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Trial record 7 of 23 for:    Pancreatic Cancer | ( Map: Hong Kong )

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

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ClinicalTrials.gov Identifier: NCT00674973
Recruitment Status : Completed
First Posted : May 8, 2008
Results First Posted : April 26, 2016
Last Update Posted : June 17, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Erlotinib Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Biomarker Identification Trial for Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Carcinoma
Study Start Date : June 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Erlotinib
Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until disease progression, unacceptable toxicity, withdrawal, or death.
Drug: Erlotinib
Participants received erlotinib 150 mg tablet orally once daily.
Other Name: Tarceva

Placebo Comparator: Placebo
Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression, unacceptable toxicity, withdrawal, or death.
Drug: Placebo
Participants received placebo matching to erlotinib 150 mg tablet orally once daily.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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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:

  • 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.

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): NCT00674973


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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00674973     History of Changes
Other Study ID Numbers: BO21129
2007-003738-40 ( EudraCT Number )
First Posted: May 8, 2008    Key Record Dates
Results First Posted: April 26, 2016
Last Update Posted: June 17, 2016
Last Verified: May 2016
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
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action