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Study of Cetuximab to Treat Gastric Cancer

NCT ID: NCT00699881

Last Updated: 2009-12-23

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-10-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of cetuximab combined with FOLFIRI in patients with advanced gastric cancer who failed first-line chemotherapy

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 cetuximab combined with FOLFIRI in metastatic colorectal cancer, we design this clinical trial to evaluate the efficacy and safety of cetuximab combined with FOLFIRI for A/MGC patients as a second line treatment.

Conditions

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Gastric Cancer

Keywords

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Time to Progression Toxicity Overall survival Response rate Quality of live

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

administer cetuximab in combination with modified FOLFIRI

Group Type EXPERIMENTAL

cetuximab

Intervention Type DRUG

cetuximab 400mg/m2 as initial dose, subsequently at 250mg/m2 weekly dose. CPT-11 180 mg/m2 CF 200 mg/m2 5Fu 400mg/m2 bolus, followed by 2.4g/m2 continuously intravenous infusion for 46 hours, days 1 and 15, every 4 weeks per cycle

Interventions

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cetuximab

cetuximab 400mg/m2 as initial dose, subsequently at 250mg/m2 weekly dose. CPT-11 180 mg/m2 CF 200 mg/m2 5Fu 400mg/m2 bolus, followed by 2.4g/m2 continuously intravenous infusion for 46 hours, days 1 and 15, every 4 weeks per cycle

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 ≤ 1
* 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), and 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

References

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Liu X, Guo W, Zhang W, Yin J, Zhang J, Zhu X, Liu T, Chen Z, Wang B, Chang J, Lv F, Hong X, Wang H, Wang J, Zhao X, Wu X, Li J. A multi-center phase II study and biomarker analysis of combined cetuximab and modified FOLFIRI as second-line treatment in patients with metastatic gastric cancer. BMC Cancer. 2017 Mar 14;17(1):188. doi: 10.1186/s12885-017-3174-z.

Reference Type DERIVED
PMID: 28288572 (View on PubMed)

Other Identifiers

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EMR 62202- 806

Identifier Type: -

Identifier Source: org_study_id