Oxaliplatin in Gastric Cancer

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2006-07-31

Brief Summary

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To determine the objective response to oxaliplatin/5FU/leucovorin combination chemotherapy in patients with advanced unresectable or metastatic gastric cancer.

Detailed Description

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Conditions

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Stomach Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Oxaliplatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ECOG performance status of 0-2.
* Histologically proven gastric or gastro-esophageal junction adenocarcinoma.
* At least unidimensional measurable disease. If a unique metastasis constitutes the only disease sign, it requires histological confirmation.
* First line locally unresectable or metastatic gastric cancer.
* Relapsing gastric cancer after local and/or systemic treatment with a post-surgical period of at least 4 weeks, a post-adjuvant or neoadjuvant chemoradiotherapy period of at least 6 months.
* Serum bilirubin \< 2 mg/dl
* Serum creatinine \< or = 2 mg/dl
* Hemoglobin \> or = 10 g/dl
* Absolute neutrophil count \> or = 2000/dl
* Platelet count \>or = 100, 000/dl
* AST/ALT \< or = 2.5 time-fold the institutional normal upper limit
* Alkaline phosphatase \< or = 5 time-fold the institutional normal upper limit
* Imagenological evaluation of the patient at least 2 weeks prior to the drug infusion
* Laboratory tests at least 1 week prior to the first infusion
* Patient available for follow up and able to answer to the quality of life questionnaire

Exclusion Criteria

* Symptomatic sensorial peripheral neuropathy
* Uncontrolled concomitant disease
* Another malignant neoplastic disease diagnosed within the previous 5 years to the diagnosis of advanced or metastatic gastric cancer, with the exception of 'in situ' cervix carcinoma or non-melanoma skin cancer
* Concomitant antitumoral treatment
* Cerebral metastases
* Unstable heart disease, even though in treatment
* Myocardial infarction within the last 6 months
* Radiotherapy within the last 6 weeks, surgery within the last 4 weeks, or chemotherapy within the last 6 months.
* Pregnancy or nursing ( or women in reproductive life without adequate contraception)
* Significant neurological or psychiatric disorders.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jesus M. Ruiz, MD

Role: STUDY_DIRECTOR

Sanofi

Other Identifiers

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L_8915

Identifier Type: -

Identifier Source: org_study_id