Phase I study of concurrent with involved-field thoracic radiotherapy for inoperable non-squamous cell lung cancer, followed by both concurrent and maintenance Bevacizumab

Withdrawn

Conditions: 10038666
10029107
non-squamous lung cancer
lung cancer

Registration Number: NL-OMON30108

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

Patients aged 18 years or older with histologically- or cytologically-confirmed non-squamous cell carcinoma of the lung (NSCLC);Inoperable stages II*IIIB NSCLC, who have received no previous thoracic radiotherapy AND no chemotherapy or anti-cancer agents for at least 21 days ;WHO performance score of 0-2; acceptable pulmonary function as defined by a Fev1 of *30% and a DLCO of *40% of predicted; no use of anticoagulants.;Patients who are likely to be at low-risk for radiation pneumonitis (V20 < 35%).

Exclusion Criteria

1. Mixed tumor types with small cell lung cancer or squamous cell carcinoma
2. Other serious diseases, such as heart failure, angina pectoris, myocardial infarction within the last 6 months, uncontrolled hypertension
3. Serious non-healing wound or ulcer.
4. ASAT and ALAT > 1,5 x UNL
5. alkaline phosphatase 5 x UNL
6. Evidence of bleeding diathesis or coagulopathy.
7. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.
8. Participation in other trial with investigational drug or treatment modality.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objectives<br /><br><br /><br>To establish the safety and tolerability of<br /><br>1. two doses of bevacizumab 7.5 mg/kg administered every 3 weeks with<br /><br>concurrent thoracic radiotherapy to 66 Gy;<br /><br>2. concurrent (7.5 mg/kg) and maintenance (15 mg/kg) bevacizumab during, and<br /><br>following, completion of thoracic radiotherapy to 66 Gy</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives<br /><br><br /><br>1. Correlate all observed toxicity with dose-volume histograms of irradiated<br /><br>normal organs.<br /><br>2. Explore surrogate tumor end-points that may correlate with the efficacy of<br /><br>combined treatment with anti-VEGF targeted therapy<br /><br>3. Estimate the objective tumor response after radiotherapy and concurrent<br /><br>bevacizumab based on RECIST criteria</p><br>