Status:
COMPLETED
Bevacizumab in Extensive Small Cell Lung Cancer
Lead Sponsor:
Intergroupe Francophone de Cancerologie Thoracique
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
Despite the fact that a substantial response rate may be obtained in small-cell lung cancers (using double-drug chemotherapy: cisplatin-etoposide, PE), a cure remains an exception. More aggressive reg...
Eligibility Criteria
Inclusion
- Inclusion Criteria (must be checked at the inclusion, week -8):
- Small-Cell Lung Cancer histologically or cytologically proved
- Extended disease as defined by Veteran's Administration Lung Cancer Group (VALG)
- At least one unidimensionally measurable lesion (RECIST criterion)
- Age between 18 and 75 years
- Weight loss \< 10% for the last three month
- Performance Status (PS)≤ 2
- Creatininemia \< 110 µmol/L and creatinin clearance \> 60 mL/min
- Neutrophils ≥ 1,500/µL and platelets ≥ 100,000/µL
- Bilirubin ≤ 1.5 x normal value
- Transaminases, Alkaline Phosphatase ≤ 2.5 x ULN excepted in case of liver metastasis (5xULN)
- Left ventricular ejection fraction (measured by echocardiographic or isotopic method) \> 50% if PCDE is planned
- Electrocardiogram without uncontrolled coronaropathy
- Signed informed consent
- Randomization Criteria (to be checked during the randomization (week 0)):
- Partial or complete tumoral response as defined by RECIST
- All chemotherapy-induced toxicities decreased to level ≤ 2 as defined by NCI CTC VS 3 (except for alopecia)
- Inclusion criteria concerning creatininemia, clearance, neutrophils, platelets, transaminases, alkaline phosphatases and left ventricular ejection fraction must be checked again
- Exclusion Criteria:
- Non-Small-Cell Lung Cancer or mixed cancer (small-cell / non-small-cell)
- Previous antitumoral treatment of the small-cell lung cancer (chemotherapy, radiotherapy, immunotherapy, surgery)
- Non-extended disease as defined by VALG
- Natremia \< 125 mmol/L
- Hypercalcemia whereas a corrective treatment
- Pathology contra-indicating the hyper-hydration
- Hemoptysis in the last three months
- Tumor invading large vessels or invading the proximal trachea-bronchial tree (visible at the medical imagery). Investigator or radiologist must reject tumors adjoining, merging or extending to large vessel's lumen (for example : pulmonary artery, superior vena cava)
- Symptomatic cerebral or meningeal metastasis
- Other cancer in progress or medical history of cancer in the five last years (excepted basal cell carcinoma or in situ cervical cancer of the uterus.
- Important surgical intervention (including surgical biopsy), traumatic lesion during 28 days before starting the treatment, or anticipation of an important surgical intervention during the study
- Minor surgical intervention, including implanting permanent catheter during the 24 hours before the first administration of bevacizumab
- Unhealed wound, evolutive gastroduodenal ulcer, fractured bone
- Medical history of abdominal fistula, trachea-oesophageal fistula, of another type with a severity rank of 4, gastrointestinal perforation or intraabdominal abscess during 6 month before inclusion
- Ongoing or recent use of aspirin (during 10 days before the first administration of bevacizumab) (\>325 mg/day) or use of another platelet aggregation inhibitor (dipyridamole, ticlopidine, clopidogrel \> 75 mg/day), or ongoing or recent use of a therapeutic dose (during 10 days before the first administration of bevacizumab) of anticoagulant or thrombolytic drugs per os or in parenteral injection. Prophylactic use of anticoagulant drug is allowed
- Medical history or genetic predisposition to bleeding or coagulopathy
- Clinically significative cardiac disease: infarct or CVA during 6 month before inclusion, unstable angina, congestive cardiac failure level \> II as defined by New York Heart Association (NYHA) or cardiac arrythmia needing a specific treatment which risk to interfere with the study, or uncontrolled arrythmia.
- Known allergy or hypersensibility to monoclonal antibodies (bevacizumab), to chinese hamster ovary cells or to any humanized or recombinant antibody
- Uncontrolled high blood pressure (systolic pressure \> 150 mm Hg and/or diastolic pressure \> 100 mm Hg), with or without hypotension treatment. Patients presenting an high blood pressure are eligibles if their treatment can decrease their blood pressure to the values required by the protocol.
- Severe ongoing infectious disease or fever \> 38.5°C or evidence of any other pathology, organic or neurologic functions deterioration, physical examination or laboratory result which cause suspicion of a disease which contra-indicate use of any studied treatment.
- Woman with a positive pregnancy test or who has not made a pregnancy test (unless pregnancy risk can be excluded)
- Lactating woman
- Sexually active woman who don't use hormonal or mechanical contraceptive method or sexually active man who has a sexually active partner who don't want to use an effective contraceptive method during the course of the study and during the 6 months after last treatment administration
- Patient who as already been included and treated in the present study
- Patient who participate or who has participated in another study during 4 weeks before treatment administration
- Patient who receive a previous antiangiogenic treatment (experimental or commercial : bevacizumab, thalidomide, CP-547632, sunitinib, sorafenib...)
- Geographical or psychological condition which not allowed a good comprehension or compliance to protocol
- Liberty deprived patient
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT00930891
Start Date
September 1 2009
End Date
July 1 2013
Last Update
March 10 2016
Active Locations (60)
Enter a location and click search to find clinical trials sorted by distance.
1
Annemasse - CH
Ambilly, France, 74100
2
Angers - CHU
Angers, France, 49000
3
Armentières - CH
Armentières, France
4
CHU Besancon - Pneumologie
Besançon, France, 25000