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A Randomized Phase II Study of Docetaxel in Combination With Oxaliplatin With or Without 5-FU or Capecitabine in Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease


Phase 2
18 Years
N/A
Not Enrolling
Both
Stomach Neoplasms

Thank you

Trial Information

A Randomized Phase II Study of Docetaxel in Combination With Oxaliplatin With or Without 5-FU or Capecitabine in Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease


The purpose of this study (Part II) was to evaluate the time to progression in the 3 arms at
an optimal dose level of docetaxel and oxaliplatin defined during a prior pilot (Part I)
phase study. The estimated duration of treatment was to be 6 months. Treatment was to be
administered up to progression, unacceptable toxicities, or withdrawal of consent. The
reason and date of removal of all participants was documented on the case report form.

Participants who ended treatment but had not yet progressed (e.g. unacceptable toxicities or
withdrawal of consent) were be followed every 8 weeks with a complete tumor assessment until
documented progression or further anti-tumor therapy. Then, they would be followed every 3
months after progression for survival status; date of death or progression were reported.
Participants who ended treatment for progression, were to be followed every 3 months until
death. Date of death was reported. The planned duration of the study was 30 months.

Inclusion Criteria


Inclusion criteria:

- Histologically proven gastric adenocarcinoma, including adenocarcinoma of the
gastro-oesophageal junction

- Metastatic or locally recurrent disease

- Prior adjuvant (and/or neo-adjuvant) chemotherapy with 5-Fluorouracil, Cisplatin,
epirubicin is allowed provided that the patient has relapsed > 12 months after the
end of the chemotherapy

- Performance status Karnofsky index > 70

- Hematology within 7 days before randomization:Hemoglobin ≥10g/dl, Absolute Neutrophil
Count ≥2.0 10^9/L, platelets ≥100 x 10^9/L

- Blood chemistry within 7 days before randomization:Total bilirubin ≤1x Upper Normal
Limit(UNL), Aspartate Aminotransferase (AST) Serum Glutamic Oxaloacetic Transaminase
SGOT) and Alanine Aminotransferase (ALT)Serum Glutamate Pyruvate Transaminase(SGPT)
≤2.5xUNL, alkaline phosphatase ≤ 5x UNL, provided that AST or ALT > 1.5 x UNL is not
associated with alkaline phosphatase > 2.5 x UNL; creatinine ≤1.25x UNL or 1.25x UNL
< creatinine ≤1.5x UNL and calculated/measured creatinine clearance ≥60 ml/min)

- Measurable and/or evaluable metastatic disease

Exclusion criteria:

- Any prior palliative chemotherapy

- Neurosensory symptoms National Cancer Institute Common Toxicity Criteria for Adverse
Events grade≥2

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Progression

Outcome Description:

The number of months measured from the day of randomization to the first tumor progression according to World Health Organization (WHO) criteria evaluation of cancer response, or death from any cause. WHO Criteria for Progressive Disease: ≥ 25% increase in the size of at least one bidimensionally or unidimensionally measurable lesion.

Outcome Time Frame:

every 8 weeks up to a maximum of 36 months

Safety Issue:

No

Principal Investigator

Jean-Philippe Aussel

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

DOCOX_C_00082

NCT ID:

NCT00382720

Start Date:

September 2006

Completion Date:

April 2010

Related Keywords:

  • Stomach Neoplasms
  • Neoplasms
  • Stomach Neoplasms

Name

Location

Sanofi-Aventis Administrative OfficeBridgewater, New Jersey  08807