EUCTR2007-005725-29-NL进行中（未招募）不适用
A Phase III Study of ErbB2 Positive Advanced or Metastatic Gastric or Esophageal Or Gastroesophageal Junction Adenocarcinoma Treated with Capecitabine Plus Oxaliplatin with or without Lapatinib - N/A
GlaxoSmithKline Research and Development0 个研究点目标入组 410 人开始时间: 2008年8月13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
- 410
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
- All
入选标准
- •1) Signed informed consent form
- •2) Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the oesophagus or gastro-oesophageal junction (for details refer to section 4.2 of protocol)
- •3) Gastric or oesophageal cancer that is unresectable locally advanced
- •4) Radiologically evaluable disease, according to RECIST. (scans must have been completed within 28 days prior to registration.)
- •5) ErbB2 positive status assessed by local lab (IHC 3+ or FISH positive or CISH positive) from the primary or metastatic tumour.
- •Tumour tissue must be supplied from all subjects at study entry and will be sent to the central laboratory for determination of centralised ErbB2 status.
- •6) Age =18 years
- •7) ECOG Performance status = 2.
- •8) Adequate organ function assessed within 14 days prior to randomization:
- •Haematological function:
- •-Absolute neutrophil count = 1.5 x 10^9/L
- •-Heamoglobin = 9g/dL (with transfusion support if needed)
- •-Platelets = 100 x 10^9/L
- •Hepatic function:
- •-Total bilirubin = 1.5 x upper limit of normal (UNL), or 2.5 x UNL in case of documented Gilberts syndrome
- •-AST/ALT = 3 x UNL, or 5 x UNL in case of documented liver metastases
- •Renal function:
- •-Serum creatinine = 2.0 mg/dL and
- •-Calculated creatinine clearance = 50 mL/min (Cockcroft-Gault method)
- •9) Cardiac ejection fraction within institutional range of normal as measured by
- •echocardiogram (ECG) or MUGA scans where an ECG cannot be performed or is inconclusive.
- •10) Able to swallow and retain oral medications, and/or receive enteral medications via gastrectomy feeding tube, (subjects who are nothing by mouth will be deemed eligible only after review by the study medical monitor).
- •11) Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study.
- •12) Prior/Concurrent Therapy
- •-Subjects may have had prior surgery for their gastric cancer.
- •-Patients must be at least 3 weeks beyond surgery and must have recovered from any related toxicity.
- •Chemotherapy:
- •-More than 5 years since prior chemotherapy for malignancy other than gastric carcinoma
- •-Prior neoadjuvant and/or adjuvant chemotherapy for early stage disease is allowed, provided first cancer recurrence occurred more than 6 months after completion of therapy. One line of treatment in this setting is allowed.
- •Radiotherapy:
- •-At least 4 weeks since prior radiotherapy.
- •-Concurrent palliative radiotherapy for pain relief is allowed provided radiotherapy is limited to an area other than the sole site of measurable or evaluable disease
- •Biologic or hormonal therapy:
- •-More than 5 years since prior biological, hormonal or immuno- therapies for malignancy other than gastric carcinoma.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Pregnant or lactating females.
- •2) Known history of active CNS disease.
- •3) Uncontrolled ascites.
- •4) Concurrent anti-cancer therapy (chemotherapy, radiation therapy other than for pain relief, immunotherapy, biologic therapy, hormonal therapy or surgery) while taking investigational treatment.
- •5) Gastric carcinoid, epidermoid, sarcomas, or squamous cell carcinoma.
- •6) Prior palliative chemotherapy for the treatment of gastric cancer.
- •7) Prior treatment with oxaliplatin or the regimen CapeOx.
- •8) Malabsorption syndrome or uncontrolled inflammatory gastrointestinal disease (such as Crohn’s disease or ulcerative colitis).
- •9) Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure;
- •-Myocardial infarction within past 6 months
- •-New York Association Class III or IV congestive heart failure
- •10) Pre-existing grade = 2 motor or sensory neuropathy by CTC v3.0.
- •11) Uncontrolled infection.
- •12) Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical condition that would interfere with the subject's safety.
- •13) Current active hepatic or biliary disease.
- •14) History of other malignancy except:
- •-subjects who have been disease-free for 5 years
- •-subjects with a history of completely resected non-melanoma skin cancer
- •-subjects with successfully treated in situ carcinoma
- •15) Unresolved or unstable serious toxicity from prior administration of another investigational drug and/or prior cancer treatment.
- •16. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- •17. Known history of pyruvate dehydrogenase (DPD) deficiency.
- •18. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib, capecitabine, fluorouracil, platins or their excipients.
- •19. Use of any investigational drug within 30 days prior randomization.
- •20. Use of concurrent prohibited medications that would interact with study drugs, including herbal remedies and Chinese traditional medicines for cancer, and including any medications or drugs listed in table 1 of section 5.7 of the protocol.
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