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Randomized Phase II-III Study of Bevacizumab 7,5 mg/kg in Combination With Chemotherapy Versus Chemotherapy in Extensive-Disease Small-Cell Lung Cancer After Response to Chemotherapy : PCDE (cisPlatin - Cyclophosphamide - epiDoxorubicin - Etoposide) or PE (cisPlatin - Etoposide)

Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling)
Small Cell Lung Cancer

Thank you

Trial Information

Randomized Phase II-III Study of Bevacizumab 7,5 mg/kg in Combination With Chemotherapy Versus Chemotherapy in Extensive-Disease Small-Cell Lung Cancer After Response to Chemotherapy : PCDE (cisPlatin - Cyclophosphamide - epiDoxorubicin - Etoposide) or PE (cisPlatin - Etoposide)

Inclusion Criteria

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (complete response + partial response)

Outcome Time Frame:

6 weeks after randomization

Safety Issue:


Principal Investigator

Jean-Louis PUJOL, Pr

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHRU Montpellier


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

September 2009

Completion Date:

December 2013

Related Keywords:

  • Small Cell Lung Cancer
  • Extensive-Disease Small-Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma