Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Samsung Medical Center |
---|---|
Information provided by: | Samsung Medical Center |
ClinicalTrials.gov Identifier: | NCT00816634 |
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. In our 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 we considered that XP or XT is more effective and convenient chemotherapy regimen than 5-FU/cisplatin, this randomized phase II study was planned to compare XP with XT in terms of efficacy and tolerability.
Condition | Intervention | Phase |
---|---|---|
First Line Chemotherapy Capecitabine Plus Cisplatin Versus Capecitabine Plus Paclitaxel Advanced or Recurrent Esophageal Squamous Cell Carcinoma |
Drug: Capecitabine plus cisplatin(XP) versus capecitabine plus paclitaxel(XT) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Phase II Trial of Capecitabine Plus Cisplatin (XP) Versus Capecitabine Plus Paclitaxel (XT) as a First-Line Treatment for Advanced or Recurrent Esophageal Squamous Cell Carcinoma |
Estimated Enrollment: | 94 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Chemotherapy regimen (XP): D1- D14 Capecitabine 1000 mg/m2 bid p.o. D1 Cisplatin 75 mg/m2 + NS 150mL MIV over 1hr repeat every 3 weeks |
Drug: Capecitabine plus cisplatin(XP) versus capecitabine plus paclitaxel(XT)
3.2 Overview of Study Design This study is a prospective, randomized, phase II study comparing response rate between patients with XP chemotherapy versus XG chemotherapy for patients with metastatic squamous cell carcinoma. Chemotherapy regimen (XP): D1- D14 Capecitabine 1000 mg/m2 bid p.o. D1 Cisplatin 75 mg/m2 + NS 150mL MIV over 1hr every 3 weeks Chemotherapy regimen (XT): D1- D14 Capecitabine 1000 mg/m2 bid p.o. D1, D8 Genexol (Paclitaxel) 80 mg/m2 + D5W 500mL MIV over 3hrs every 3 weeks |
2: Active Comparator
XT Regimen: D1- D14 Capecitabine 1000 mg/m2 bid p.o. D1, D8 Genexol (Paclitaxel) 80 mg/m2 + D5W 500mL MIV over 3hrs Repeat every 3 weeks |
Drug: Capecitabine plus cisplatin(XP) versus capecitabine plus paclitaxel(XT)
3.2 Overview of Study Design This study is a prospective, randomized, phase II study comparing response rate between patients with XP chemotherapy versus XG chemotherapy for patients with metastatic squamous cell carcinoma. Chemotherapy regimen (XP): D1- D14 Capecitabine 1000 mg/m2 bid p.o. D1 Cisplatin 75 mg/m2 + NS 150mL MIV over 1hr every 3 weeks Chemotherapy regimen (XT): D1- D14 Capecitabine 1000 mg/m2 bid p.o. D1, D8 Genexol (Paclitaxel) 80 mg/m2 + D5W 500mL MIV over 3hrs every 3 weeks |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Young-Hyuck Im, MD, PhD | 82-2-3410-3445 | imyh00@skku.edu |
Contact: Yeon-Hee Park, MD, PhD | 82-2-3410-1780 | yhparkhmo@skku.edu |
Korea, Republic of | |
Samsung Medical Center | Recruiting |
Seoul, Korea, Republic of, 135-710 | |
Contact: Young-Hyuck Im, MD, PhD 82-2-3410-3445 imyh00@skku.edu | |
Principal Investigator: Young-Hyuck Im, MD, PhD | |
Sub-Investigator: Yeon-Hee Park, MD, PhD |
Responsible Party: | Samsung Medical Center ( Young-Hyuck Im, Associate Professor ) |
Study ID Numbers: | IRB 2008-07-059 |
Study First Received: | December 30, 2008 |
Last Updated: | December 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00816634 History of Changes |
Health Authority: | South Korea: Institutional Review Board |
First line chemotherapy Advanced or recurrent esophageal squamous cell carcinoma |
Antimetabolites Capecitabine Gastrointestinal Diseases Antimitotic Agents Squamous Cell Carcinoma Recurrence Carcinoma Digestive System Diseases Radiation-Sensitizing Agents Cisplatin |
Esophageal Disorder Paclitaxel Tubulin Modulators Epidermoid Carcinoma Esophageal Diseases Neoplasms, Squamous Cell Carcinoma, Squamous Cell Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
Antimetabolites Disease Attributes Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Physiological Effects of Drugs Pathologic Processes Cisplatin Therapeutic Uses Neoplasms, Squamous Cell Capecitabine Neoplasms by Histologic Type Mitosis Modulators |
Antimitotic Agents Recurrence Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Paclitaxel Tubulin Modulators Esophageal Diseases Carcinoma, Squamous Cell Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |