EUCTR2008-004429-41-NL进行中（未招募）不适用
A Double-Blind, Randomized Phase II Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer Patients who have achieved a Complete Clinical Response after Standard Platinum/Taxane Containing Chemotherapy
Bayer Healthcare AG, D-51368 Leverkusen, Germany0 个研究点目标入组 250 人开始时间: 2008年11月12日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
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
- 性别
- Female
入选标准
- •Patients must be able and willing to sign a written informed consent. A signed
- •informed consent must be appropriately obtained prior to any study specific
- •procedures.
- •· Age > 18 years.
- •· Histologically confirmed FIGO stage (57) III or IV ovarian epithelial cancer or
- •primary peritoneal cancer at presentation. Patients must have achieved a clinical
- •complete response (disappearance of all clinical and radiological evidence of
- •tumor) after only one regimen (4-8 cycles) of platinum and taxane-containing
- •standard chemotherapy received after tumor debulkment. Details for chemotherapy
- •and surgical debulkment are as follows:
- •- Standard debulking surgery: Surgery followed by one regimen (4-8 cycles)
- •of platinum and taxane-containing standard chemotherapy received after
- •tumor debulkment.
- •- Interval surgical debulkment: Interval debulking will be defined as
- •debulking surgery that is performed after a minimum of 2 cycles of
- •platinum/taxane containing chemotherapy, or after a maximum of 6 cycles
- •of chemotherapy. All patients who undergo interval debulking must
- •subsequently complete at least 2 additional cycles of chemotherapy after
- •debulking, and all must complete the required 4-8 cycles of chemotherapy.
- •- There is to be only one debulking procedure per patient.
- •- The taxane and platinum compounds used for either intravenous or
- •intraperitoneal treatment can be replaced with another taxane or platinum
- •compound, respectively. Dosing and timing of the treatment cycles (e.g. 3-
- •weekly or 4 weekly) may vary at the discretion of the clinical investigator.
- •- Intraperitoneal chemotherapy is not allowed for patients undergoing
- •interval debulking. For patients with optimally debulked residual disease
- •following standard debulking surgery (largest tumor nodule = 1.0 cm),
- •intraperitoneal chemotherapy can be applied.
- •- No more than 6 intraperitoneal treatment cycles are allowed.
- •- Cross-over from intraperitoneal chemotherapy to standard intravenous
- •taxane/platinum chemotherapy is allowed at any time. However, the total
- •number of treatment cycles, no matter what modality, must not exceed 8.
- •- Complete clinical response will be documented via an eligibility scan that is
- •performed after completion of required chemotherapy. No previous
- •chemotherapy can be administered except for the one regimen of IV/IP
- •chemotherapy for ovarian or primary peritoneal cancer.
- •· Normal serum CA125 level within 14 days prior to first dose of the study drug.
- •· Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •· All scans used to document complete response must be done within 42 days prior
- •to randomization.
- •· Eligibility scan must be completed within 60 days of the date of the last dose of
- •chemotherapy.
- •· Patients must be able to swallow and retain oral medication.
- •· Life expectancy of at least 12 weeks.
- •· Adequate bone marrow, liver and renal function as assessed by the following
- •laboratory requirements to be conducted within 14 days prior to randomization:
- •. Hemoglobin > 8.5 g/dl
- •- Absolute neutrophil count (ANC) >1,500/micro liter
- •- Platelet count ³ 75,000/ml
- •. Total bilirubin < 1.5 times the upper limit of normal
- 另有 7 项未显示
排除标准
- •Patients with any residual cancer tissue after the completion of chemotherapy
- •detectable by standard CT or magnetic resonance imaging (MRI).
- •· Prior local radiotherapy, neoadjuvant chemotherapy or hormonal or any other
- •systemic treatment other than that specified in the protocol for any current or prior
- •diagnosis of ovarian or primary peritoneal cancer. Single-agent weekly paclitaxel
- •will not be considered standard for the purpose of this trial, and is therefore
- •· Male sex.
- •· Patients with more than one surgical procedure for ovarian or peritoneal cancer.
- •This does not refer to diagnostic biopsies, but does exclude second-look operations.
- •· Histologic subtypes of ovarian cancer other than epithelial (i.e. sarcoma,
- •lymphoma, germ cell).
- •· Major surgery, open biopsy, or significant traumatic injury within 30 days prior to
- •randomization.
- •· Non-healing wound, ulcer, or bone fracture.
- •· Evidence or history of bleeding diathesis or coagulopathy.
- •· Clinically significant cardiac disease including congestive heart failure > class II
- •New York Heart Association (NYHA) (see Appendix 10.6), unstable angina
- •(angina symptoms at rest), new-onset angina (begun within the last 3 months) or
- •myocardial infarction within the past 6 months prior to randomization.
- •· Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy or uncontrolled
- •hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 90
- •mmHg) despite optimal medical management.
- •· Thrombotic or embolic venous or arterial events, such as a cerebrovascular
- •accident, including transient ischemic attacks and pulmonary embolism within the
- •past 6 months.
- •· Hemorrhage/bleeding event ³ NCI-Common Terminology Criteria for Adverse
- •Events (CTCAE) Grade 3 within 30 days of randomization.
- •· Infection > NCI-CTCAE Grade 2.
- •· Known human immunodeficiency virus infection or infection with hepatitis B or C.
- •· Previous or concurrent cancer that is distinct in primary site or histology from
- •ovarian or primary peritoneal cancer within 5 years prior to randomization
- •EXCEPT cervical cancer in situ, treated basal cell carcinoma and superficial
- •bladder tumors [Ta (Non invasive tumor), Tis (Carcinoma in situ) and T1 (Tumor
- •invades lamina propria)].
- •· Known or suspected allergy to sorafenib or hypersensitivity to sorafenib or any
- •agent given in the course of this trial.
- •· Patients with seizure disorder requiring medication (such as steroids or antiepileptics).
- •· Patients undergoing renal dialysis.
- •· Substance abuse, medical, psychological or social conditions that may interfere
- •with the patient’s participation in the study or evaluation of the study results.
- •· Unresolved toxicity (i.e. neurotoxicity) attributed to the required chemotherapy
- •higher than NCI-CTCAE (version 3) Grade 2 (excluding cases of alopecia).
- •· Patients unable to swallow oral medications.
- •· Any malabsorption condition.
- •· Any condition that is unstable or could jeopardize the safety of the patient and their
- •compliance in the study.
- •· Known brain metastasis. Patients with unexplained neurological symptoms will
- •undergo a CT scan/MRI of the brain to exclude brain metastasis.
- •· Pregnant or breast-feeding patients. Women of childbearing potential must have a
- •negative pregnancy test performed within 14 days of the start of treatment, and
- 另有 3 项未显示
研究者
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