pof versus folfox plus ip paclitaxel in agc

Conditions: Gastric Cancer

Summary: the aim of this study was to compare the efficacy and safety of intravenous or intraperitoneal paclitaxel plus folfox as first-line treatment in agc with peritoneal metastases, a phase ii clinical trial.


Eligibility criteria:
inclusion criteria: * 18-75 years old; * patients must have histologically or cytologically confirmed metastatic or unresectable gastric or gastroesophageal junction (gej) adenocarcinoma. gej adenocarcinoma may be classified according to siewert's classification type i, ii, or iii * histological documentation of local recurrence or metastasis is strongly encouraged, unless the risk of such a procedure outweighs the potential benefit of confirming the metastatic disease. * if no histologic confirmation, then the metastases or recurrence will require documentation by a 2nd radiographic procedure (eg. pet/ct scan or mri in addition to the ct scan). if the imaging procedure does not confirm recurrent or metastatic disease, biopsy confirmation will be required. * patients must have ascites or peritoneal carcinomatosis confirmed by image (ct or mr or us or others) operation. * patients may have received no prior chemotherapy for metastatic or unresectable disease. patients may have received prior adjuvant therapy (chemotherapy and/or chemoradiation) if more than 6 months have elapsed between the end of adjuvant therapy and registration. * eastern cooperative oncology group performance status (ecog ps) of 0-1; * an expected survival of ≥ 3 months; * major organ function has to meet the following criteria; (1) for results of blood routine test: * hemoglobin (hb) ≥ 80g / l, * anc(absolute neutrophil count) ≥ 1.5 × 109 / l, * plt(blood platelet) ≥ 75 × 109 / l, (2) for results of biochemical tests: * blt（total bilirubin） ≤ 1.25 times the upper limit of normal (uln), * alt(alanine aminotransferase) and ast(aspartate aminotransferase ) ≤ 2.5 × ·uln, liver metastases, if any, the alt and ast≤ 5 × uln, * serum cr（creatinine）≤1uln, endogenous creatinine clearance rate \>50ml/min; * the patient has a pt（prothrombintime） (inr international normalized ratio) \< or = to 1.5 and an ptt（partial thromboplastin time）\< than or = to 3 seconds above the upper limits of normal if the patientia t is not on anticoagulation. ·if a patient is on full-dose anticoagulants, the following criteria should be met for enrollment: * the patient must have an in-range inr (usually between 2 and 3) on a stable dose of warfarin or on stable dose of lmw(low molecular weight) heparin * the patient must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. tumor involving major vessels, known varices) * pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. * men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter. * ability to understand informed consent and signing of written informed consent document prior to initiation of protocol therapy. exclusion criteria: - patients who have received previous chemotherapy for the treatment of metastatic or unresectable gastric or gej adenocarcinoma are ineligible. * patients who have received previous pre- or post-operative chemotherapy or chemoradiation are ineligible if therapy was completed less than 6 months prior to study registration. patients must have recovered from adverse events from any previous therapy. * patients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer. * patients with brain or central nervous system metastases, including leptomeningeal disease. * pregnant (positive pregnancy test) or breast feeding. * serious, non-healing wound, ulcer, or bone fracture. * significant cardiac disease as defined as: unstable angina, new york heart association (nyha) grade ii or greater, congestive heart failure, history of myocardial infarction within 6 months evidence of bleeding diathesis or coagulopathy. * history of a stroke or cva within 6 months * clinically significant peripheral vascular disease. * inability to comply with study and/or follow-up procedures. * patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial.