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

Roche

Status and phase: Completed; Phase 3

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Treatments: Drug: cisplatin; Drug: pemetrexed; Drug: bevacizumab [Avastin]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00961415

2008-007008-27

MO22089

Details and patient eligibility

About

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.

Enrollment: 376 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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376 participants in 3 patient groups

Part 1

Experimental group

Treatment:

Drug: bevacizumab [Avastin]

Drug: cisplatin

Drug: pemetrexed

Part 2A

Experimental group

Treatment:

Drug: bevacizumab [Avastin]

Part 2B

Active Comparator group

Treatment:

Drug: bevacizumab [Avastin]

Drug: pemetrexed