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Sunitinib + Docetaxel as Second-line Treatment in Gastric Cancer

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ClinicalTrials.gov Identifier: NCT01238055
Recruitment Status : Completed
First Posted : November 10, 2010
Last Update Posted : April 9, 2013
Information provided by (Responsible Party):
Samsung Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Gastric Cancer Drug: Docetaxel + Sunitinib Drug: Docetaxel only Phase 2

Detailed Description:
This is a randomized phase II trial of Sunitinib and Docetaxel in advanced gastric cancer patients who had prior chemotherapy with Fluoropyrimidine and Platinum.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Sunitinib and Docetaxel in Advanced Gastric Cancer Patients Who Had Prior Chemotherapy With Fluoropyrimidine and Platinum
Study Start Date : November 2008
Primary Completion Date : April 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Docetaxel + Sunitinib
Docetaxel and Sunitinib
Drug: Docetaxel + Sunitinib

Docetaxel 60 mg/m2 iv, every 3 weeks

Sunitinib 37.5 mg qd daily, every 3 weeks

Active Comparator: Docetaxel
Docetaxel only
Drug: Docetaxel only
Docetaxel 60 mg/m2 iv

Primary Outcome Measures :
  1. time to progression [ Time Frame: every 6 weeks ]

Secondary Outcome Measures :
  1. Response rate [ Time Frame: 12 months ]
  2. Overall survival [ Time Frame: 12 months ]
  3. Progression free survival [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01238055

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Principal Investigator: Jeeyun Lee, M.D., Ph.D. Samsung Medical Center, Seoul, Korea

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01238055     History of Changes
Other Study ID Numbers: 2008-09-031
First Posted: November 10, 2010    Key Record Dates
Last Update Posted: April 9, 2013
Last Verified: January 2012

Keywords provided by Samsung Medical Center:
advanced gastric cancer
fluoropyrimidine platinum based chemotherapy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors