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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Advanced or Recurrent Esophageal Squamous Cell Carcinoma

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Jeeyun Lee, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center, Seoul, Korea

Authority:

Korea: Food and Drug Administration

Study ID:

2011-09-10

NCT ID:

NCT01474642

Start Date:

September 2008

Completion Date:

September 2012

Related Keywords:

  • Advanced or Recurrent Esophageal Squamous Cell Carcinoma
  • Advanced or recurrent esophageal squamous cell carcinoma
  • Randomizes phase II trial
  • Capecitabine
  • Cisplatin
  • Genexol
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases

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