The Effect of Docetaxel or Gemcitabine-based Chemotherapy in East Asian and Caucasian Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

September 30, 2012

Study Completion Date

September 30, 2012

Conditions
Non Small Cell Lung CancerBreast Cancer
Interventions
DRUG

Docetaxel

Docetaxel will be administered at a dose of 75 mg/m2 given as a 1-hour intravenous infusion on day 1 of a 21-day cycle. Docetaxel is re-constituted in 500 mL of normal saline and infused through a peripheral or central venous line. Docetaxel (Taxotere®, Sanofi-Aventis Inc.) is available in 80 mg and 20 mg in 2 mL polysorbate 80, 13% (w/w) ethanol in Water for Injection.

DRUG

gemcitabine and carboplatin

"Gemcitabine (Gemzar®, Lily Inc.) is available in vials containing 1000 mg or 200 mg of active drug formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder.~Carboplatin (Spectrum Pharmaceuticals, Inc.) is supplied as a 10 mg/mL aqueous solution. Unopened vials of gemcitabine are stable when stored at controlled room temperature at 25°C, protected from bright light. It can be diluted in normal saline or 5% dextrose. The solution remains stable for 8 hours at 25°C after reconstitution.~Carboplatin will be administered as a 1-hour infusion on day 1 of a 21-day cycle. It will be given before gemcitabine at the dose to achieve an AUC of 5 using the Calvert formula.~Gemcitabine will be administered as a 30-minute infusion at the dose of 1000 mg/m2 in 250 mL over 30 minutes, on day 1 and 8 of a 21-day cycle. It will be given after carboplatin infusion."

Trial Locations (1)

Unknown

National University Hospital, Singapore

All Listed Sponsors
lead

National University Hospital, Singapore

OTHER

NCT00695994 - The Effect of Docetaxel or Gemcitabine-based Chemotherapy in East Asian and Caucasian Patients | Biotech Hunter | Biotech Hunter