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Completed

NCT Number: NCT01474642

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

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.

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Key information

Conditions

Advanced or Recurrent Esophageal Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Cell Carcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capecitabine/Cisplatin(XP)

Drug

Capecitabine/Cisplatin(XP) D1-D14 Capecitabine 2000mg/m2 D#2 PO D1 Cisplatin 75mg/m2 iv q 3 weeks

Capecitabine/Paditaxel(XG)

Drug

Capecitabine/Paditaxel(XG) D1-D14 Capecitabine 2000mg/m2 D#2 PO D1,D8 Paditaxel(genexol) 80mg/m2 iv q 3 weeks

Primary outcomes

  1. response rate

    Time frame: 12 months

Secondary outcomes

  1. progression free survival

    Time frame: 12 months

  2. quality of life

    Time frame: 12 months

  3. Number of Adverse Event

    Time frame: 12 months

  4. overall survival

    Time frame: 12 months

  5. predictive marker

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2013
Study completion
2014
First posted
Nov 18, 2011
Registry last updated
Dec 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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