Sunitinib + Docetaxel as Second-line Treatment in Gastric Cancer

Study Overview
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Brief Summary
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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.

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

Official Title
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Randomized Phase II Trial of Sunitinib and Docetaxel in Advanced Gastric Cancer Patients Who Had Prior Chemotherapy With Fluoropyrimidine and Platinum

Conditions
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Advanced Gastric Cancer

Intervention / Treatment
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* Drug: Docetaxel + Sunitinib
* Drug: Docetaxel only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docetaxel + Sunitinib<br>Docetaxel and Sunitinib | Drug: Docetaxel + Sunitinib<br>* Docetaxel 60 mg/m2 iv, every 3 weeks Sunitinib 37.5 mg qd daily, every 3 weeks<br>|
| Active Comparator: Docetaxel<br>Docetaxel only | Drug: Docetaxel only<br>* Docetaxel 60 mg/m2 iv<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to progression |  | every 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 12 months | 
| Overall survival |  | 12 months | 
| Progression free survival |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced gastric cancer, sunitinib, docetaxel, fluoropyrimidine platinum based chemotherapy