A Multicenter, Open-Label, Phase II Study of Irinotecan, Cisplatin, and Bevacizumab in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Date de début de l'étude : 1 avril 2004

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