A Study of Tarceva (Erlotinib) in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas: Relationship Between Skin Toxicity and Survival

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: April 17, 2007
Last updated: June 3, 2013
Last verified: June 2013

This single arm study will evaluate the relationship between the skin toxicity of Tarceva in combination with gemcitabine, and survival, in patients with advanced and/or metastatic pancreatic cancer. All patients will receive gemcitabine 100mg/m2 i.v. weekly; Tarceva will be administered 100mg po per day. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Condition Intervention Phase
Pancreatic Cancer
Drug: erlotinib [Tarceva]
Drug: Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study of Tarceva in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas : Relationship Between Skin Rash and Survival

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Relationship between grade 2 Tarceva-related skin rash and >=6 months survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PFS, 6 month survival, time to treatment failure, objective response rate, duration of response. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 156
Study Start Date: May 2007
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: erlotinib [Tarceva]
100mg po daily
Drug: Gemcitabine
100mg/m2 iv weekly


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • locally advanced and/or metastatic pancreatic cancer (stage III or IV);
  • Karnofsky performance Status of >=60%.

Exclusion Criteria:

  • local(stage IA to IIB) pancreatic cancer;
  • <=6 months since last adjuvant chemotherapy;
  • previous systemic therapy for metastatic pancreatic cancer;
  • other primary tumor within last 5 years (except for adequately treated cancer in situ of cervix, or basal cell skin cancer);
  • clinically significant cardiovascular disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461708

Alcoy, Alicante, Spain, 03804
Elche, Alicante, Spain, 03203
Manresa, Barcelona, Spain, 08243
Sabadell, Barcelona, Barcelona, Spain, 08208
Santander, Cantabria, Spain, 39008
Palma de Mallorca, Islas Baleares, Spain, 07198
La Coruna, La Coruña, Spain, 15006
Alcorcon, Madrid, Spain, 28922
Sagunto, Valencia, Spain, 46520
Barcelona, Spain, 08907
Barcelona, Spain, 08906
Barcelona, Spain, 08227
Barcelona, Spain, 08916
Cordoba, Spain, 14004
Girona, Spain, 17007
Granada, Spain, 18014
Guadalajara, Spain, 19002
Jaen, Spain, 23007
Lerida, Spain, 25198
Lugo, Spain, 27004
Madrid, Spain, 28040
Madrid, Spain, 28041
Murcia, Spain, 30008
Murcia, Spain, 30120
Navarra, Spain, 31008
Pontevedra, Spain, 36002
Sevilla, Spain, 41013
Valencia, Spain, 41014
Zaragoza, Spain, 50009
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00461708     History of Changes
Other Study ID Numbers: ML20296
Study First Received: April 17, 2007
Last Updated: June 3, 2013
Health Authority: Spain: Agencia Espanola del Medicamento (AEM)

Additional relevant MeSH terms:
Neoplasm Metastasis
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Site
Neoplastic Processes
Pancreatic Diseases
Pathologic Processes
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 06, 2015