CTRI/2009/091/000498已完成3 期
EGF110656 : A Phase III Study for ErbB2 Positive Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Adenocarcinoma Treated With Capecitabine Plus Oxaliplatin With or Without Lapatinib
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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
入排标准
入选标准
- •Inclusion Criteria
- •Subjects eligible for enrolment in the study must meet all of the following criteria:
- •1.Signed informed consent; willing and able to complete all required components of study.
- •2.Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the esophagus or gastro-esophageal junction.
- •Pathologic confirmation may be made from the metastatic site. Biopsy of the primary tumor is not necessary. Patients with pathologic confirmation from a metastatic site along with clinical/radiological documentation of gastric involvement and no evidence of another primary tumor are also eligible.
- •Allowable histological subtypes include adenocarcinoma NOS, papillary carcinoma, adenocarcinoma, interstitial type, clear cell adenocarcinoma, mucinous carcinoma, signet ring cell carcinoma, undifferentiated carcinoma, carcinoma NOS.
- •3.Gastric cancer that is unresectable due to locally advanced (defined as stage IV: T4N1-3 or TanyN3), metastatic, or locally recurrent disease; Esophageal cancer that is unresectable due to locally advanced (T3N1 or T4Nany), metastatic or locally recurrent disease.
- •4.Measurable or non-measurable, but radiologically evaluable disease, according to RECIST [Therasse, 2000]. X-rays, scans, or physical exams for either measurable or non-measurable disease must have been completed within 28 days prior to registration.
- •5.ErbB2 amplification by FISH assessed by the local or designated central laboratory; Subjects with unknown ErbB2 status are not eligible.
- •Limited IHC (IHC3+), CISH amplification, or SISH amplification is permitted.
- •Tumor tissue must be supplied from all subjects at study entry and will be sent to the designated central laboratory for determination of centralized ErbB2 status. Tumor biopsies may be from either the primary or metastatic site of disease.
- •6.Age equal to or not less than 18 years
- •7.ECOG Performance status equal to or not less than 2.
- •8.Adequate organ function assessed within 14 days prior randomization:
- •Hematological function:
- •ANC equal to or not more than 1.5 x 109/L
- •Hemoglobin equal to or not more than 9g/dL (with transfusion support if needed)
- •Platelets equal to or not more than 100 x 109/L
- •Hepatic function:
- •Total bilirubin equal to or not less than 1.5 x UNL (or 2.5 x UNL in case of documented Gilberts syndrome)
- •AST/ALT equal to or not less than 3 x UNL (or 5 x UNL in case of documented liver metastases)
- •Renal function:
- •Serum creatinine equal to or not less than 2.0 mg/dL and
- •Calculated creatinine clearance equal to or not more than 50 mL/min (Cockcroft-Gault method)
- •If serum creatinine is within institutional normal limits and calculated creatinine clearance is less than 50 mL/min; a 24-hour urine creatinine clearance that is within institutional ranges of normal may be substituted
- •9.Cardiac ejection fraction within institutional range of normal as measured by echocardiogram (ECHO). Multi-gated acquisition (MUGA) scans will be accepted in cases where an ECHO 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 NPO will be deemed eligible only after review by the study medical monitor).
- •11.Women and men with potential to have children must be wi
排除标准
- •Exclusion Criteria:
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •1.Pregnant or lactating females at anytime during the study.
- •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-based neoadjuvant or adjuvant chemotherapy completed less than 12 months.
- •8.Malabsorption syndrome or uncontrolled inflammatory gastrointestinal disease (such as Crohnâ??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 more than or equal to 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 subjects safety.
- •13.Subjects who have current active hepatic or biliary disease (with exception of patients with Gilberts syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- •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 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.
- •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 the protocol.
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