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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00595985
• Other study ID #: Sorafenib-MGC
• Status: Terminated
• Phase: Phase 2
• First received: January 7, 2008
• Last updated: July 6, 2009
• Start date: July 2007
• Est. completion date: January 2009

Study information

• Verified date: July 2009
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	ShangHai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to progression		every six weeks	Yes
Secondary	toxicity		6 weeks	Yes