A Dose-Escalation to Rash Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00652366
First received: April 1, 2008
Last updated: August 15, 2012
Last verified: August 2012

April 1, 2008
August 15, 2012
May 2008
Not Provided
Overall survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00652366 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Dose-Escalation to Rash Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
  • Drug: erlotinib [Tarceva]
    100mg po daily escalating to a maximum of 250mg po daily
  • Drug: erlotinib [Tarceva]
    100mg po daily
  • Drug: gemcitabine
    1000mg/m2 iv on days 1,8 and 15 of each 4 week cycle
  • Experimental: 1
    Interventions:
    • Drug: erlotinib [Tarceva]
    • Drug: gemcitabine
  • Active Comparator: 2
    Interventions:
    • Drug: erlotinib [Tarceva]
    • Drug: gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
467
April 2012
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Croatia,   Denmark,   France,   Germany,   Greece,   Hong Kong,   Israel,   Italy,   Lithuania,   Mexico,   Poland,   Romania,   Serbia,   Singapore,   Spain,   Taiwan,   United Kingdom
 
NCT00652366
BO21128, 2007-003751-37
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP