Clinical trial NCT00652366: A Dose-Escalation to Rash Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 467
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants Who Died Assessed From Point of Randomization
timeFrame: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.
measure: OS Assessed From Point of Randomization
timeFrame: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.
Secondary outcomes:
measure: Percentage of Participants With Disease Progression or Death as Assessed From Point of Randomization
timeFrame: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.
measure: PFS Assessed From Point of Randomization
timeFrame: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.
measure: Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST
timeFrame: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.
measure: Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST
timeFrame: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.
measure: Percentage of Participants With SD (Maintained for at Least 8 Weeks) or CR or PR (Maintained for at Least 4 Weeks) According to RECIST
timeFrame: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.
measure: Percentage of Participants Who Died as Assessed From Start of 4-Week Run-In
timeFrame: BL and weekly thereafter for up to 46 months.
measure: OS Assessed From Start of 4-Week Run-In
timeFrame: BL and weekly thereafter for up to 46 months.
measure: Percentage of Participants With Disease Progression or Death as Assessed From the Start of 4-Week Run-In
timeFrame: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months.
measure: PFS Assessed From the Start of 4-Week Run-In
timeFrame: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months.
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Florencio Varela
country: Argentina
city: Rosario
country: Argentina
city: Santa Fe
country: Argentina
city: Canberra
country: Australia
state: Australian Capital Territory
city: Liverpool
country: Australia
state: New South Wales
city: St. Leonards
country: Australia
state: New South Wales
city: Sydney
country: Australia
state: New South Wales
city: Brisbane
country: Australia
state: Queensland
city: Adelaide
country: Australia
state: South Australia
city: Ballarat
country: Australia
state: Victoria
city: Frankston
country: Australia
state: Victoria
city: Salzburg
country: Austria
city: Wien
country: Austria
city: Antwerpen
country: Belgium
city: Bruxelles
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Salvador
country: Brazil
state: BA
city: Belo Horizonte
country: Brazil
state: MG
city: Ijui
country: Brazil
state: RS
city: Santo Andre
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Mississauga
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Zagreb
country: Croatia
city: Herlev
country: Denmark
city: Hillerod
country: Denmark
city: København
country: Denmark
city: Angers
country: France
city: Besancon
country: France
city: Brest
country: France
city: Paris
country: France
city: St-Priest-En-Jarez
country: France
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Bonn
country: Germany
city: Esslingen
country: Germany
city: Halle
country: Germany
city: Hamburg
country: Germany
city: Hamm
country: Germany
city: Kaiserslautern
country: Germany
city: Leipzig
country: Germany
city: Marburg
country: Germany
city: Muenchen
country: Germany
city: Mönchengladbach
country: Germany
city: Saarbruecken
country: Germany
city: Trier
country: Germany
city: Ulm
country: Germany
city: Heraklion
country: Greece
city: Thessaloniki
country: Greece
city: Hong Kong
country: Hong Kong
city: Hong Kong
country: Hong Kong
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Petach Tikva
country: Israel
city: Tel Aviv
country: Israel
city: Zerifin
country: Israel
city: Chieti
country: Italy
state: Abruzzo
city: Napoli
country: Italy
state: Campania
city: Pordenone
country: Italy
state: Friuli-Venezia Giulia
city: Udine
country: Italy
state: Friuli-Venezia Giulia
city: Orbassano
country: Italy
state: Piemonte
city: San Giovanni Rotondo
country: Italy
state: Puglia
city: Firenze
country: Italy
state: Toscana
city: Vilnius
country: Lithuania
city: Vilnius
country: Lithuania
city: Distrito Federal
country: Mexico
city: Gliwice
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Brasov
country: Romania
city: Bucuresti
country: Romania
city: Cluj Napoca
country: Romania
city: Sibiu
country: Romania
city: Belgrade
country: Serbia
city: Sremska Kamenica
country: Serbia
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: London
country: United Kingdom
city: Salisbury
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: