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A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00642733
Recruitment Status : Terminated (poor recruitment)
First Posted : March 25, 2008
Last Update Posted : August 24, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This single arm study will assess the efficacy and safety of Tarceva + gemcitabine in patients with locally advanced, unresectable or metastatic pancreatic cancer. Patients will receive Tarceva 100mg po daily, in combination with gemcitabine 1000mg/m2 iv weekly for 8 weeks, followed by weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: erlotinib [Tarceva] Drug: gemcitabine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study to Evaluate the Effect of First Line Treatment With Tarceva in Combination With Gemcitabine on Overall Survival and Disease Progression in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Study Start Date : August 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Arm Intervention/treatment
Experimental: 1 Drug: erlotinib [Tarceva]
100mg po daily

Drug: gemcitabine
1000mg/m2 iv weekly for 8 weeks, then weekly for 3 weeks of each 4 week cycle

Primary Outcome Measures :
  1. Overall survival; time to progression [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Duration of response; disease-free survival [ Time Frame: Event driven ]
  2. AEs, lab parameters [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • pancreatic cancer, surgically unresectable or with metastases;
  • no previous chemotherapy (except concomitant with radiotherapy);
  • ECOG 0-2.

Exclusion Criteria:

  • pancreatic cancer without histologic or cytologic confirmation;
  • surgical resection possible;
  • previous chemotherapy not concomitant with radiotherapy;
  • ECOG 3-4.

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 identifier (NCT number): NCT00642733

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Morelia, Mexico, 58070
Tijuana, Mexico, 22320
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche Identifier: NCT00642733    
Other Study ID Numbers: ML21285
First Posted: March 25, 2008    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Erlotinib Hydrochloride
Antimetabolites, Antineoplastic
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