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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

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ClinicalTrials.gov Identifier: NCT00961415
Recruitment Status : Completed
First Posted : August 19, 2009
Results First Posted : February 22, 2016
Last Update Posted : February 22, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

August 18, 2009
August 19, 2009
November 30, 2015
February 22, 2016
February 22, 2016
August 2009
May 2011   (Final data collection date for primary outcome measure)
Progression Free Survival During Maintenance Treatment Phase [ Time Frame: Up to 21 months ]
Progression free survival (PFS) is defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) , or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Progression is defined using (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions.Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.
Progression-free survival [ Time Frame: tumour assessment before cycle 3, at 2nd cycle of maintenance therapy and every 9 weeks thereafter ]
Complete list of historical versions of study NCT00961415 on ClinicalTrials.gov Archive Site
  • Overall Survival During Maintenance Treatment Phase [ Time Frame: Up to 21 months ]
    Overall survival (OS) is assessed from the date of first induction treatment until the date of death. Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.
  • Best Overall Response Rate During Maintenance Treatment Phase [ Time Frame: Up to 21 months ]
    The best overall response rate (BORR) is defined as the percentage of participants having achieved confirmed Complete Response (CR) and Partial Response (PR) as the best overall response. CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a greater than or equal to (≥) 30% decrease under baseline of the sum of diameters of all target lesions. Stable disease (SD) is defined as steady state of disease with neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.
  • Duration of Response During Maintenance Treatment Phase [ Time Frame: Up to 21 months ]
    Duration of response is defined as the time in months from the initial start of response PR or better to the earlier of documented PD or death due to any cause. Participants who had neither progressed nor died at the date of clinical cutoff, who withdrew from the study, were lost to follow-up, or were without documented disease progression were censored at the date of the last available tumor assessment. The analysis was based on all participants with measurable disease at baseline who achieved response.Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.
  • Duration of Disease Control During Maintenance Treatment Phase [ Time Frame: Up to 21 months ]
    Duration of disease control is defined as the time in months from randomization to the earlier of documented PD or death due to any cause. Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.
  • Incidence of Adverse Events and Serious Adverse Event [ Time Frame: Up to 21 months ]
    An adverse events (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect, or precaution.
  • Number of Participants With Marked Laboratory Abnormalities [ Time Frame: Up to 21 months ]
    Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from Baseline. The reference range for Platelets was 100-550 (10^9/L), for White blood cells (WBC) was 3.0-18.0 (10^9/L), for Lymphocytes was 0.70-7.60 (10^9/L), and Neutrophil 1.50-9.25 (10^9/L ).
  • Quality of Life [ Time Frame: Up to 21 months ]
    European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Cancer 30 (EORTC QLQ-C30): included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). The European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Lung Cancer 13 [EORTC QLQ-LC13]consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity. QOL was assessed using Pre-Induction Baseline (Pre-ind BL), Maintenance (MTC), End of study (EOS) cycles.
  • 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 ]
  • Safety and tolerability: AEs, laboratory parameters [ Time Frame: throughout study, laboratory assessments every 3 weeks ]
  • Quality of life [ Time Frame: EORTC-QLQ assessments every 2 cycles ]
Not Provided
Not Provided
 
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
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)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-Squamous Non-Small Cell Lung Cancer
  • Drug: bevacizumab [Avastin]
    7.5mg/kg iv on day 1 of each 3-week cycle
  • Drug: cisplatin
    75mg/m2 iv on day 1 of each 3-week cycle
  • Drug: pemetrexed
    500mg/m2 iv on day 1 of each 3-week cycle
  • Experimental: Part 1
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: cisplatin
    • Drug: pemetrexed
  • Experimental: Part 2A
    Intervention: Drug: bevacizumab [Avastin]
  • Active Comparator: Part 2B
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: pemetrexed
Barlesi F, Scherpereel A, Rittmeyer A, Pazzola A, Ferrer Tur N, Kim JH, Ahn MJ, Aerts JG, Gorbunova V, Vikström 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
376
362
May 2011
May 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Greece,   Italy,   Korea, Republic of,   Netherlands,   Russian Federation,   Spain,   Sweden,   Switzerland,   Turkey,   United Arab Emirates
Kuwait,   Portugal
 
NCT00961415
MO22089
2008-007008-27
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP