Know Cancer

or
forgot password

Phase II Study of Docetaxel and Gemcitabine in Previously Treated Metastatic Esophageal Squamous Cell Cancer


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

Thank you

Trial Information

Phase II Study of Docetaxel and Gemcitabine in Previously Treated Metastatic Esophageal Squamous Cell Cancer


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 1.1 criteria

- Life expectancy ≥ 3 months

- At least one cytotoxic chemotherapy regimen (adjuvant chemotherapy will be considered
as one regimen if administered within 6 months from the date of study entry) (upto
three prior regimens will be allowed)

- Prior radiotherapy must be completed 2 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:

- Evidence of serious gastrointestinal bleeding

- 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

- Pregnant or lactating woman

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

1years

Safety Issue:

No

Authority:

Korea: Food and Drug Administration

Study ID:

2011-03-053

NCT ID:

NCT01469598

Start Date:

August 2011

Completion Date:

Related Keywords:

  • Metastatic Carcinoma
  • Recurrent Esophageal Squamous Cell Carcinoma
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Esophageal Diseases

Name

Location