Sunitinib + Docetaxel as Second-line Treatment in Gastric Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01238055
First received: January 7, 2010
Last updated: April 8, 2013
Last verified: January 2012

January 7, 2010
April 8, 2013
November 2008
April 2012   (final data collection date for primary outcome measure)
time to progression [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01238055 on ClinicalTrials.gov Archive Site
  • Response rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Progression free survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01238055
2008-09-031
No
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