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OpenTrials
Completed

NCT Number: NCT02694536

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bari, Apulia, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erlotinib

Drug

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

Other names: Tarceva

Gemcitabine

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Feb 29, 2016
Registry last updated
Mar 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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