Sorafenib as a Second Line Treatment in Patients With Advanced or Metastatic Gastric Cancer

Phase II Trial of Sorafenib as Second Line Therapy in Patients With Advanced or Metastatic Gastric Cancer

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00595985

Enrollment

Registered

2008-01-16

Start date

2007-07-31

Completion date

2009-01-31

Last updated

2009-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Time to Progression, Toxicity, Overall survival, Response rate, Quality of live, Toxicities

Brief summary

The purpose of this study is to evaluate the efficacy and tolerability of sorafenib as second line treatment in patients with Advanced or Metastatic Gastric Cancer (A/MGC).

Detailed description

Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, there is no standard regimen for patients with A/MGC as second line treatment. Based on the promising results of sorafenib in primary hepatic carcinoma and renal cancer, we design this clinical trial to evaluate the efficacy, time to progression and overall survival of sorafenib for A/MGC patients as a second line treatment.

Interventions

DRUGsorafenib

sorafenib 400mg bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Histologically confirmed advanced or metastatic adenocarcinoma of the stomach * ECOG performance scale ≤ 2 * At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan) * Adequate hepatic, renal, heart, and hematologic functions: * platelets\>80 × 109/L * neutrophil\>2.0 × 109/L * serum creatinine ≤ 1.5mg/dl * total bilirubin within upper limit of normal(ULN) * serum transaminase ≤ 2.5 × the ULN

Exclusion criteria

* Pregnant or lactating women * Concurrent cancer * History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * Neuropathy, brain, or leptomeningeal involvement * Uncontrolled significant comorbid conditions and previous radiotherapy

Design outcomes

Primary

Measure	Time frame
time to progression	every six weeks

Secondary

Measure	Time frame
toxicity	6 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026