Sunitinib + Docetaxel as Second-line Treatment in Gastric Cancer

Phase 2

Completed

• Conditions: Advanced Gastric Cancer
• Interventions: Drug: Docetaxel + Sunitinib; Drug: Docetaxel only

• Registration Number: NCT01238055
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-11
• Study First Submitted: 2010-01-07
• Study First Submitted QC: 2010-11-09
• Study First Posted: 2010-11-10
• Status Verified: 2012-01
• Primary Completion: 2012-04
• Study Completion: 2012-10
• Last Update Submitted: 2013-04-08
• Last Update Posted: 2013-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Docetaxel + Sunitinib	Docetaxel + Sunitinib	Docetaxel and Sunitinib
Docetaxel	Docetaxel only	Docetaxel only

Primary Outcome Measures

Name	Time	Method
time to progression	every 6 weeks

Secondary Outcome Measures

Name	Time	Method
Progression free survival	12 months
Response rate	12 months
Overall survival	12 months

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of