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

NCT ID: NCT00595985

Last Updated: 2009-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-01-31

Brief Summary

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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

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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.

Conditions

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Gastric Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

administer sorafenib 400mg bid until disease progression or intolerable toxicity or patients withdrawal of consent

Group Type EXPERIMENTAL

sorafenib

Intervention Type DRUG

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

Interventions

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sorafenib

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

Intervention Type DRUG

Other Intervention Names

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treatment group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Department of medical oncology, Cancer Hospital, Fuandan University

Principal Investigators

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Jin Li, PhD, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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Sorafenib-MGC

Identifier Type: -

Identifier Source: org_study_id

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