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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00961415
First received: August 18, 2009
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This open-label study will assess the efficacy and safety of Avastin with or wit hout 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 pemetre xed (500mg/m2 iv) on day 1 of each 3-week cycle. In Part 2, patients responding to treatment will be randomized to receive further treament 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 sampl e size is <500 individuals.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: bevacizumab [Avastin]
Drug: cisplatin
Drug: pemetrexed
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: tumour assessment before cycle 3, at 2nd cycle of maintenance therapy and every 9 weeks thereafter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate, disease control rate,duration of response, overall survival [ Time Frame: tumour assessment before cycle 3, at 2nd cycle of maintenance therapy and every 9 weeks thereafter ] [ Designated as safety issue: No ]
  • Safety and tolerability: AEs, laboratory parameters [ Time Frame: throughout study, laboratory assessments every 3 weeks ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: EORTC-QLQ assessments every 2 cycles ] [ Designated as safety issue: No ]

Enrollment: 343
Study Start Date: July 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1 Drug: bevacizumab [Avastin]
7.5mg/kg iv on day 1 of each 3-week cycle
Drug: cisplatin
75mg/kg iv on day 1 of each 3-week cycle
Drug: pemetrexed
500mg/m2 iv on day 1 of each 3-week cycle
Experimental: Part 2A Drug: bevacizumab [Avastin]
7.5mg/kg iv on day 1 of each 3-week cycle
Active Comparator: Part 2B Drug: bevacizumab [Avastin]
7.5mg/kg iv on day 1 of each 3-week cycle
Drug: pemetrexed
500mg/m2 iv on day 1 of each 3-week cycle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults >/=18 years of age
  • inoperable, locally advanced, metastatic or recurrent non-squamous 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 cracinoma in situ of the cervix, basal or squameous cell skin cancer, localized prostate cancer or DCIS
  • evidence of tumour 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00961415

  Show 91 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00961415     History of Changes
Other Study ID Numbers: MO22089, 2008-007008-27
Study First Received: August 18, 2009
Last Updated: August 26, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Bevacizumab
Pemetrexed
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on September 16, 2014