Clinical trial NCT00700180: A Study of Avastin (Bevacizumab) in Combination With Carboplatin-Based Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer.
Official title: A Randomized, Open-label Study to Explore the Correlation of Biomarkers With Response Rate in Chemo-naive Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer Who Receive Treatment With Avastin in Addition to Carboplatin-based Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-06-18
Enrollment: 303
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 explore the correlation of biomarkers with response rate, and the overall efficacy and safety, of Avastin in combination with carboplatin-based chemotherapy in patients with advanced or recurrent non-squamous non-small cell lung cancer. Patients will be randomized to one of 2 groups, to receive either Avastin 7.5mg/kg iv on day 1 of each 3 week cycle, or Avastin 15mg/kg iv on day 1 of each 3 week cycle; all patients will also receive treatment with carboplatin and either gemcitabine or paclitaxel for a maximum of 6 cycles. 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;
* locally advanced metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC);
* \>=1 measurable tumor lesion;
* ECOG performance status 0-1.

Exclusion Criteria:

* prior chemotherapy or treatment with another systemic anti-cancer agent;
* evidence of CNS metastases;
* history of grade 2 or higher hemoptysis;
* evidence of tumor invading or abutting major blood vessels;
* malignancies other than NSCLC within 5 years prior to randomization, other than adequately treated cancer in situ of cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS;
* clinically significant cardiovascular disease;
* current or recent use of aspirin (\>325mg/day) or full dose anticoagulants or thrombolytic agents for therapeutic purposes.

Primary outcomes:
measure: Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Dichotomized Baseline Plasma Marker Level
timeFrame: Baseline, Day 21 of Cycles 2, 4, and 6 (Bv + chemo), Day 21 of Cycles 7, 8, 9, and 10 (Bv), Day 21 of every other cycle (Bv), and at disease progression.
Secondary outcomes:
measure: Progression-Free Survival - Percentage of Participants With an Event
timeFrame: Baseline, Day 1, weekly to disease progression
measure: Progression-Free Survival - Time to Event
timeFrame: Baseline, Day 1, weekly to disease progression
measure: Percentage of Participants With Objective Response
timeFrame: Baseline, Day 21 of Cycles 2, 4, and 6, Day 21 of Cycles 7, 8, 9, and 10, Day 21 of every other cycle, and at disease progression
measure: Percentage of Participants With Measurable Disease at Baseline Who Achieved CR, PR, or Stable Disease (SD) for at Least 6 Weeks
timeFrame: Baseline, Day 21 of Cycles 2, 4, and 6, Day 21 of Cycles 7, 8, 9, and 10, Day 21 of every other cycle, and at disease progression
measure: Duration of Response - Percentage of Participants With an Event
timeFrame: Baseline, Day 21 of Cycles 2, 4, and 6, Day 21 of Cycles 7, 8, 9, and 10, Day 21 of every other cycle, and at disease progression
measure: Duration of Response - Time to Event
timeFrame: Baseline, Day 21 of Cycles 2, 4, and 6 (Bv + chemo), Day 21 of Cycles 7, 8, 9, and 10 (Bv), Day 21 of every other cycle (Bv), and at disease progression.
measure: Overall Survival - Percentage of Participants With an Event
timeFrame: Baseline, weekly to 28 days after last dose of study treatment, every 8 weeks thereafter to death due to any cause
measure: Overall Survival - Time to Event
timeFrame: Baseline, weekly to death due to any cause, or to end of study
Other outcomes:
Locations:
city: St. Leonards
country: Australia
state: New South Wales
city: Adelaide
country: Australia
state: South Australia
city: Adelaide
country: Australia
state: South Australia
city: Box Hill
country: Australia
state: Victoria
city: Fitzroy
country: Australia
state: Victoria
city: Antwerpen
country: Belgium
city: Liege
country: Belgium
city: Vancouver
country: Canada
state: British Columbia
city: Toronto
country: Canada
state: Ontario
city: Ostrava
country: Czech Republic
city: Praha
country: Czech Republic
city: Odense
country: Denmark
city: Paris
country: France
city: Rouen
country: France
city: Bad Berka
country: Germany
city: Grosshansdorf
country: Germany
city: Hamburg
country: Germany
city: Oldenburg
country: Germany
city: Hong Kong
country: Hong Kong
city: Hong Kong
country: Hong Kong
city: Budapest
country: Hungary
city: Edeleny
country: Hungary
city: Sopron
country: Hungary
city: Szombathely
country: Hungary
city: Torokbalint
country: Hungary
city: Milano
country: Italy
city: Milan
country: Italy
city: Orbassano
country: Italy
city: Roma
country: Italy
city: Den Haag
country: Netherlands
city: Enschede
country: Netherlands
city: Hoorn
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Rotterdam
country: Netherlands
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Zabrze
country: Poland
city: Arkhangelsk
country: Russian Federation
city: Chelyabinsk
country: Russian Federation
city: Kazan
country: Russian Federation
city: Kazan
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Barakaldo
country: Spain
state: Vizcaya
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Changhua
country: Taiwan
city: Taichung
country: Taiwan
city: Taichung
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Aberdeen
country: United Kingdom
city: Chelmsford
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: