Sunitinib + Docetaxel as Second-line Treatment in Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01238055
Recruitment Status : Completed
First Posted : November 10, 2010
Last Update Posted : April 9, 2013
Information provided by (Responsible Party):
Samsung Medical Center

January 7, 2010
November 10, 2010
April 9, 2013
November 2008
April 2012   (Final data collection date for primary outcome measure)
time to progression [ Time Frame: every 6 weeks ]
Same as current
Complete list of historical versions of study NCT01238055 on Archive Site
  • Response rate [ Time Frame: 12 months ]
  • Overall survival [ Time Frame: 12 months ]
  • Progression free survival [ Time Frame: 12 months ]
Same as current
Not Provided
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Sunitinib + Docetaxel as Second-line Treatment in Gastric Cancer
Randomized Phase II Trial of Sunitinib and Docetaxel in Advanced Gastric Cancer Patients Who Had Prior Chemotherapy With Fluoropyrimidine and Platinum
The purpose of this study is to determine whether Sunitinib and Docetaxel is effective in the treatment of advanced gastric cancer patients who had prior chemotherapy with fluoropyrimidine and platinum.
This is a randomized phase II trial of Sunitinib and Docetaxel in advanced gastric cancer patients who had prior chemotherapy with Fluoropyrimidine and Platinum.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Gastric Cancer
  • Drug: Docetaxel + Sunitinib

    Docetaxel 60 mg/m2 iv, every 3 weeks

    Sunitinib 37.5 mg qd daily, every 3 weeks

  • Drug: Docetaxel only
    Docetaxel 60 mg/m2 iv
  • Experimental: Docetaxel + Sunitinib
    Docetaxel and Sunitinib
    Intervention: Drug: Docetaxel + Sunitinib
  • Active Comparator: Docetaxel
    Docetaxel only
    Intervention: Drug: Docetaxel only
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2012
April 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenoca (i.e. an adenocarcinoma with > 50% extension in the stomach)
  2. patients must present with stage IV disease not amenable to surgery, radiation or combined modality therapy with curative intent. Patients previously undergoing local treatment (surgery and/or radiation) must have subsequently progressed or recurred
  3. prior chemotherapy wit fluoropyrimidine and platinum
  4. measurable or evaluable disease according to RECIST
  5. age, 18 years or older
  6. ECOG performance status 0 - 2
  7. adequate organ function as defined by the following criteria absolute neutrophil count (ANC) ≥ 1,500/ul platelets ≥ 100,000/ul AST/ALT ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver involvement Total serum bilirubin ≤ 2.0 mg/dL
  8. life expectancy of ≥ 3 months
  9. signed written informed consent

Exclusion Criteria:

  1. more than one prior chemotherapy for metastatic disease
  2. severe co-morbid illness and/or active infections
  3. NCI CTCAE Grade 3 hemorrhage from any cause < 4 weeks before enrollment
  4. preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart
  5. pregnant or lactating women
  6. active CNS metastases not controllable with radiotherapy or corticosteroids
  7. active and uncontrollable bleeding from gastrointestinal tract
  8. known history of hypersensitivity to study drugs
  9. prior treatment with sunitinib
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
Not Provided
Not Provided
Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Jeeyun Lee, M.D., Ph.D. Samsung Medical Center, Seoul, Korea
Samsung Medical Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP