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A Dose-Escalation to Rash Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
This study is currently recruiting participants.
Verified by Hoffmann-La Roche, August 2009
First Received: April 1, 2008   Last Updated: August 26, 2009   History of Changes
Sponsored by: Hoffmann-La Roche
Information provided by: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00652366
  Purpose

This study will compare the efficacy and safety of escalating versus standard doses to rash of Tarceva, in combination with gemcitabine, in patients with metastatic pancreatic cancer. During a 4 week run-in period, all patients will receive Tarceva 100mg/day po plus gemcitabine 1000mg/m2 iv on days 1, 8,15 and 22. After 4 weeks, patients who have not developed rash, or only develop grade 1 rash, will be randomized to one of 2 groups. Group

1 will receive a starting dose of Tarceva 150mg po daily, increased in steps of 50mg every 2 weeks up to a maximum of 250mg/day po, until development of grade 2 rash or other dose-limiting toxicity. Group 2 will continue to receive Tarceva 100mg/day po. All patients will continue to receive gemcitabine 1000mg/m2 iv on days 1, 8 and 15 of each 4 week cycle. 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 II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Open-label, Dose-escalation to Rash Study to Assess the Effect of Tarceva in Combination With Gemcitabine on Overall Survival in Patients With Metastatic Pancreatic Cancer.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival; response and disease control rates according to RECIST [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • Adverse events, lab parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment: 176
Study Start Date: April 2009
Estimated Study Completion Date: January 2012
Arms Assigned Interventions
1: Experimental Drug: erlotinib [Tarceva]
100mg po daily escalating to a maximum of 250mg po daily
Drug: gemcitabine
1000mg/m2 iv on days 1,8 and 15 of each 4 week cycle
2: Active Comparator Drug: erlotinib [Tarceva]
100mg po daily
Drug: gemcitabine
1000mg/m2 iv on days 1,8 and 15 of each 4 week cycle

  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;
  • histologically or cytologically confirmed pancreatic cancer with measurable or non-measurable metastatic disease;
  • ECOG performance status of 0-1.

Exclusion Criteria:

  • local, or locally advanced, pancreatic cancer;
  • prior systemic treatment for metastatic pancreatic cancer;
  • <=6 months since last adjuvant chemotherapy;
  • other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00652366

Contacts
Contact: Please reference Study ID Number: BO21128 973-235-5000
Contact: or 800-526-6367 (FOR US ONLY)

  Show 85 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche, +1 973 235 5000
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers: BO21128, 2007-003751-37
Study First Received: April 1, 2008
Last Updated: August 26, 2009
ClinicalTrials.gov Identifier: NCT00652366     History of Changes
Health Authority: Italy:National Institue of Health

Study placed in the following topic categories:
Erlotinib
Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Immunologic Factors
Pancreatic Neoplasms
Endocrine System Diseases
Protein Kinase Inhibitors
Immunosuppressive Agents
Antiviral Agents
Exanthema
Digestive System Diseases
Radiation-Sensitizing Agents
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

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

ClinicalTrials.gov processed this record on September 10, 2009