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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01238055     History of Changes
Other Study ID Numbers: 2008-09-031
Study First Received: January 7, 2010
Last Updated: April 8, 2013
Health Authority: Korea: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014