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

PHASE3CompletedINTERVENTIONAL
Enrollment

430

Participants

Timeline

Start Date

June 30, 2002

Study Completion Date

October 31, 2005

Conditions
Breast Cancer
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.

Trial Locations (18)

1140

Hanusch KrankenhausHämatologisch-Onkologisches Zentrum, Vienna

1527

SBALO National Oncology Center, Sofia

1756

SBALO National Oncology Center, Sofia

4000

Cancer Center Plovdiv, Plovdiv

4400

2. Med. Abteilung - LKH-Steyr, Steyr

4600

Intere IV Krankenhaus Wels, Wels

31096

Rambam Medical Center, Oncol. Dep, Haifa

656 91

FN U sv. Anny, Brno

Unknown

Nemocnice Ceske Budejovice, Ceske

Charles University Prague, Dep of Oncology, Prague

Tel Aviv Sourasky Medical Center, Div of Oncology, Tel Aviv

"Sheba Medical Center, Dep of Oncology", Tel Litwinsky

American University of Beirut, Medical Center, Beirut

Rizk Hospital, Beirut

Klinika Onkologii CMuJ, Krakow

Nomocnica Sv. Alzbety, Narodny Onkologicky Ustav, Bratislava

500 02

FN Hradec Kralove, Hradec Králové

186 00

FN Bulovka, Prague

All Listed Sponsors
lead

Central European Cooperative Oncology Group

OTHER

NCT00294385 - Study Comparing Concomitant Docetaxel + Gemcitabine to Sequential Therapy of Docetaxel Followed by Gemcitabine | Biotech Hunter | Biotech Hunter