Oxaliplatin in Gastric Cancer

NCT00263354 | Completed Phase 2

• 1 other identifier: L_8915
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Stomach Neoplasms

Outcome Measures

Primary Outcomes (2)

• To evaluate response rate according to RECIST criteria

• To evaluate the progression-free survival in the ITT population

Secondary Outcomes (2)

• To evaluate the overall survival in the ITT population

• To investigate safety using NCI-CTC criteria version 2

Interventions

Oxaliplatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Jesus M. Ruiz, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 7, 2005
• First Posted: December 8, 2005
• Study Start: October 1, 2003
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: November 9, 2010

Record last verified: 2010-08