Know Cancer

or
forgot password

Phase I Study of Concurrent Bevacizumab (Avastin) With Involved-field Thoracic Radiotherapy for Inoperable Non-squamous Non-small Cell Lung Cancer, Followed by Both Concurrent and Maintenance Bevacizumab


Phase 1
N/A
N/A
Not Enrolling
Both
Toxicity

Thank you

Trial Information

Phase I Study of Concurrent Bevacizumab (Avastin) With Involved-field Thoracic Radiotherapy for Inoperable Non-squamous Non-small Cell Lung Cancer, Followed by Both Concurrent and Maintenance Bevacizumab

Inclusion Criteria


Inclusion criteria:

1. Cytologically or histologically confirmed stages II or III non-squamous NSCLC

2. No evidence of tumour invading major blood vessels and no active hemoptysis (bright
red blood of at least ½ teaspoon) in the 28 days prior to randomization.

3. No prior systemic therapy for NSCLC. Prior surgery and/or extra-thoracic irradiation
is permitted.

4. Presence of at least one measurable target lesion

5. Age 18 or greater.

6. WHO performance status of 0 or 1.

7. Acceptable pulmonary function as defined by a Fev1 of ≥30% and a DLCO of ≥40% of
predicted

8. Life expectancy of at least 12 weeks.

9. Adequate hematological, renal and hepatic functions

- Absolute neutrophil count >2x109/l.

- Platelet count > 100x109/l.

- Total bilirubin < 1.5 x UNL

- ASAT/ALAT < 2 x UNL

- Alkaline phosphatase < 5 x UNL

- Creatinine < 130 μmol/L

- Creatinine clearance > 60 ml/min; measured or calculated

10. Urine dipstick for proteinuria < 1+. If urine dipstick is ≥ 1, 24 hour urine must
demonstrate < 500 mg of protein in 24 hours.

11. No pre-existing sensory neurotoxicity grade 2 (CTC)

12. No active (uncontrolled) infection requiring antibiotics

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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To establish the safety and tolerability of 2 dose-levels of bevacizumab administered every 3 weeks with concurrent thoracic radiotherapy to 66 Gy,and also maintenance (15 mg/kg) bevacizumab following completion of thoracic radiotherapy

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Suresh Senan, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

VU University Medical Center

Authority:

Netherlands: Medical Ethics Review Committee (METC)

Study ID:

VUMC 2006/194

NCT ID:

NCT00531076

Start Date:

October 2007

Completion Date:

January 2010

Related Keywords:

  • Toxicity
  • bevacizumab
  • thoracic radiotherapy
  • locally-advanced non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location