Oxaliplatin in Gastric Cancer

Oxaliplatin Phase II Trial in Association With 5FU and Folinic Acid in the Treatment of Advanced Unresectable or Metastatic Gastric Cancer.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00263354

Enrollment

Registered

2005-12-08

Start date

2003-10-31

Completion date

2006-07-31

Last updated

2010-11-09

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

Conditions

Stomach Neoplasms

Brief summary

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

Interventions

DRUGOxaliplatin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
To evaluate response rate according to RECIST criteria	—
To evaluate the progression-free survival in the ITT population	—

Secondary

Measure	Time frame
To evaluate the overall survival in the ITT population	—
To investigate safety using NCI-CTC criteria version 2	—

Outcome results

None listed

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