NCT01963351CompletedNot Applicable
Open-label Study of Bevacizumab (AVASTIN®) in Combination With Platinum-containing Chemotherapy as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer
University of Athens1 site in 1 country150 target enrollmentStarted: January 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Number of adverse events during 24 months of follow-up
Study Overview
Brief Summary
This observational trial is designed to assess the safety profile and tolerability of bevacizumab when combined with chemotherapy as first-line treatment of advanced or recurrent non-squamous NSCLC.
Detailed Description
It is an observational study for the safety and tolerability of the combination of bevacizumab with chemotherapy in locally advanced or metastatic and recurrent non-squamous non-small cell lung cancer. We try to evaluate the safety of bevacizumab in real life population with lung cancer. For patients with performance status 0-1 platinum based chemotherapy was recommended and acceptable doses of bevacizumab was either 7.5 or 15 mg/kgr. Safety profile was evaluated with Common Toxicity criteria v 3.0. Especially for bevacizumab we evaluate specific situations as thrombotic or hemorrhagic events, hypertension, albuminuria, and gastrointestinal disorders.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Written informed consent
- •Age ≥18 years
- •Able to comply with the protocol
- •Histologically or cytologically documented, locally advanced, metastatic (Stage IV) or recurrent non-squamous NSCLC 5.ECOG PS: 0-2
- •Life expectancy ≥12 weeks
- •Adequate haematological function:
- •Absolute neutrophil count (ANC) ≥1.5 x 109/L AND
- •Platelet count ≥100 x 109/L AND
- •Haemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level)
- •Adequate liver function:
- •Total bilirubin <1.5 x upper limit of normal (ULN) AND
- •Asparagine aminotransferase (AST), alanine aminotransferase (ALT) <2.5 x ULN in patients without liver metastases; <5 x ULN in patients with liver metastases
- •Adequate renal function: calculated creatinine clearance ≥50 mL/min AND
- •Urine dipstick for proteinuria <2+.
- •INR ≤1.5 and partial prothrombin time (PTT or aPTT) ≤1.5 x ULN within 7 days prior to enrolment
- •If female, should not be pregnant or breast-feeding. Women with an intact uterus (unless amenorrhoeic for the last 24 months) must have a negative serum pregnancy test within 28 days prior to enrolment into the study
Exclusion Criteria
- •Mixed, predominant squamous component
- •History of haemoptysis, in the 3 months prior to enrolment
- •Evidence of tumour invading major blood vessels
- •Evidence of CNS metastases, even if previously treated. If suspected, the patient should be scanned within 28 days prior to enrolment to rule out CNS metastases
- •Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrolment
- •Radical radiotherapy with curative intent within 28 days prior to enrolment. Palliative radiotherapy f is allowed
- •Major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment
- •Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion
- •Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (> 325mg/day)
- •Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed
- •History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
- •Uncontrolled hypertension
- •Clinically significant (i.e. active) cardiovascular disease
- •Non-healing wound, active peptic ulcer or bone fracture
- •History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment
- •Women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective, means of contraception Men who do not agree to use effective contraception during the study
- •Known hypersensitivity to bevacizumab or any of its excipients, and any of the chemotherapies
- •Evidence of ongoing or active infection, any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
- •Patients diagnosed with a tracheo-esophageal fistula
- •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 treated surgically with curative intent, DCIS treated surgically with curative intent
- •History of thrombotic disorders within the last 6 months prior to enrollment.
Outcomes
Primary Outcomes
Number of adverse events during 24 months of follow-up
Time Frame: 24 months
Secondary Outcomes
- Overall survival(24 months)
Investigators
Kostas N Syrigos
Professor in Medical Oncology
University of Athens
Study Sites (1)
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