Sunitinib + Docetaxel as Second-line Treatment in Gastric Cancer

Samsung Medical Center

Status and phase: Completed; Phase 2

Conditions: Advanced Gastric Cancer

Treatments: Drug: Docetaxel + Sunitinib; Drug: Docetaxel only

Study type: Interventional

Funder types: Other

Identifiers

NCT01238055

2008-09-031

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Docetaxel + Sunitinib

Experimental group

Description:

Docetaxel and Sunitinib

Treatment:

Drug: Docetaxel + Sunitinib

Docetaxel

Active Comparator group

Description:

Docetaxel only

Treatment:

Drug: Docetaxel only