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Open Label, Randomized Multicentre Phase II/III Study of Docetaxel in Combination With Cisplatin (CDDP) or Docetaxel in Combination With 5-Fluorouracil (5-FU) and CDDP Compared to the Combination of CDDP and 5-FU in Patients With Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease


Phase 2/Phase 3
18 Years
75 Years
Not Enrolling
Both
Stomach Neoplasm

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Trial Information

Open Label, Randomized Multicentre Phase II/III Study of Docetaxel in Combination With Cisplatin (CDDP) or Docetaxel in Combination With 5-Fluorouracil (5-FU) and CDDP Compared to the Combination of CDDP and 5-FU in Patients With Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease


Inclusion Criteria:



- Patient's consent form obtained, signed and dated before beginning specific protocol
procedures.

- 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
(e.g. lymph node).

- Performance status Karnofsky index > 70%.

- Life expectancy of more than 3 months.

- Adequate haematological and biochemistry parameters

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

Exclusion Criteria:

- Pregnant or lactating women.

- Patients (M/F) with reproductive potential not implementing adequate contraceptive
measures.

- Other tumor type than adenocarcinoma (leiomyosarcoma ; lymphoma).

- Any prior palliative chemotherapy. Prior adjuvant (and/or neo-adjuvant) chemotherapy
with a first relapse within 12 months from the end of adjuvant (or neo-adjuvant).

- Prior treatment with taxanes. Prior CDDP as adjuvant (and/or neo-adjuvant)
chemotherapy with cumulative dose > 300 mg/m².

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

to detect a significant increase in time to progression in favor of docetaxel plus cisplatin and 5-FU compared to cisplatin plus 5-FU. Tumor assessments (assessed with WHO criteria) had to be performed every 8 weeks until progression

Principal Investigator

Jaffer Ajani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

MD Anderson Cancer Center, Houston, Texas, US

Authority:

United States: Food and Drug Administration

Study ID:

EFC6044

NCT ID:

NCT00290966

Start Date:

October 1998

Completion Date:

May 2003

Related Keywords:

  • Stomach Neoplasm
  • docetaxel
  • stomach neoplasm
  • Neoplasms
  • Stomach Neoplasms

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