Taxotere New Indication - Gastric Cancer Treatment Registration Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00811447
First received: December 18, 2008
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

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.

Condition Intervention Phase
Stomach Neoplasms
Drug: 5-fluorouracil
Drug: Cisplatin
Drug: Docetaxel
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Time to progression [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety profile [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: From beginning to end of study ] [ Designated as safety issue: No ]
  • Tumor response [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
  • Clinical toxicities/symptomatology [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
  • Laboratory toxicities/symptomatology [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]

Enrollment: 243
Study Start Date: November 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Administration of docetaxel 60 mg/m² on Day 1, Cisplatin 60 mg/m² after the end of the docetaxel infusion and 5-fluorouracil (5-FU) 600 mg/m²/day from Day 1 after the end of the cisplatin infusion to Day 5.
Drug: 5-fluorouracil
600 mg/m²/day intravenous
Drug: Cisplatin
60 mg/m² or 75 mg/m² intravenous
Drug: Docetaxel
60 mg/m² intravenous
Active Comparator: 2
Cisplatin 75 mg/m² on Day 1, 5-FU 600 mg/m²/day from Day 1 after the end of the cisplatin infusion to Day 5.
Drug: 5-fluorouracil
600 mg/m²/day intravenous
Drug: Cisplatin
60 mg/m² or 75 mg/m² intravenous

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811447

Locations
China
Sanofi-Aventis Administrative Office
Shanghai, China
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Martin Thoenes Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00811447     History of Changes
Other Study ID Numbers: DOCET_L_02195
Study First Received: December 18, 2008
Last Updated: August 30, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 22, 2014