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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 ]

Enrollment: 467
Study Start Date: May 2008
Study Completion Date: April 2012
Arms Assigned Interventions
Experimental: 1 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
Active Comparator: 2 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

  Hide Study Locations
Locations
Argentina
Buenos Aires, Argentina, B1878DVB
Buenos Aires, Argentina, C1264AAA
Rosario, Argentina, S2000PBJ
Santa Fe, Argentina, 03000
Australia
Adelaide, Australia, 5000
Ballarat, Australia, 03350
Brisbane, Australia, 4101
Canberra, Australia, 2606
Frankston, Australia, 3199
Liverpool, Australia, 2170
St. Leonards, Australia, 2065
Sydney, Australia, 2076
Austria
Salzburg, Austria, 5020
Wien, Austria, 1090
Belgium
Antwerpen, Belgium, 2020
Bruxelles, Belgium, 1070
Gent, Belgium, 9000
Leuven, Belgium, 3000
Liege, Belgium, 4000
Brazil
Belo Horizonte, Brazil, 30110-0090
Ijuí, Brazil, 98700-000
Salvador, Brazil, 40170-110
Santo Andre, Brazil, 09060-870
São Paulo, Brazil, 01246-902
Canada, Ontario
Mississauga, Ontario, Canada, L5M 2N1
Toronto, Ontario, Canada, M5G 2M9
Croatia
Zagreb, Croatia, 10000
Denmark
Herlev, Denmark, 2730
Hillerød, Denmark, 3400
København, Denmark, 2100
France
Angers, France, 49933
Besancon, France, 25030
Brest, France, 29609
Paris, France, 75679
St-priest-en-jarez, France, 42271
Germany
Berlin, Germany, 13353
Bochum, Germany, 44791
Bonn, Germany, 53127
Esslingen, Germany, 79730
Halle, Germany, 06120
Hamburg, Germany, 22081
Hamm, Germany, 59071
Kaiserslautern, Germany, 67655
Leipzig, Germany, 04103
Marburg, Germany, 35043
Mönchengladbach, Germany, 41063
München, Germany, 81377
Saarbrücken, Germany, 66113
Trier, Germany, 54290
ULM, Germany, 89081
Greece
Heraklion, Greece, 71110
Thessaloniki, Greece, 56439
Hong Kong
Hong Kong, Hong Kong, 852
Hong Kong, Hong Kong
Israel
Haifa, Israel, 31096
Jerusalem, Israel, 91120
Petach Tikva, Israel, 49100
Tel Aviv, Israel, 64239
Zerifin, Israel, 70300
Italy
Chieti, Italy, 66100
Firenze, Italy, 50139
Napoli, Italy, 80131
Orbassano, Italy, 10043
Pordenone, Italy, 33170
San Giovanni Rotondo, Italy, 71013
Udine, Italy, 33100
Lithuania
Vilnius, Lithuania, 08661
Vilnius, Lithuania, 08660
Mexico
Mexico City, Mexico, 14000
Poland
Gliwice, Poland, 44-101
Lublin, Poland, 20-081
Poznan, Poland, 61-878
Warszawa, Poland, 02-781
Romania
Brasov, Romania, 2200
Bucuresti, Romania, 022328
Cluj Napoca, Romania, 400015
Sibiu, Romania, 550245
Serbia
Belgrade, Serbia, 11000
Sremska Kamenica, Serbia, 21204
Singapore
Singapore, Singapore, 119074
Singapore, Singapore, 169610
Spain
Madrid, Spain, 28033
Madrid, Spain, 28034
Madrid, Spain, 28223
Madrid, Spain, 28050
Taiwan
Taipei, Taiwan, 100
Taipei, Taiwan, 112
United Kingdom
London, United Kingdom, SE1 9RT
Salisbury, United Kingdom, SP2 8BJ
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00652366     History of Changes
Other Study ID Numbers: BO21128, 2007-003751-37
Study First Received: April 1, 2008
Last Updated: August 15, 2012
Health Authority: Italy:National Institue of Health

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
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 April 16, 2014