Clinical trial NCT00811447: Taxotere New Indication - Gastric Cancer Treatment Registration Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stomach Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-12-19
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary objective:

To detect a statistically significant increase in time to progression (TTP) of disease for the test group (Taxotere® \[Docetaxel\] combined with cisplatin and 5-fluorouracil \[TCF\]) relative to the control group (Cisplatin combined with 5-fluorouracil\[CF\])

Secondary objectives:

* To detect a statistically significant increase in overall survival (OS) for the test group relative to the control group.
* To compare response rate (RR), time to treatment failure (TTF), duration of responses, safety profiles, quality of life (QOL), and disease-related symptoms.


Eligibility criteria: 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.

Primary outcomes:
measure: Time to progression
timeFrame: Throughout the study period
Secondary outcomes:
measure: Safety profile
timeFrame: Throughout the study period
measure: Overall survival
timeFrame: From beginning to end of study
measure: Tumor response
timeFrame: every 8 weeks
measure: Clinical toxicities/symptomatology
timeFrame: Throughout the study period
measure: Laboratory toxicities/symptomatology
timeFrame: Throughout the study period
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Martin Thoenes
role: STUDY_DIRECTOR
References: