As such, we investigated the efficacy and tolerability of gefitinib in combination with celecoxib in patients with advanced or refractory GI tumors of epithelial origin. Methods Patient population The study population consisted of adults (aged ≥18 years) with advanced or refractory, stage III/IV, histologically or click here cytologically confirmed GI tumors of epithelial origin

(i.e., esophageal, gall bladder, colorectal, Inhibitors,research,lifescience,medical or pancreatic). Refractory patients had received previous treatment including ≥1 chemotherapeutic regimen with or without previous radiotherapy. However, patients with untreated advanced disease could participate if they were considered unsuitable Inhibitors,research,lifescience,medical for, or if they had refused, conventional chemotherapy. Patients with ≥1 measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST), an Eastern Cooperative Oncology Group (ECOG) performance status of ≤3, and

a life expectancy of >12 weeks were eligible. Patients were ineligible to participate in the study in the event of: any evidence of severe or uncontrolled systemic disease (e.g., unstable Inhibitors,research,lifescience,medical or uncompensated respiratory, cardiac, hepatic, or renal disease); active duodenal or gastric ulcers; any other co-existing malignancy or malignancy diagnosed within the past two years (with the exception of basal cell carcinoma or cervical cancer in situ); unresolved chronic toxicity greater than Common Toxicity Criteria (CTC) grade 2 from prior therapies (except alopecia); evidence of incomplete Inhibitors,research,lifescience,medical healing from previous oncologic or other surgery, or any known hematologic bleeding dyscrasias; any contraindication to the use of celecoxib; pregnancy or breastfeeding.

In addition, patients undergoing concomitant treatment with phenytoin, carbamazepine, Inhibitors,research,lifescience,medical barbiturates, rifampicin, or St John’s Wort were not eligible to participate. Furthermore, except for the study drugs, use of systemic treatments known to have an effect on GI tumors was not permitted during the trial. Radiotherapy, however, could be used outside the measurable lesions if necessary for symptomatic or healing purposes. Patients were also excluded if any of the following laboratory parameters were recorded during screening: absolute neutrophil count <1.0×109/L; platelets <100×109/L; hemoglobin <9.0 g/dL; serum bilirubin >1.25 times the upper limit either of normal (ULN); serum creatinine >1.8 mg/dL or creatinine clearance <60 mL/min; alanine aminotransferase or aspartate aminotransferase >2.5 times the ULN if no demonstrable liver disease, or >5.0 times the ULN in the presence of liver metastases. Study design This AstraZeneca-sponsored study (1839IL/0086) was a pilot, open-label, non-comparative, phase I/II study conducted at several centers in Brazil.