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

NCT ID: NCT00652366

Last Updated: 2015-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 467 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2012-02-29

Brief Summary

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine, Erlotinib Standard Dose

Participants received erlotinib, 100 milligrams (mg), orally (PO), once daily until disease progression or unacceptable toxicity. Participants also received gemcitabine, 1000 mg per (/) square meter (m\^2), intravenously (IV), on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression or unacceptable toxicity.

Group Type: ACTIVE_COMPARATOR

Erlotinib, standard dose

Intervention Type: DRUG

100mg, PO, once daily

Gemcitabine

Intervention Type: DRUG

1000 mg/m2, IV, on days 1,8 and 15 of each 4 week cycle

Gemcitabine, Erlotinib Escalating Dose

Participants received erlotinib, beginning at 150 mg/day, PO, once daily, and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal. Participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

Erlotinib, escalating dose

Intervention Type: DRUG

100mg, PO, once daily, escalating to a maximum of 250mg, PO, once daily

Gemcitabine

Intervention Type: DRUG

1000 mg/m2, IV, on days 1,8 and 15 of each 4 week cycle

Interventions

Erlotinib, escalating dose

100mg, PO, once daily, escalating to a maximum of 250mg, PO, once daily

Intervention Type: DRUG

Erlotinib, standard dose

100mg, PO, once daily

Intervention Type: DRUG

Gemcitabine

1000 mg/m2, IV, on days 1,8 and 15 of each 4 week cycle

Intervention Type: DRUG

Other Intervention Names

Tarceva; Tarceva

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Buenos Aires, , Argentina

Rosario, , Argentina

San Juan Bautista, , Argentina

Santa Fe, , Argentina

Canberra, Australian Capital Territory, Australia

Liverpool, New South Wales, Australia

St Leonards, New South Wales, Australia

Sydney, New South Wales, Australia

Brisbane, Queensland, Australia

Adelaide, South Australia, Australia

Ballarat, Victoria, Australia

Frankston, Victoria, Australia

Salzburg, , Austria

Vienna, , Austria

Antwerp, , Belgium

Brussels, , Belgium

Ghent, , Belgium

Leuven, , Belgium

Liège, , Belgium

Salvador, Estado de Bahia, Brazil

Belo Horizonte, Minas Gerais, Brazil

Ijuí, Rio Grande do Sul, Brazil

Santo André, São Paulo, Brazil

São Paulo, São Paulo, Brazil

Mississauga, Ontario, Canada

Toronto, Ontario, Canada

Zagreb, , Croatia

Copenhagen, , Denmark

Herlev, , Denmark

Hillerød, , Denmark

Angers, , France

Besançon, , France

Brest, , France

Paris, , France

Saint-Priest-en-Jarez, , France

Berlin, , Germany

Bochum, , Germany

Bonn, , Germany

Esslingen am Neckar, , Germany

Halle, , Germany

Hamburg, , Germany

Hamm, , Germany

Kaiserslautern, , Germany

Leipzig, , Germany

Marburg, , Germany

Mönchengladbach, , Germany

München, , Germany

Saarbrücken, , Germany

Trier, , Germany

Ulm, , Germany

Heraklion, , Greece

Thessaloniki, , Greece

Hong Kong, , Hong Kong

Hong Kong, , Hong Kong

Haifa, , Israel

Jerusalem, , Israel

Petah Tikva, , Israel

Tel Aviv, , Israel

Ẕerifin, , Israel

Chieti, Abruzzo, Italy

San Giovanni Rotondo, Apulia, Italy

Napoli, Campania, Italy

Pordenone, Friuli Venezia Giulia, Italy

Udine, Friuli Venezia Giulia, Italy

Orbassano, Piedmont, Italy

Florence, Tuscany, Italy

Vilnius, , Lithuania

Vilnius, , Lithuania

Distrito Federal, , Mexico

Gliwice, , Poland

Lublin, , Poland

Poznan, , Poland

Warsaw, , Poland

Brasov, , Romania

Bucharest, , Romania

Cluj-Napoca, , Romania

Sibiu, , Romania

Belgrade, , Serbia

Kamenitz, , Serbia

Singapore, , Singapore

Singapore, , Singapore

Madrid, Madrid, Spain

Madrid, Madrid, Spain

Madrid, Madrid, Spain

Madrid, Madrid, Spain

Taipei, , Taiwan

Taipei, , Taiwan

London, , United Kingdom

Salisbury, , United Kingdom

Countries

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

Other Identifiers

2007-003751-37

Identifier Type: -

Identifier Source: secondary_id

BO21128

Identifier Type: -

Identifier Source: org_study_id