Clinical trial NCT00940875: A Study of Tarceva (Erlotinib) in Sequential Combination With Gemcitabine as First Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer
Official title: A Randomized, Open-label Study of the Effect of First Line Treatment With Tarceva in Sequential Combination With Gemcitabine, Compared to Gemcitabine Monotherapy, on Progression-free Survival in Elderly or ECOG PS of 2 Patients With Advanced Non-small Cell Lung Cancer.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-07-16
Enrollment: 54
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 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva and gemcitabine, and of gemcitabine monotherapy, as first line treatment of elderly patients, or patients with ECOG performance status of 2, with advanced non-small cell lung cancer.Patients will be randomized to receive either sequential gemcitabine 1250mg/m2/day on days 1 and 8 + Tarceva 150mg po on days 15-28 of each 4 week cycle, or gemcitabine monotherapy 1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=70 years of age or with ECOG PS of 2;
* advanced (stage IIIB or IV)non-small cell lung cancer;
* no prior systemic chemotherapy for advanced NSCLC or prior treatment with HER-axis targeted drugs.

Exclusion Criteria:

* active brain metastasis or spinal cord suppression;
* unstable systemic disease.

Primary outcomes:
measure: Percentage of Participants With Disease Progression or Death
timeFrame: BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant).
measure: PFS
timeFrame: BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (up to 2 years)
Secondary outcomes:
measure: Percentage of Participants Who Achieved Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0
timeFrame: BL, Day 22 of Cycle 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant).
measure: Percentage of Participants With Non-Progression at Weeks 8 and 16
timeFrame: Weeks 8 and 16
measure: Percentage of Participants Who Died
timeFrame: BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.
measure: Overall Survival (OS)
timeFrame: BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.
measure: Duration of Response
timeFrame: BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.
Other outcomes:
Locations:
city: Port Macquarie
country: Australia
state: New South Wales
city: Randwick
country: Australia
state: New South Wales
city: Sydney
country: Australia
state: New South Wales
city: Sydney
country: Australia
state: New South Wales
city: Tweed Heads
country: Australia
state: New South Wales
city: Wollongong
country: Australia
state: New South Wales
city: Brisbane
country: Australia
state: Queensland
city: Greenslopes
country: Australia
state: Queensland
city: Woolloongabba
country: Australia
state: Queensland
city: Richmond
country: Australia
state: South Australia
city: Terrace Gardens
country: Australia
state: South Australia
city: Hobart
country: Australia
state: Tasmania
city: Bendigo
country: Australia
state: Victoria
city: Heidelberg
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Wodonga
country: Australia
state: Victoria
city: Fremantle
country: Australia
state: Western Australia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: