Sunitinib + Docetaxel as Second-line Treatment in Gastric Cancer

Advanced Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01238055
• Other study ID #: 2008-09-031
• Status: Completed
• Phase: Phase 2
• First received: January 7, 2010
• Last updated: April 8, 2013
• Start date: November 2008
• Est. completion date: October 2012

Study information

• Verified date: January 2012
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: October 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Docetaxel + Sunitinib
Docetaxel 60 mg/m2 iv, every 3 weeks Sunitinib 37.5 mg qd daily, every 3 weeks
• Docetaxel only
Docetaxel 60 mg/m2 iv

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to progression		every 6 weeks	No
Secondary	Response rate		12 months	Yes
Secondary	Overall survival		12 months	Yes
Secondary	Progression free survival		12 months	Yes