Bevacizumab Plus Chemotherapy for Advanced Non Small Cell Lung Cancer Patients as 1st Line Treatment

NCT01934465 | Completed

• 1 other identifier: CT/10.11
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 8

Brief Summary

Investigators propose to assess, retrospectively and prospectively the safety and tolerability profile (number of participants with adverse events) of standard chemotherapy and anti-angiogenic agent bevacizumab (Avastin) as first line treatment of patients with advanced or metastatic Non Small Cell Lung Cancer. All treatment schedules that are going to be assessed are considered by the international guidelines as standard therapy for patients with advanced or metastatic Non Small Cell Lung Cancer.

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC; Chemotherapy; Anti-angiogenic agent; Bevacizumab; 1st Line

Outcome Measures

Primary Outcomes (1)

• Number of Participants with AE

  In this observational study investigators are going to assess standard schedules in which administrations were every 3 weeks.

  Every 3 weeks up to 18 weeks

Secondary Outcomes (3)

• Number of Participants with Response Rate

  Disease evaluation at Week 6

• Percentage of Patients with Progression Free Survival

  1 year

• Patients Overall Survival

  1 year

Study Arms (1)

Avastin regimens

Patients who have either received or who are going to receive chemotherapy plus Avastin (bevacizumab)

Eligibility Criteria

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

Study Population

Clinics for cancer prevention

You may qualify if:

• Signed informed consent prior to initiation of any trial-specific procedure or treatment
• Ability to comply with the protocol
• Histologically or cytologically (sample to be obtained by biopsy or bronchoscopy) confirmed non-squamous NSCLC (locally recurrent or metastatic) per investigator assessment
• At least 1 unidimensionally measurable lesion meeting RECIST criteria
• No prior first line treatment for metastatic colorectal cancer
• Age ≥18 years
• ECOG performance status ≤2
• Adequate haematological, renal and hepatic function
• Urine protein \<2+ (dipstick)
• International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN within 7 days prior to randomization, unless there is prophylactic use of anti-coagulation
• Patients with asymptomatic treated brain metastases are eligible for trial participation. Patients must complete treatment for brain metastases (radiotherapy with or without surgery, or stereotactic radiosurgery), including steroids, at least 28 days prior to randomization. Treatment with anticonvulsants at the time of randomization (i.e. ≥ 28 days) is allowed as long as the anti-convulsant is at a stable dose)
• Female patients must not be pregnant or breast-feeding. Female patients of childbearing potential (defined as \>2 years after last menstruation or surgically sterile) must use a highly effective contraceptive method (allowed methods of birth control, i.e. with a failure rate of less than 1% per year, are implants, injectables, combined oral contraceptives, intra-uterine device \[IUD; only hormonspirals\], sexual abstinence or vasectomized partner) during the trial and for a period of at least 6 months following the last administration of trial drug(s).Female patients with an intact uterus (unless amenorrhoeic for the last 24 months) must have a negative serum pregnancy test within 7 days prior to randomization into the trial
• Fertile male patients must agree to use a highly effective contraceptive method (allowed methods of birth control, i.e. with a failure rate of less than 1% per year, include a female partner using implants, injectables, combined oral contraceptives, IUDs \[only hormonspirals\], sexual abstinence or prior vasectomy) during the trial and for a period of at least 6 months following the last administration of trial drug(s)

You may not qualify if:

• Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
• History of hemoptysis ≥ grade 2 (defined as bright red blood of at least 2.5 mL) within 3 months prior to randomization
• Surgery (including open biopsy), significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during trial treatment
• Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion
• Evidence of tumor invading or abutting a major blood vessel (e.g., pulmonary artery or superior vena cava) on imaging
• Radiotherapy to any site for any reason within 28 days prior to randomization. Palliative radiotherapy to bone lesions within 14 days prior to randomization is allowed
• Current or recent (within 10 days prior to first dose of bevacizumab) use of aspirin (\> 325 mg/day), clopidogrel (\> 75 mg/day), or current or recent (within 10 days prior to first dose of bevacizumab) use of full-dose (i.e. therapeutic 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 a risk of bleeding
• Active gastrointestinal bleeding
• Inadequately controlled hypertension (blood pressure: systolic \> 150 mmHg and/or diastolic \> 100 mmHg) within 28 days prior to randomization or history of hypertensive crisis or hypertensive encephalopathy
• Clinically significant (i.e. active) cardiovascular disease (e.g. cerebrovascular accident \[CVA\] or myocardial infarction within 6 months prior to randomization, unstable angina, congestive heart failure \[CHF\] New York Heart Association \[NYHA\] Class ≥ II, or serious cardiac arrhythmia), that is uncontrolled by medication or may interfere with administration of trial treatment
• Non-healing wound, active peptic ulcer or untreated bone fracture
• History of abdominal fistula, gastrointestinal perforation or intra abdominal abscess within 6 months prior to randomization.
• Treatment with any other investigational agent within 28 days prior to randomization. Patients in the follow-up phase of 1st-line trials who fulfill all eligibility criteria may be enrolled in this trial if the 1st-line protocol allows bevacizumab-based treatment in the follow-up phase
• Known hypersensitivity to bevacizumab or any of its excipients, or any of the SOC agents foreseen

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead

Study Sites (8)

University Hospital of Crete, Dep of Medical Oncology

Heraklion, Crete, Greece

Location

University General Hospital of Alexandroupolis, Dept. of Medical Oncology

Alexandroupoli, Greece

Location

"IASO" General Hospital of Athens

Athens, Greece

Location

401 Military Hospital of Athens

Athens, Greece

Location

Air Forces Military Hospital of Athens

Athens, Greece

Location

State General Hospital of Larissa, Dep of Medical Oncology

Larissa, Greece

Location

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

Piraeus, Greece

Location

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, Greece

Location

Related Publications (1)

• Matikas A, Kentepozidis Nu, Ardavanis A, Vaslamatzis M, Polyzos A, Emmanouilides Ch, Katsaounis P, Koinis F, Xynogalos S, Christopoulou A, Ziras N, Tegos T, Prinarakis E, Hatzidaki D, Georgoulias V, Kotsakis A; HORG's Lung Cancer Working Group. Efficacy and tolerance of frontline bevacizumab-based chemotherapy for advanced non-small cell lung cancer patients: a multicenter, phase IV study of the Hellenic Oncology Research Group (HORG). Cancer Chemother Pharmacol. 2016 Aug;78(2):369-76. doi: 10.1007/s00280-016-3094-7. Epub 2016 Jun 22.

  PMID: 27335027 DERIVED

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

• Vassilis Georgoulias, MD

  Hellenic Oncology Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2013
• First Posted: September 4, 2013
• Study Start: February 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 24, 2014

Record last verified: 2014-10

Locations

GR (8)