Oxaliplatin in Gastric Cancer

Stomach Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00263354
• Other study ID #: L_8915
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2005
• Last updated: November 5, 2010
• Start date: October 2003
• Est. completion date: July 2006

Study information

• Verified date: August 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Institute of Public Health, Health Secretariat
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Drug:
• Oxaliplatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate response rate according to RECIST criteria
Primary	To evaluate the progression-free survival in the ITT population
Secondary	To evaluate the overall survival in the ITT population
Secondary	To investigate safety using NCI-CTC criteria version 2