy
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95126
Country
Italy
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56100
Country
Italy
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06156
Country
Italy
City
Cona (Ferrara)
State/Province
Veneto
ZIP/Postal Code
44124
Country
Italy
City
Verona
State/Province
Veneto
ZIP/Postal Code
37126
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
A Study of Erlotinib in Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer
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