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Open Label, Randomized Multicenter Study Docetaxel + 5-fluorouracil + Cisplatin Compared to Cisplatin + 5-fluorouracil in Patients With Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease


Phase 3
18 Years
70 Years
Not Enrolling
Both
Stomach Neoplasms

Thank you

Trial Information

Open Label, Randomized Multicenter Study Docetaxel + 5-fluorouracil + Cisplatin Compared to Cisplatin + 5-fluorouracil in Patients With Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease


Inclusion Criteria:



- Gastric adenocarcinoma including adenocarcinoma of the esophagogastric junction,
histologically proven.

- Measurable and/or evaluable metastatic disease; if a single metastatic lesion is the
only manifestation of the disease, cytology or histology is mandatory. Locally
recurrent disease is accepted provided that there is at least one measurable lesion.

- Performance status Karnofsky index >70%

- Life expectancy of more than 3 months

- Adequate haematological parameters (Hb≥9g/dl, ANC≥2.0× 109/L, platelets ≥ 100× 109/L)

- Creatinine ≤ 1.25 UNL, serum magnesium should be within the normal value

- Total bilirubin ≤ 1 UNL, AST and ALT ≤ 2.5 UNL, alkaline phosphatase ≤ 5 UNL

- No prior palliative chemotherapy, previous adjuvant chemotherapy is allowed if more
than 12 months has elapsed between the end of adjuvant therapy and first relapse.

- At least 6 weeks from prior radiotherapy and 3 weeks from surgery

- Complete initial work-up within two weeks prior to first infusion for clinical
evaluation and biological work-up. Abdominal CT scan and chest X-rays are mandatory.

Exclusion Criteria:

- Pregnant or lactating women

- Patients with reproductive potential not implementing adequate contraceptive measures

- Other tumor type than adenocarcinoma

- Any prior palliative chemotherapy. Prior adjuvant chemotherapy with a first relapse
within 12 months from the end of adjuvant

- Prior treatment with taxanes. Prior CDDP as adjuvant chemotherapy with cumulative
dose > 300mg/m²

- Previous or current malignancies other than gastric carcinoma, with the exception of
adequately treated in situ carcinoma of the cervix uteri or non melanoma skin cancer

- Patients with known brain or leptomeningeal metastases

- Symptomatic peripheral neuropathy ≥ grade 2 by NCIC-CTG criteria

- Other serious illness or medical conditions:

- unstable cardiac disease despite treatment, myocardial infarction within 6
months prior to study entry

- history of significant neurologic or psychiatric disorders including dementia or
seizures

- active uncontrolled infection

- active disseminated intravascular coagulation

- other serious underlying medical conditions which could impair the ability of
the patient to participate in the study

- Concurrent treatment with corticosteroids except as use for the prophylactic
medication regimen, treatment of acute hypersensitivity reactions or unless chronic
treatment at low doses

- Definite contraindications for the use of corticosteroids

- Hypercalcemia not controlled by bisphosphonates and more than 12mg/100ml

- Liver impairment with AST or ALT more than 1.5UNL associated with alkaline
phosphatase more than 2.5UNL

- Concurrent or within 4 week period administration of any other experimental drugs

- Concurrent treatment with any other anti-cancer therapy

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 Time Frame:

Throughout the study period

Safety Issue:

No

Principal Investigator

Martin Thoenes

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

China: Food and Drug Administration

Study ID:

DOCET_L_02195

NCT ID:

NCT00811447

Start Date:

November 2008

Completion Date:

June 2012

Related Keywords:

  • Stomach Neoplasms
  • Neoplasms
  • Stomach Neoplasms

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