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Sponsored by: |
Central European Cooperative Oncology Group |
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Information provided by: | Central European Cooperative Oncology Group |
ClinicalTrials.gov Identifier: | NCT00294385 |
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.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: Docetaxel |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Phase III Study Comparing Concomitant Docetaxel Plus Gemcitabine to Sequential Therapy of Docetaxel Followed by Gemcitabine in Anthracycline-Pretreated Metastatic or Locally Recurrent Breast Cancer Patients |
Enrollment: | 430 |
Study Start Date: | June 2002 |
This is an open, multicenter, two-armed Phase III study
Patients will be randomized to either of the following two arms:
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.
Arm 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.
Bimonthly follow-up for patients without confirmed disease progression until progression of disease. Long-term follow-up for patients with confirmed disease progression will be done in 4 intervals.
For therapy control frequent blood chemistry and hematology, physical examination, weight control, potential adverse events and imaging procedures (CT, X-ray, MRI, Bone scan) am foreseen.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
2. Med. Abteilung - LKH-Steyr | |
Steyr, Austria, 4400 | |
Intere IV Krankenhaus Wels | |
Wels, Austria, 4600 | |
Hanusch KrankenhausHämatologisch-Onkologisches Zentrum | |
Vienna, Austria, 1140 | |
Bulgaria | |
SBALO National Oncology Center | |
Sofia, Bulgaria, 1756 | |
SBALO National Oncology Center | |
Sofia, Bulgaria, 1527 | |
Cancer Center Plovdiv | |
Plovdiv, Bulgaria, 4000 | |
Czech Republic | |
Charles University Prague, Dep of Oncology | |
Prague, Czech Republic | |
FN Bulovka | |
Prague, Czech Republic, 186 00 | |
FN Hradec Kralove | |
Hradec Kralove, Czech Republic, 500 02 | |
FN U sv. Anny | |
Brno, Czech Republic, 656 91 | |
Nemocnice Ceske Budejovice | |
Ceske, Czech Republic | |
Israel | |
"Sheba" Medical Center, Dep of Oncology | |
Tel Hashomer, Israel | |
Rambam Medical Center, Oncol. Dep | |
Haifa, Israel, 31096 | |
Tel Aviv Sourasky Medical Center, Div of Oncology | |
Tel Aviv, Israel | |
Lebanon | |
American University of Beirut, Medical Center | |
Beirut, Lebanon | |
Rizk Hospital | |
Beirut, Lebanon | |
Poland | |
Klinika Onkologii CMuJ | |
Krakow, Poland | |
Slovakia | |
Nomocnica Sv. Alzbety, Narodny Onkologicky Ustav | |
Bratislava, Slovakia |
Principal Investigator: | Christoph Wiltschke, Prof | Univ. Klinik f. Innere Medizin I |
Study ID Numbers: | CECOG/BC 1.3.002 |
Study First Received: | February 20, 2006 |
Last Updated: | May 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00294385 |
Health Authority: | Austria: Federal Ministry for Health and Women |
Breast Cancer Docetaxel |
Docetaxel Skin Diseases Breast Neoplasms |
Gemcitabine Breast Diseases Recurrence |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |