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临床试验/NL-OMON33786
NL-OMON33786已完成2 期

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 - IMP 12007

Bayer0 个研究点目标入组 20 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
2 期
状态
已完成
发起方
Bayer
入组人数
20
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99（—）

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/ul
  • •- Platelet count >= 75,000/ul
  • •. Total bilirubin <= 1.5 times the upper limit of normal
  • 另有 3 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 treat

研究者

发起方
Bayer

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