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Completed

NCT Number: NCT00674973

A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer

This study is designed to identify biomarkers which may predict improvement in progression free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who failed one prior regimen of standard chemotherapy or who are deemed unsuitable for chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient population. Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po daily. Tumor tissue will be used for biomarker analysis. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

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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 2

Primary location

Kogarah, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult patients, >=18 years of age;
  • histologically or cytologically documented locally advanced-unresectable or metastatic pancreatic cancer;
  • measurable disease according to RECIST;
  • failure of at least one prior chemotherapy regimen, or who are deemed unsuitable for chemotherapy;
  • ECOG performance status of 0-2.

Exclusion criteria

  • local or locally advanced-resectable pancreatic cancer;
  • any other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;
  • major surgery within 2 weeks prior to randomization.

Treatment and study plan

Erlotinib

Drug

Participants received erlotinib 150 mg tablet orally once daily.

Other names: Tarceva

Placebo

Drug

Participants received placebo matching to erlotinib 150 mg tablet orally once daily.

Primary outcomes

  1. Progression-Free Survival

    Time frame: From the time of randomization until progression of disease or death (up to 30 months)

    Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first occurrence of PD or death whichever occurred first. Participants without event were censored at the date of last tumor assessment where non-progression was documented. Analysis was performed using Kaplan-Meier method.

Secondary outcomes

  1. Percentage of Participants With Best Overall Response Rate

    Time frame: From the time of randomization until progression of disease or death (up to 30 months)

    Response rate was defined as Complete Response (CR) or Partial Response (PR), according to response evaluation criteria in solid tumors (RECIST) Version 1.0 criteria, for at least 4 weeks at any time during randomized treatment (confirmed response). CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.

  2. Percentage of Participants With Disease Control Rate (DCR)

    Time frame: Randomization to Clinical Cutoff: 20 December 2010 (up to 30 months)

    Disease control rates (DCR) were measured according to RECIST Version 1.0 criteria. Disease control was defined as being a responder or as having stable disease for at least 6 weeks post-randomization. Stable disease was defined as having neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.

  3. Overall Survival

    Time frame: From the time of randomization until or death (up to 30 months)

    Overall survival was defined as the time from the date of randomization to the date of death, regardless of the cause of death.

  4. Number of Participants With Adverse Events (AEs)

    Time frame: Up to 28 days after discontinuation of study drug (up to 30 months)

    An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a study treatment, regardless of whether or not the event had a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Phase II Biomarker Identification Trial for Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Carcinoma

Important dates

Study start
2008
Primary completion
2010
Study completion
2015
First posted
May 8, 2008
Registry last updated
Jun 17, 2016

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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