Phase II Trial of XP Versus XG in Advanced Esophageal Squamous Cell Carcinoma
Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
Participant gender:
Summary
Until today, the 5-FU/cisplatin combination is the reference regimen with 30-45% response
rates, which is most commonly used to treat patients with metastatic, recurrent or locally
advanced, unresectable squamous cell carcinoma of the esophagus. Because the classical dose
schedule of this two-drug combination is cisplatin 100 mg/m2 day 1 and 5-FU 1000 mg/m2/day
continuous infusion for 96-120 hr, prolonged administration time and mucosal toxicity are
inconvenient to the patients with the aim of palliation. Capecitabine, which is oral prodrug
of 5-FU and mimic continuously-infused 5-FU, is being investigated in phase I, II and III
trials for the treatment of gastric, gastroesophageal, and esophageal cancers, primarily in
the first-line metastatic setting but also in the adjuvant setting. In the investigators
experience, capecitabine plus cisplatin combination (XP) as a first-line treatment for 45
patients with advanced or recurrent esophageal squamous cell carcinoma demonstrated a
promising anti-tumor activity with 57% of response rate and showed tolerable toxicity with
convenience.
Paclitaxel has been also investigated as monotherapy and in combination with cisplatin in
patients with advanced esophageal cancer. A Dutch phase II study demonstrated that paclitaxel
combination with carboplatin had shown an encouraging confirmed response rate of 59% with 51
patients with resectable esophageal cancer in neoadjuvant setting. Another Dutch phase II
study showed 43% of response rate including 4% of CR with 8 months of response duration when
paclitaxel plus cisplatin administration was given for patients with metastatic esophageal
cancer. Although recently first-line palliative chemotherapy regimen in esophageal cancer has
been investigated, many trials have failed to show superiority to 5-FU/cisplatin combination.
Since the investigators considered that XP or XG (genexol) is more effective and convenient
chemotherapy regimen than 5-FU/cisplatin, this randomized phase II study was planned to
compare XP with XG in terms of efficacy and tolerability.