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CompletedNCT00611507Updated Mar 25, 2008

A Phase II Study of Oxaliplatin in Association With 5FU and Folinic Acid in the Treatment of Subjects With Non-Surgical or Advanced Metastatic Gastric Cancer

A Phase 2 interventional study of Oxaliplatin, 5-Fluorouracil in Stomach Neoplasms, sponsored by Sanofi. Completed at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-03-25.

Sponsored by Sanofi · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This phase II trial will evaluate, in first line advanced or metastatic gastric cancer, the efficacy and tolerance of another oxaliplatin, 5FU bolus combination already tested in advanced colorectal cancer

02

Conditions studied

  • Stomach Neoplasms

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03

In context

Stomach Neoplasms

2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.

This study's enrollment of 21 is below the median of 66 across 2,143 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Histologically proven gastric or gastroesophagic junction adenocarcinoma
  • Measurable disease at least in a unidimensional manner. If a unique metastasis constitutes the only disease symptom, histological confirmation will be required
  • Metastatic or locally non-surgical primary gastric cancer
  • Recurrent gastric cancer after local and/or systemic treatment with a post-surgical period of at least 4 weeks, a post-adjuvant chemotherapy period or a neo-adjuvant chemo-radiotherapy of at least 6 months
  • Serum bilirubin\< 2 mg/dl
  • Serum creatinine \< or =to 2 times normal superior limit
  • Absolute neutrophil count > or =to 2000/dl
  • Platelet count > or =to 100000/dl
  • Hemoglobin > or =to 10 g/dl
  • AST/ALT \< or =to 2.5 times normal superior institutional limit
  • Alkaline phosphatase \< or =to 5 times the normal superior institutional limit
  • Age > 18 years
  • Performance Status ECOG 0-2
  • Written informed consent signed and dated

Exclusion criteria

Exclusion Criteria:

  • Symptomatic sensory peripheral neuropathy
  • Uncontrolled concomitant disease.(e.g. severe diabetes mellitus, arterial hypertension)
  • Any other malignancy diagnosed within 5 years previous to the gastric cancer, with the exception of " in situ " cervix carcinoma or non-melanoma skin cancer
  • Concomitant anti-tumoral treatment
  • Cerebral metastases
  • Unstable heart disease, even though under treatment
  • Myocardial infarction within the last 6 months
  • Pregnancy or nursing (or women in reproductive life without adequate contraception)
  • Significant neurological or psychiatric disorders
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Interventions

  • DrugOxaliplatin, 5-Fluorouracil

    Drug pages: Oxaliplatin · Fluorouracil

    5FU 500 mg/m² per week in IV bolus infusion during 30 min AF 20mg/m²/week in infusion, during 10-20 minutes prior 5FU infusion; Eloxatin 85 mg/m² as IV infusion 2-6 hours, every 2 weeks. Three weeks of treatment, one week rest.

    Also known as: Eloxatin, 5FU

06

What researchers measure

Primary outcomes

  1. Response rate - RECIST criteria (unidimensional)

    Time frame: During the study conduct

Secondary outcomes

  1. Progression-free Survival (PFS)

    Time frame: During the study conduct

07

Study locations

1 site
  • Sanofi-Aventis
    Bogotá, Colombia
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2002 and a completion of Apr 2004. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 28, 2008
First posted
Feb 11, 2008
Start
Nov 2002
CompletionActual
Apr 2004
Last update
Mar 25, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 25, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00611507
Lead sponsor
Sanofi
First posted
Feb 11, 2008
Start date
Nov 2002
Completion
Apr 2004
Last update
Mar 25, 2008

Study contacts

Juan Carlos Gomez
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Oxaliplatin · Fluorouracil

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