Clinical trial NCT00961415: AVAPERL1 Study: A Study of Avastin (Bevacizumab) With or Without Pemetrexed as Maintenance Therapy After Avastin in First Line in Patients With Non-Squamous Non-Small Cell Lung Cancer
Official title: Open-label Study of Bevacizumab Maintenance Therapy (AVASTIN®) With or Without Pemetrexed After First-line Chemotherapy With Bevacizumab-cisplatin-pemetrexed in Patients With Advanced, Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-08-19
Enrollment: 376
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 open-label study will assess the efficacy and safety of Avastin with or without pemetrexed as maintenance therapy in patients with advanced, metastatic or recurrent non-small cell lung cancer. In Part 1, patients will receive 4 cycles of treatment with Avastin (7.5mg/kg iv) plus cisplatin (75mg/m2 iv) plus pemetrexed (500mg/m2 iv) on day 1 of each 3-week cycle. In Part 2, patients responding to treatment will be randomized to receive further treatment cycles of Avastin (7.5mg/kg iv every 3 weeks) with or without pemetrexed (500mg/m2 iv every 3 weeks). Anticipated time on study treatment is until disease progression. Target sample size is \<500 individuals.


Eligibility criteria: Inclusion Criteria:

* adults \>/=18 years of age
* inoperable, locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC)
* at least 1 measurable lesion meeting RECIST criteria
* ECOG performance status 0-2
* adequate hematological, liver and renal function

Exclusion Criteria:

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

Primary outcomes:
measure: Progression Free Survival During Maintenance Treatment Phase
timeFrame: Up to 21 months
Secondary outcomes:
measure: Overall Survival During Maintenance Treatment Phase
timeFrame: Up to 21 months
measure: Best Overall Response Rate During Maintenance Treatment Phase
timeFrame: Up to 21 months
measure: Duration of Response During Maintenance Treatment Phase
timeFrame: Up to 21 months
measure: Duration of Disease Control During Maintenance Treatment Phase
timeFrame: Up to 21 months
measure: Incidence of Adverse Events and Serious Adverse Event
timeFrame: Up to 21 months
measure: Number of Participants With Marked Laboratory Abnormalities
timeFrame: Up to 21 months
measure: Quality of Life
timeFrame: Up to 21 months
Other outcomes:
Locations:
city: Beziers
country: France
city: Bordeaux
country: France
city: Bron
country: France
city: Caen
country: France
city: Caen
country: France
city: Clermont-ferrand
country: France
city: Creteil
country: France
city: GAP
country: France
city: Gleize
country: France
city: La Source
country: France
city: La Tronche
country: France
city: Lille
country: France
city: Limoges
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Nancy
country: France
city: Nimes
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Perpignan
country: France
city: Pierre Benite
country: France
city: Reims
country: France
city: Saint Priest En Jarez
country: France
city: Strasbourg
country: France
city: Toulon
country: France
city: Tours
country: France
city: Augsburg
country: Germany
city: Bad Berka
country: Germany
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Ebensfeld
country: Germany
city: Frankfurt
country: Germany
city: Freiburg
country: Germany
city: Gauting
country: Germany
city: Grosshansdorf
country: Germany
city: Halle (Saale)
country: Germany
city: Hamburg
country: Germany
city: Immenhausen
country: Germany
city: Karlsruhe
country: Germany
city: Leipzig
country: Germany
city: Minden
country: Germany
city: Muenchen
country: Germany
city: Oldenburg
country: Germany
city: Alexandroupolis
country: Greece
city: Napoli
country: Italy
state: Campania
city: Aviano
country: Italy
state: Friuli-Venezia Giulia
city: Roma
country: Italy
state: Lazio
city: Novara
country: Italy
state: Piemonte
city: Lecce
country: Italy
state: Puglia
city: Sassari
country: Italy
state: Sardegna
city: Pisa
country: Italy
state: Toscana
city: Padova
country: Italy
state: Veneto
city: Bundang City
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Amersfoort
country: Netherlands
city: Amsterdam
country: Netherlands
city: Breda
country: Netherlands
city: Den Haag
country: Netherlands
city: Eindhoven
country: Netherlands
city: Haarlem
country: Netherlands
city: Hertogenbosch
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Rotterdam
country: Netherlands
city: Sittard-Geleen
country: Netherlands
city: Zaandam
country: Netherlands
city: Balashikha
country: Russian Federation
city: Irkutsk
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Moscow
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Palma de Mallorca
country: Spain
state: Islas Baleares
city: Las Palmas de Gran Canaria
country: Spain
state: Las Palmas
city: La Laguna
country: Spain
state: Tenerife
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Gävle
country: Sweden
city: Linköping
country: Sweden
city: Lund
country: Sweden
city: Uppsala
country: Sweden
city: Zürich
country: Switzerland
city: Antalya
country: Turkey
city: Izmir
country: Turkey
city: Al Ain
country: United Arab Emirates
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Barlesi F, Scherpereel A, Rittmeyer A, Pazzola A, Ferrer Tur N, Kim JH, Ahn MJ, Aerts JG, Gorbunova V, Vikstrom A, Wong EK, Perez-Moreno P, Mitchell L, Groen HJ. Randomized phase III trial of maintenance bevacizumab with or without pemetrexed after first-line induction with bevacizumab, cisplatin, and pemetrexed in advanced nonsquamous non-small-cell lung cancer: AVAPERL (MO22089). J Clin Oncol. 2013 Aug 20;31(24):3004-11. doi: 10.1200/JCO.2012.42.3749. Epub 2013 Jul 8.