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
1 other identifier
interventional
116
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2008
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 7, 2010
CompletedFirst Posted
Study publicly available on registry
November 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedApril 9, 2013
January 1, 2012
3.4 years
January 7, 2010
April 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time to progression
every 6 weeks
Secondary Outcomes (3)
Response rate
12 months
Overall survival
12 months
Progression free survival
12 months
Study Arms (2)
Docetaxel + Sunitinib
EXPERIMENTALDocetaxel and Sunitinib
Docetaxel
ACTIVE COMPARATORDocetaxel only
Interventions
Docetaxel 60 mg/m2 iv, every 3 weeks Sunitinib 37.5 mg qd daily, every 3 weeks
Eligibility Criteria
You may qualify if:
- histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenoca (i.e. an adenocarcinoma with \> 50% extension in the stomach)
- 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
- prior chemotherapy wit fluoropyrimidine and platinum
- measurable or evaluable disease according to RECIST
- age, 18 years or older
- ECOG performance status 0 - 2
- 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
- life expectancy of ≥ 3 months
- signed written informed consent
You may not qualify if:
- more than one prior chemotherapy for metastatic disease
- severe co-morbid illness and/or active infections
- NCI CTCAE Grade 3 hemorrhage from any cause \< 4 weeks before enrollment
- preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart
- pregnant or lactating women
- active CNS metastases not controllable with radiotherapy or corticosteroids
- active and uncontrollable bleeding from gastrointestinal tract
- known history of hypersensitivity to study drugs
- prior treatment with sunitinib
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeeyun Lee, M.D., Ph.D.
Samsung Medical Center, Seoul, Korea
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2010
First Posted
November 10, 2010
Study Start
November 1, 2008
Primary Completion
April 1, 2012
Study Completion
October 1, 2012
Last Updated
April 9, 2013
Record last verified: 2012-01