title: Phase I study of docetaxel, capecitabine, and carboplatin in metastatic esophagogastric cancer.
abstract: OBJECTIVE
  A phase I trial was conducted to determine the maximally tolerated dose (MTD) and dose-limiting toxicities (DLTs) of docetaxel, capecitabine, and carboplatin for first-line treatment of patients with metastatic esophageal and gastric cancers.
  
  
  METHODS
  Twenty-eight patients were treated over 5 dose levels in a 21-day cycle. Patients received carboplatin (AUC = 2) on days 1 and 8, docetaxel (35-40 mg/m2) on days 1 and 8, and capecitabine (500-2000 mg/m2) on days 1 to 10.
  
  
  RESULTS
  There were no DLTs in the first cycle of treatment. Dose reductions were required in 10 of 15 patients at the final dose level due to neutropenia, nausea, vomiting, diarrhea, dehydration, and hand/foot syndrome following a median of 3 cycles of treatment. Therefore, escalation beyond dose level 5 was not attempted. The MTD was docetaxel, 40 mg/m2 days 1 and 8; carboplatin, AUC = 2 days 1 and 8; and capecitabine, 1500 to 2000 mg/m2 days 1 to 10 in a 21-day cycle. Ten of 25 patients who could be evaluated (40%) responded and 8 of 14 patients treated at the final dose level responded (57%).
  
  
  CONCLUSIONS
  Cumulative gastrointestinal toxicities and neutropenia were the DLTs of docetaxel, capecitabine, and carboplatin. This combination represents an easily administered, active regimen for patients with metastatic gastric and esophageal cancers. Further evaluation of this regimen is indicated.
authors.affiliation: Brown University Oncology Group, Providence, Rhode Island, USA.
authors.forename: James Y
authors.initials: JY
authors.lastname: Tsai
authors.forename: David
authors.initials: D
authors.lastname: Iannitti
authors.forename: Anna
authors.initials: A
authors.lastname: Berkenblit
authors.forename: Paul
authors.initials: P
authors.lastname: Akerman
authors.forename: Ahmed
authors.initials: A
authors.lastname: Nadeem
authors.forename: Ritesh
authors.initials: R
authors.lastname: Rathore
authors.forename: David
authors.initials: D
authors.lastname: Harrington
authors.forename: Dean
authors.initials: D
authors.lastname: Roye
authors.forename: Thomas
authors.initials: T
authors.lastname: Miner
authors.forename: John M
authors.initials: JM
authors.lastname: Barnett
authors.forename: Christine
authors.initials: C
authors.lastname: Maia
authors.forename: Keith
authors.initials: K
authors.lastname: Stuart
authors.forename: Howard
authors.initials: H
authors.lastname: Safran
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D019540:Area Under Curve; D000069287:Capecitabine; D016190:Carboplatin / Q000008:administration & dosage / Q000493:pharmacokinetics; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000556:secondary*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004943:Esophagogastric Junction; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009503:Neutropenia / Q000139:chemically induced; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000069287:Capecitabine; D016190:Carboplatin; D005472:Fluorouracil