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

NCT00652366 | Completed Phase 2 Results

• 2 other identifiers: BO211282007-003751-37
• Study Type: interventional
• Target: 467
• Locations: 22 countries
• Sites: 81

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

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who Died Assessed From Point of Randomization

  Overall survival (OS) assessed from the point of randomization was defined as the time from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive.

  Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.

• OS Assessed From Point of Randomization

  OS assessed from the point of randomization was defined as the median time, in months, from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. The 95 percent (%) confidence interval (CI) was determined using Kaplan-Meier methodology.

  Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.

Secondary Outcomes (9)

• Percentage of Participants With Disease Progression or Death as Assessed From Point of Randomization

  Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.

• PFS Assessed From Point of Randomization

  Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.

• Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST

  BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.

• Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST

  BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.

• Percentage of Participants With SD (Maintained for at Least 8 Weeks) or CR or PR (Maintained for at Least 4 Weeks) According to RECIST

  BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.

Study Arms (2)

Gemcitabine, Erlotinib Standard Dose

ACTIVE COMPARATOR

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.

Drug: Erlotinib, standard dose; Drug: Gemcitabine

Gemcitabine, Erlotinib Escalating Dose

EXPERIMENTAL

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.

Drug: Erlotinib, escalating dose; Drug: Gemcitabine

Interventions

Erlotinib, escalating dose DRUG

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

Also known as: Tarceva

Gemcitabine, Erlotinib Escalating Dose

Erlotinib, standard dose DRUG

100mg, PO, once daily

Also known as: Tarceva

Gemcitabine, Erlotinib Standard Dose

Gemcitabine DRUG

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

Gemcitabine, Erlotinib Escalating Dose; Gemcitabine, Erlotinib Standard Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (89)

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Buenos Aires, C1264AAA, Argentina

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Rosario, S2000PBJ, Argentina

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San Juan Bautista, B1878DVB, Argentina

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Santa Fe, 03000, Argentina

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Canberra, Australian Capital Territory, 2606, Australia

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Liverpool, New South Wales, 2170, Australia

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St Leonards, New South Wales, 2065, Australia

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Sydney, New South Wales, 2076, Australia

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Brisbane, Queensland, 4101, Australia

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Adelaide, South Australia, 5000, Australia

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Ballarat, Victoria, 03350, Australia

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Frankston, Victoria, 3199, Australia

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Salzburg, 5020, Austria

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Vienna, 1090, Austria

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Antwerp, 2020, Belgium

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Brussels, 1070, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Salvador, Estado de Bahia, 40170-110, Brazil

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Belo Horizonte, Minas Gerais, 30110-0090, Brazil

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Ijuí, Rio Grande do Sul, 98700-000, Brazil

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Santo André, São Paulo, 09060-650, Brazil

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São Paulo, São Paulo, 01246-000, Brazil

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Mississauga, Ontario, L5M 2N1, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Zagreb, 10000, Croatia

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Copenhagen, 2100, Denmark

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Herlev, 2730, Denmark

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Hillerød, 3400, Denmark

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Angers, 49933, France

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Besançon, 25030, France

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Brest, 29609, France

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Paris, 75679, France

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Saint-Priest-en-Jarez, 42271, France

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Berlin, 13353, Germany

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Bochum, 44791, Germany

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Bonn, 53127, Germany

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Esslingen am Neckar, 73730, Germany

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Halle, 06120, Germany

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Hamburg, 22081, Germany

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Hamm, 59071, Germany

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Kaiserslautern, 67655, Germany

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Leipzig, 04103, Germany

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Marburg, 35043, Germany

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Mönchengladbach, 41063, Germany

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München, 81377, Germany

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Saarbrücken, 66113, Germany

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Trier, 54290, Germany

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Ulm, 89081, Germany

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Heraklion, 71110, Greece

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Thessaloniki, 56439, Greece

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Hong Kong, 852, Hong Kong

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Hong Kong, Hong Kong

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Haifa, 34354, Israel

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Jerusalem, 91120-01, Israel

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Petah Tikva, 49100, Israel

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Tel Aviv, 64239-06, Israel

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Ẕerifin, 70300, Israel

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Chieti, Abruzzo, 66100, Italy

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San Giovanni Rotondo, Apulia, 71013, Italy

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Napoli, Campania, 80131, Italy

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Pordenone, Friuli Venezia Giulia, 33170, Italy

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Udine, Friuli Venezia Giulia, 33100, Italy

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Orbassano, Piedmont, 10043, Italy

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Florence, Tuscany, 50139, Italy

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Vilnius, 08660, Lithuania

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Vilnius, 08661, Lithuania

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Distrito Federal, 14080, Mexico

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Gliwice, 44-101, Poland

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Lublin, 20-081, Poland

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Poznan, 60-569, Poland

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Warsaw, 02-781, Poland

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Brasov, 2200, Romania

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Bucharest, 022328, Romania

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Cluj-Napoca, 400015, Romania

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Sibiu, 550245, Romania

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Belgrade, 11000, Serbia

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Kamenitz, 21204, Serbia

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Singapore, 119228, Singapore

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Singapore, 169610, Singapore

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Madrid, Madrid, 28033, Spain

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Madrid, Madrid, 28034, Spain

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Madrid, Madrid, 28050, Spain

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Madrid, Madrid, 28223, Spain

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Taipei, 00112, Taiwan

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Taipei, 100, Taiwan

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London, SE1 9RT, United Kingdom

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Salisbury, SP2 8BJ, United Kingdom

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MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Erlotinib Hydrochloride; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 3, 2008
• Study Start: May 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 11, 2015
• Results First Posted: February 11, 2015

Record last verified: 2015-01

Locations

IL (5); IT (7); BR (5); PL (4); TW (2); CR (1); DK (3); DE (15); FR (5); GR (2); AU (2); ES (4); CA (2); SE (2); SG (2); AR (4); RO (4); GB (2); HK (2); LI (2); ME (1); BE (5)