Efficacy Comparison Study of Combination Regimens to Treat Advanced Esophageal Squamous Cell Carcinoma (XP versus XT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00816634
First received: December 30, 2008
Last updated: September 6, 2011
Last verified: September 2011
  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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Response rates of both regimens [ Time Frame: December 2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  1. Histologically confirmed metastatic, or recurrent esophageal squamous cell carcinoma
  2. Age > 18 years
  3. ECOG performance status 0 - 2
  4. At least one measurable lesion(s) by RECIST criteria
  5. Life expectancy ≥ 3 months
  6. Patients may have received prior adjuvant chemotherapy with 5-FU with cisplatin as long as it has been 12 months since completion of regimen.
  7. No previous palliative chemotherapy
  8. Prior radiotherapy must be completed 4 weeks before study entry.
  9. Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
  10. Adequate renal function (≤ serum creatinine 1.5 mg/dl or CCr ≥ 50 ml/min)
  11. Adequate liver function (≤ serum bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 upper normal limit)
  12. Written informed consent

Exclusion Criteria:

  1. Other tumor types such as adenocarcinoma, small cell carcinoma
  2. Evidence of CNS metastasis
  3. Contraindication to any drug contained in the chemotherapy regimen
  4. Previous adjuvant treatment with 5-FU, cisplatin, capecitabine or paclitaxel finished less than 1 year
  5. Evidence of serious gastrointestinal bleeding
  6. History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
  7. 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.
  8. Serious pulmonary conditions/illness (e.g. chronic lung disease with hypoxemia)
  9. Serious metabolic disease such as severe non-compensated diabetes mellitus
  10. History of significant neurologic or psychiatric disorders
  11. Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
  12. Positive serology for the HIV
  13. Pregnant or lactating women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816634

Contacts
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

Locations
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         
Sponsors and Collaborators
Samsung Medical Center
  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 Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Capecitabine
Cisplatin
Fluorouracil
Paclitaxel
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 21, 2014