EUCTR2007-005017-19-FR进行中（未招募）1 期
Open-label, multi-center, randomized, two stage adaptive design study of the combination of bevacizumab with standard chemotherapy in minor patients with metastatic rhabdomyosarcoma, non-rhabdomyosarcoma soft-tissue sarcoma or Ewing’s sarcoma/soft-tissue primitive neuroectodermal tumors.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 154
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Written informed consent of patient/parent/legally acceptable
- •representative (latest approved version by the Independent Ethics Committee
- •[IEC]/Institutional Review Board [IRB]), obtained prior to any study-specific
- •procedures.
- •2. Age prior to treatment start greater than or equal to 2 years and less than or
- •equal to 17 years.
- •3. Newly diagnosed, histologically documented, patients with one of the following
- •Metastatic rhabdomyosarcoma (RMS) - Risk factors (at least two of the RMS
- •specific risk factors are required for the 1st stage of the study):
- •- Patients greater than or equal to 10 years of age.
- •- Bone or bone marrow involvement (considered as 1 site).
- •- More than two different organs with metastatic disease.
- •- Unfavorable primary sites: extremities (including buttocks and shoulder) and
- •Metastatic non-rhabdomyosarcoma soft-tissue sarcoma (NRSTS).
- •Metastatic Ewing’s sarcoma (ES)/soft-tissue primitive neuroectodermal tumor
- •(PNET) - Risk factors (at least one of these ES/PNET specific risk factors is
- •required for the 1st stage of the study):
- •- Bone metastases.
- •- Bone marrow metastases.
- •4. Age-adapted performance status and life expectancy adequate for chemotherapy
- •according to the protocol.
- •5. Adequate bone marrow function:
- •Absolute neutrophil count (ANC) greater than or equal to 1.0 x 1'000'000'000/L
- •and WBC greater than or equal to 2.0 x 1'000'000'000/L.
- •Platelet count greater than or equal to 100 x 1'000'000'000/L (in case of bone
- •marrow involvement greater than or equal to 75 x1'000'000'000/L).
- •Hb > 7.5 g/dL (75g/L - including after transfusion).
- •6. Adequate blood clotting: PT-INR less than or equal to 1.5 and aPTT less than or
- •equal to 1.5 x upper limit of normal (ULN) within 7 days prior to treatment start.
- •7. Adequate liver function:
- •Serum (total) bilirubin less than or equal to 1.5 x ULN.
- •AST and ALT less than or equal to 2.5 x ULN in patients without liver
- •metastases, less than or equal to 5 x ULN in patients with liver metastases.
- •8. Adequate renal function:
- •Serum creatinine < 1.5 x ULN for age; if serum creatinine is > 1.5 x ULN for age,
- •the creatinine clearance (or radioisotope GFR) must be >70 mL/min/1.73 m2.
- •Urine dipstick < 2+ for proteinuria. Patients who have greater than or equal to
- •2+ of proteinuria on dipstick urinalysis should undergo a 24-hour urine
- •collection; children and adolescents less than or equal to 12 years must have
- •less than or equal to 500 mg of protein/24 hours and patients > 12 years must
- •have less than or equal to 1 g of protein/24 hours.
- •No clinical evidence of nephrotic syndrome.
- •9. Adequate cardiac function (Shortening Fraction (SF) greater than or equal to 28%)
- •at screening, as determined by echocardiography; no evident and clinical
排除标准
- •1. Previous malignant tumors.
- •2. Prior systemic anti-tumor treatment.
- •3. Evidence of symptomatic spinal cord compression, CNS or brain metastases;
- •patients must undergo a MRI or CT scan of the brain and/or spine in case of
- •suspected brain metastatic disease.
- •4. Tumor invading major blood vessels (CT scan based evidence); the investigator or
- •radiologist must exclude evidence of tumor that is fully contiguous with,
- •surrounding, or extending into the lumen of a major blood vessel (e.g. pulmonary
- •artery or superior vena cava).
- •5. Major surgical procedures or anticipation of the need for major surgery (other
- •than the standard per protocol surgery) between screening and the first safety
- •follow-up visit is considered incompatible with the use of bevacizumab; minor
- •surgical procedures, including biopsy similar to and including central venous
- •access device placement, within less than 7 days prior to randomization, or
- •anticipated treatment start before the wound has healed.
- •6. Documentation of clinically evident non-healing wound (as determined by the
- •investigator), peptic ulcer or bone fracture.
- •7. Current or recent (within 30 days prior to study start) treatment with another
- •investigational drug or participation in another investigational study.
- •8. Increased risk of gastrointestinal, renal, bone marrow, or congenital bleeding
- •9. History or evidence of severe uncontrolled intercurrent illness at study entry, e.g.
- •Uncontrolled seizures.
- •Any bleeding or clotting diathesis, e.g. venous or arterial thromboembolic events
- •(VTE, ATE), pulmonary embolism (PE).
- •Any clinically significant (i.e. active) cardiovascular disease, e.g. cerebrovascular
- •accidents (CVAs)/stroke, myocardial infarction (MI), transient ischemic attack
- •(TIAs), unstable angina, or severe cardiac arrhythmia; clinical evidence of
- •arterial hypertension, specified as systolic and diastolic BP greater than or equal
- •to 95th percentile for age, gender and height (see Appendix 7).
- •Any other disease, metabolic or psychological dysfunction, physical examination
- •finding, or clinical laboratory finding giving reasonable suspicion of a disease or
- •condition that contraindicates use of an investigational drug, or places the
- •patient at unacceptable risk from treatment complications.
- •General or peripheral neuropathy greater than or equal to grade 2 which is not
- •induced by the underlying malignant disease.
- •Uncontrolled infection.
- •10. Known hypersensitivity to:
- •Any component of study drugs or ingredients.
- •Chinese hamster ovary products or other recombinant human or humanized
- •antibodies.
- •11. Ongoing (for greater than or equal to 10 days prior to the 1st dose of study
- •treatment) antithrombotic treatment, i.e. with aspirin or other platelet inhibitors,
- •anticoagulants including thrombolytic
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