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Study Comparing Concomitant Docetaxel + Gemcitabine to Sequential Therapy of Docetaxel Followed by Gemcitabine

NCT00294385 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2011-06-23

No results posted yet for this study

Summary

The purpose of this study is to compare the Time To Disease Progression (TTDP) between those patients with unresectable, locally recurrent or metastatic breast cancer who are treated with concomitant Docetaxel plus Gemcitabine to those patients treated with sequential therapy of Docetaxel followed by Gemcitabine.

Conditions

Interventions

DRUG

Docetaxel

DRUG

Gemcitabine, Docetaxel

Arm A (concomitant arm), Gemcitabine 1000 mglm2 will be administered intravenously on Days 1 and 8, repeated on Day 22. Docetaxel 75 mg/m2 will be given on Day 8 (before Gemcitabine), repeated on Day 22. This 3-week schedule defines a cycle of treatment for this arm. Overall 8 cycles will be administered.

DRUG

Docetaxel

rm B (sequential arm) four cycles of Docetaxel 100 mg/m2 an Day 1, repeated an Day 22, followed by four cycles of Gemcitabine 1250 mg/m2 an a Day 1 and 8, repeated an Day 22, will be given. Both drugs will be administered in a 3-week schedule.

Sponsors & Collaborators

  • Central European Cooperative Oncology Group

    lead OTHER

Principal Investigators

  • Christoph Wiltschke, Prof · Univ. Klinik f. Innere Medizin I

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-30
Completion
2005-10-31

Countries

  • Austria
  • Bulgaria
  • Czechia
  • Israel
  • Lebanon
  • Poland
  • Slovakia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00294385 on ClinicalTrials.gov