PHASE II STUDY IN PATIENTS WITH LOCALLY ADVANCED GASTRIC CANCER OR GASTROESOPHAGEAL ADENOCARCINOMA TREATED WITH IRINOTECAN / CISPLATINUM INDUCTION, POTENTIALLY CURATIVE SURGERY WITH INTRAPERITONEAL ADJUSTMENT FLOXURIDINE / CISPLATINUS FOLLOWED BY CAPECITABINE.
- Conditions
- -C169 Stomach, unspecifiedStomach, unspecifiedC169
- Registration Number
- PER-012-08
- Lead Sponsor
- ew York University School of Medicina,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Patients with isolated disease My potentially resectable, for example, hepatic metastasis, omentum compromise, peritoneal implants or distal intraperitoneal lymph nodes with cancer mestastases, may be eligible based on a strictly individual evaluation.
• Both men and women> 6 = to 18 years of age with an ECOG activity status of 0-2, members of any ethnic group and minorities.
• Patients with no other invasive malignancy, with properly treated basal cells or squamous cell skin cancer, free for 5 years or more of in-situ cervical cancer or other in-situ cancer.
• Since immunity deficiency increases the risk of terminal infections when aggravated by suppressive bone marrow therapy, patients should be without active or uncontrolled infection including HIV.
• Patients without psychiatric disorders that could interfere with their consent and / or follow-up of the protocol.
• An adequate stock of bone marrow (absolute neutrophil count> or = 1500 / mmL, thrombocytes> or = 100000 / mmL, hemoglobin> or = 9 gm / dL).
• Preserved hepatic and renal function (total serum bilirubin <2 mg / dL, SGOT / SGPT or = 50 mL / min) are required. The creatinine clearance must be normalized for a BSA of 1.73 M2. The prothrombin time, partially activated thromboplastin time, and thrombin time should be within the range of normal values.
• Since the chemotherapeutic agents to be used are known or suspected of being teratogenic or with other adverse effects, women should not be pregnant or lactating. All women with reproductive potential should have a blood test or urine study within 2 weeks before registration to rule out pregnancy. All patients of reproductive age can not participate unless they agree to use an effective medically acceptable method of contraception.
• Patients without diagnosis of Gilbert´s disease and a bilirubin level> or = 2.0 mg / dL, given that these patients may have excessive toxicity to CPT-11.
• No severe reaction prior to fluoropyrimidine therapy or known hypersensitivity to 5-FU, Capecitabine (Xeloda) is contraindicated in patients with acute renal impairment, ie, creatinine clearance below 30 mL / min, determined by the Cockroñ- Gault as shown in section 5.5.5 (i). In patients with moderate renal impairment (creatinine clearance 30-50 mL / min), which develops during the course of adjuvant treatment with Capecitabine, the dose is reduced to 75% of the initial dose.
• Patients should not have any severe concurrent disease, such as cardiac condition that does not respond to medication, myocardial infarction within the last 12 months, active infection or uncontrolled lung disease, or any other disease that the investigator believes would make the patient inappropriate for entry into this study.
• Patients who sign the informed consent as specified in section 4. Registration procedures.
• Patients who fail (i) systemic induction therapy for PD, or (ii) potentially curative surgery, or (iii) IP / systemic adjuvant therapy for disease recurrence, are excluded from additional protocol treatment (see 7. Evaluation during the treatment, and 8. Post-Treatment Evaluation). Patients who leave the protocol can undergo surgery if the tumor is locally resectable, and can be treated with a 5-FU-based regimen or other appropriate treatment.
• The development of complications in the course of treatment of the protocol secondary to the tumor, surgery or therapy, which require surgical intervention such as gastro-intestinal obstruction, bleeding, perforation, or complications that prevent IP or systemic chemotherapy.
• Unacceptable toxicity that does not respond to dose modification and / or recommended medication.
• Intercurrent diseases not related to cancer that prevent continuation of therapy or regular follow-up of the patient, as well as other changes in the patient´s condition that, in the opinion of the PI, make subsequent treatment unacceptable.
• Withdrawal of patient´s consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method