Sunitinib + Docetaxel as Second-line Treatment in Gastric Cancer

NCT ID: NCT01238055

Last Updated: 2013-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2012-10-31

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.

Conditions

Advanced Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Docetaxel + Sunitinib

Docetaxel and Sunitinib

Group Type: EXPERIMENTAL

Docetaxel + Sunitinib

Intervention Type: DRUG

Docetaxel 60 mg/m2 iv, every 3 weeks

Sunitinib 37.5 mg qd daily, every 3 weeks

Docetaxel

Docetaxel only

Group Type: ACTIVE_COMPARATOR

Docetaxel only

Intervention Type: DRUG

Docetaxel 60 mg/m2 iv

Interventions

Docetaxel + Sunitinib

Docetaxel 60 mg/m2 iv, every 3 weeks

Sunitinib 37.5 mg qd daily, every 3 weeks

Intervention Type: DRUG

Docetaxel only

Docetaxel 60 mg/m2 iv

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeeyun Lee, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center, Seoul, Korea

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2008-09-031

Identifier Type: -

Identifier Source: org_study_id