Irinotecan, Cisplatin, and Bevacizumab in Treating Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Adenocarcinoma of the Gastroesophageal Junction, Diffuse Adenocarcinoma of the Stomach, Intestinal Adenocarcinoma of the Stomach
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Gastroesophageal Junction
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma Metastatic or unresectable disease Siewert's classification I, II, or III No ulcerated, non-healing tumors or tumors that have developed a malignant fistula No esophageal tumors No known or active brain metastases Performance status - Karnofsky 60-100% Performance status - ECOG 0-2 Neutrophil count >= 1,500/mm^3 Platelet count >= 75,000/mm^3 No bleeding diathesis or coagulopathy Bilirubin =< 1.5 mg/dL AST and ALT =< 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) PT (INR) =< 1.5 PTT =< 3 seconds above ULN Creatinine =< 1.5 mg/dL Proteinuria < 1+ Protein < 500 mg/24-hour urine collection No acute ischemia or significant conduction abnormality by EKG No clinically significant cardiovascular disease No uncontrolled hypertension (blood pressure > 160/90 mm Hg on medication) No myocardial infarction within the past 6 months No unstable angina within the past 6 months No transient ischemic attack within the past 6 months No cerebrovascular accident within the past 6 months No other arterial thromboembolic event within the past 6 months No New York Heart Association class II-IV congestive heart failure No serious cardiac dysrhythmia requiring medication No peripheral vascular disease (grade II or greater) No history of stroke No CNS disease within the past 5 years (e.g., uncontrolled seizures) No other concurrent uncontrolled illness No ongoing or active infection requiring parental antibiotics on Day 0 of study No serious, non-healing wound No serious wound healing by secondary intention No ulcer No bone fracture No psychiatric illness or social situation that would preclude study compliance No significant traumatic injury within the past 28 days No other neoplastic disease within the past 3 years except basal cell skin cancer, carcinoma in situ of the cervix, or nonmetastatic prostate cancer No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies No other medical condition that would preclude study participation Not pregnant or nursing No nursing during and for 4 months after study participation Negative pregnancy test Fertile patients must use effective contraception during and for 4 months after study participation More than 8 weeks since prior immunotherapy and recovered No other concurrent biologic or immunologic agents No other concurrent bevacizumab No prior chemotherapy for metastatic disease No prior cisplatin or irinotecan Prior neoadjuvant and/or adjuvant chemotherapy or chemoradiotherapy allowed More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No other concurrent chemotherapy More than 3 weeks since prior radiotherapy and recovered No concurrent radiotherapy More than 28 days since prior major surgical procedure or open biopsy More than 7 days since prior fine needle aspirations or core biopsies No concurrent major surgery No other concurrent investigational agents No other concurrent anticancer therapy No concurrent chronic daily aspirin (> 325 mg/day) No concurrent nonsteroidal anti-inflammatory medications that would inhibit platelet function at doses used to treat chronic inflammatory diseases Full-dose anticoagulants allowed, provided the following criteria are met: INR in range (i.e., 2-3) while on a stable dose of warfarin or low molecular weight heparin No active bleeding or pathologic condition that would confer a high risk of bleeding (e.g., tumor involving major blood vessels or known varices) No concurrent thrombolytic agents No concurrent vitamins, antioxidants, herbal preparations, or supplements Single tablet multivitamin allowed
Sites / Locations
- Memorial Sloan-Kettering Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (bevacizumab, cisplatin, irinotecan)
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.