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Phase II Trial of XP Versus XG in Advanced Esophageal Squamous Cell Carcinoma

This study is currently recruiting participants.
Verified November 2011 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Jeeyun Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01474642
First received: November 10, 2011
Last updated: November 15, 2011
Last verified: November 2011
History of Changes
  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 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.


Condition Intervention Phase
Advanced or Recurrent Esophageal Squamous Cell Carcinoma
 Drug: Capecitabine/Cisplatin(XP)
Drug: Capecitabine/Paditaxel(XG)
 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 Genexol (XG) as a First-line Treatment for Advanced or Recurrent Esophageal Squamous Cell Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • response rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • progression free survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • quality of life [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Number of Adverse Event [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • overall survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • predictive marker [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 94
Study Start Date: September 2008
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Capecitabine/Cisplatin(XP)
Capecitabine AND Cisplatin
 Drug: Capecitabine/Cisplatin(XP)
Capecitabine/Cisplatin(XP) D1-D14 Capecitabine 2000mg/m2 D#2 PO D1 Cisplatin 75mg/m2 iv q 3 weeks
Active Comparator: Capecitabine/Paditaxel(XG)
Capecitabine + Paditaxel(genexol)
 Drug: Capecitabine/Paditaxel(XG)
Capecitabine/Paditaxel(XG) D1-D14 Capecitabine 2000mg/m2 D#2 PO D1,D8 Paditaxel(genexol) 80mg/m2 iv q 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • No prior palliative chemotherapy
  • Patients may have received prior adjuvant chemotherapy with 5-FU with cisplatin as long as it has been 6months since completion of regimen.
  • Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hb 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 UNL)
  • Written informed consent

Exclusion Criteria:

  • Other tumor type than squamous cell carcinoma
  • CNS metastasis
  • Contraindication to any drug contained in the chemotherapy regimen
  • Previous adjuvant treatment with 5-FU, cisplstin, capecitabine or paclitaxel finished less than 1 year6 months
  • 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
  • Serious pulmonary conditions/illness
  • 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
  • Pregnancy, breast feeding patient
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474642

Contacts
Contact: Jeeyun Lee, M.D., Ph.D 822-3410-3459 jyun.lee@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Principal Investigator: Jeeyun Lee, M.D., Ph.D.            
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Jeeyun Lee, M.D., Ph.D. Samsung Medical Center, Seoul, Korea
  More Information

No publications provided

Responsible Party: Jeeyun Lee, Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01474642     History of Changes
Other Study ID Numbers: 2011-09-10
Study First Received: November 10, 2011
Last Updated: November 15, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
Advanced or recurrent esophageal squamous cell carcinoma
Randomizes phase II trial
Capecitabine
Cisplatin
Genexol

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
 Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 23, 2013