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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.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00461708
First received: April 17, 2007
Last updated: February 15, 2011
Last verified: February 2011
History of Changes
  Purpose

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:

U.S. FDA Resources

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 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

  Eligibility

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

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

Locations
Spain
Alcorcon, Spain, 28922
Alcoy, Spain, 3804
Barcelona, Spain, 08907
Barcelona, Spain, 08227
Barcelona, Spain, 08906
Barcelona, Spain, 08916
Córdoba, Spain, 14004
El Palmar Murcia, Spain, 30120
Elche, Spain, 03202
Girona, Spain, 17007
Granada, Spain, 18014
Guadalajara, Spain, 19002
Jaen, Spain, 23007
La Coruna, Spain, 15006
Lleida, Spain, 25198
Lugo, Spain, 27004
Madrid, Spain, 28040
Madrid, Spain, 28041
Manresa, Spain, 08243
Murcia, Spain, 30008
Navarra, Spain, 31008
Palma de Mallorca, Spain, 07198
Pontevedra, Spain, 36002
Sabadell, Barcelona, Spain, 08208
Sagunto, Spain, 46520
Santander, Spain, 39008
Sevilla, Spain, 41013
Valencia, Spain, 41014
Zaragoza, Spain, 50009
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00461708     History of Changes
Other Study ID Numbers: ML20296
Study First Received: April 17, 2007
Last Updated: February 15, 2011
Health Authority: Spain: Agencia Espanola del Medicamento (AEM)

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

ClinicalTrials.gov processed this record on May 22, 2013