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Sunitinib + Docetaxel as Second-line Treatment in Gastric Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01238055
First Posted: November 10, 2010
Last Update Posted: April 9, 2013
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.
Information provided by (Responsible Party):
Samsung Medical Center
  Purpose
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 Intervention Phase
Advanced Gastric Cancer Drug: Docetaxel + Sunitinib Drug: Docetaxel only Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

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

Secondary Outcome Measures:
  • Response rate [ Time Frame: 12 months ]
  • Overall survival [ Time Frame: 12 months ]
  • Progression free survival [ Time Frame: 12 months ]

Enrollment: 116
Study Start Date: November 2008
Study Completion Date: October 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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
Criteria

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
  Contacts and Locations
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


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

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01238055     History of Changes
Other Study ID Numbers: 2008-09-031
First Submitted: January 7, 2010
First Posted: November 10, 2010
Last Update Posted: April 9, 2013
Last Verified: January 2012

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

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Sunitinib
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