Bevacizumab in Combination With Chemotherapy in Patients With Advanced or Recurrent Non-squamous NSCLC

NCT01963351 | Completed DMC

• 1 other identifier: ML27816
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer; Unresectable Malignant Neoplasm

Keywords

NSCLC; Non-squamous

Outcome Measures

Primary Outcomes (1)

• Number of adverse events during 24 months of follow-up

  24 months

Secondary Outcomes (1)

• Overall survival

  24 months

Other Outcomes (1)

• Progression free survival

  24 months

Study Arms (1)

Locally advanced and metastatic nsclc

non squamous

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically or cytologically documented advanced metastatic (patients who are not candidates for radiotherapy, i.e. supraclavicular lymph node metastases or Stage IIIb with malignant pleural or pericardial effusion or Stage IV) or recurrent non-squamous non-small cell lung cancer.

You may qualify if:

• \. Written informed consent 2. Age ≥18 years 3. Able to comply with the protocol 4. Histologically or cytologically documented, locally advanced, metastatic (Stage IV) or recurrent non-squamous NSCLC 5.ECOG PS: 0-2 6. Life expectancy ≥12 weeks 7. 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) 8. 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 9. Adequate renal function: calculated creatinine clearance ≥50 mL/min AND
• Urine dipstick for proteinuria \<2+. 10. INR ≤1.5 and partial prothrombin time (PTT or aPTT) ≤1.5 x ULN within 7 days prior to enrolment 11. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

Oncology Unit Sotiria Hospital of Chest Diseases

Athens, 115 27, Greece

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kostas N Syrigos, Professor

  Oncology Unit University of Athens, Sotiria Hosp, 152 Mesogion Av

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Medical Oncology

Study Record Dates

• First Submitted: September 19, 2013
• First Posted: October 16, 2013
• Study Start: January 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: December 8, 2014

Record last verified: 2014-12

Locations

GR (1)