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2006-08-01
2009-11-19
2009-11-19
80
NCT02694536
Hoffmann-La Roche
Hoffmann-La Roche
INTERVENTIONAL
A Study of Erlotinib in Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-02-24 | 2016-09-12 | 2017-02-21 |
2016-02-24 | 2016-11-11 | 2017-03-24 |
2016-02-29 | 2017-01-10 | 2017-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Erlotinib + Gemcitabine Participants will receive erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. | DRUG: Erlotinib
DRUG: Gemcitabine
|
| Primary Outcome Measures | 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 | 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) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
