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

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ClinicalTrials.gov Identifier: NCT02694536
Recruitment Status : Completed
First Posted : February 29, 2016
Results First Posted : January 10, 2017
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Erlotinib Drug: Gemcitabine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IIIb Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Study Start Date : August 1, 2006
Actual Primary Completion Date : November 19, 2009
Actual Study Completion Date : November 19, 2009


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

Drug: Gemcitabine
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 Measures :
  1. Percentage of Participants With Adverse Events (AEs) [ Time Frame: Up to approximately 40 months (assessed continuously during treatment) ]
    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 :
  1. European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores [ Time Frame: Up to approximately 40 months (assessed at Baseline, every 4 weeks during treatment, and end of study) ]
    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.

  2. Percentage of Participants Who Died [ Time Frame: Up to approximately 40 months (assessed continuously through end of study) ]
    The percentage of participants who died from any cause was reported to the nearest integer.

  3. Overall Survival (OS) [ Time Frame: Up to approximately 40 months (assessed continuously through end of study) ]
    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.

  4. Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study) ]
    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.

  5. Progression-Free Survival (PFS) According to RECIST [ Time Frame: Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02694536


Locations
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Italy
Napoli, Campania, Italy, 80131
Bologna, Emilia-Romagna, Italy, 40138
Pordenone, Friuli-Venezia Giulia, Italy, 33170
Roma, Lazio, Italy, 00144
Pavia, Lombardia, Italy, 27100
Bari, Puglia, Italy, 70124
Catania, Sicilia, Italy, 95126
Pisa, Toscana, Italy, 56100
Perugia, Umbria, Italy, 06156
Cona (Ferrara), Veneto, Italy, 44124
Verona, Veneto, Italy, 37126
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02694536     History of Changes
Other Study ID Numbers: ML19537
2005-004605-29 ( EudraCT Number )
First Posted: February 29, 2016    Key Record Dates
Results First Posted: January 10, 2017
Last Update Posted: March 24, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Erlotinib Hydrochloride
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors