Efficacy Comparison Study of Combination Regimens to Treat Advanced Esophageal Squamous Cell Carcinoma (XP versus XT)
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Purpose
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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Response rates of both regimens [ Time Frame: December 2010 ] [ Designated as safety issue: Yes ]
- a) progression-free survival b) quality of life c) toxicity d) overall survival e) predictive markers [ Time Frame: December 2010 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 94 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
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 |
|
Active Comparator: 2
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 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed metastatic, or recurrent esophageal squamous cell carcinoma
- Age > 18 years
- ECOG performance status 0 - 2
- At least one measurable lesion(s) by RECIST criteria
- Life expectancy ≥ 3 months
- Patients may have received prior adjuvant chemotherapy with 5-FU with cisplatin as long as it has been 12 months since completion of regimen.
- No previous palliative chemotherapy
- Prior radiotherapy must be completed 4 weeks before study entry.
- Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
- Adequate renal function (≤ serum creatinine 1.5 mg/dl or CCr ≥ 50 ml/min)
- Adequate liver function (≤ serum bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 upper normal limit)
- Written informed consent
Exclusion Criteria:
- Other tumor types such as adenocarcinoma, small cell carcinoma
- Evidence of CNS metastasis
- Contraindication to any drug contained in the chemotherapy regimen
- Previous adjuvant treatment with 5-FU, cisplatin, capecitabine or paclitaxel finished less than 1 year
- Evidence of serious gastrointestinal bleeding
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
- Clinically significant cardiac disease (e.g. severe non-compensated hypertension, non-compensated heart failure, dilated cardiomyopathy, and coronary heart disease with ST segment depression in ECG) or myocardial infarction within the last 6 months.
- Serious pulmonary conditions/illness (e.g. chronic lung disease with hypoxemia)
- Serious metabolic disease such as severe non-compensated diabetes mellitus
- History of significant neurologic or psychiatric disorders
- Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
- Positive serology for the HIV
- Pregnant or lactating women
Contacts and Locations| 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 | |
More Information
No publications provided
| Responsible Party: | Young-Hyuck Im, Associate Professor, Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT00816634 History of Changes |
| Other Study ID Numbers: | 2008-07-059 |
| Study First Received: | December 30, 2008 |
| Last Updated: | September 6, 2011 |
| Health Authority: | South Korea: Institutional Review Board |
Keywords provided by Samsung Medical Center:
|
First line chemotherapy Advanced or recurrent esophageal squamous cell carcinoma |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Esophageal Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Gastrointestinal Diseases Digestive System Diseases Capecitabine Cisplatin Paclitaxel Fluorouracil Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Antimetabolites, Antineoplastic Antimetabolites Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 19, 2013