Weekly Docetaxel and Fixed-Dose Rate Gemcitabine Combination Chemotherapy

PHASE2UnknownINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 30, 2008

Primary Completion Date

September 30, 2010

Study Completion Date

September 30, 2010

Conditions
Sarcoma
Interventions
DRUG

Gemcitabine and Docetaxel

"Drug and schedule~* Gemcitabine 1000 mg/m2 IV over 10 mg/m2/min (D1, D8)~* Docetaxel 35 mg/m2 IV (D1, D8) .. every 21 days~Dose modification~* Treatment should be delayed if the ANC\<1,500/ mm3, or if the platelet count \<75,000/mm3 on the first day of the next cycle.~* Gemcitabine \& docetaxel are omitted on day 8, when ANC is less than 1000/mm3 or platelet count is less than 50,000/mm3; it is reduced by 25% if the ANC is between 1,000 and 1,500/mm3 or the platelet count is between 50,000 and 75,000/mm3 Study design Treatment should consist of at least 2 cycles unless rapid disease progression or unacceptable toxicities occur after one cycle of chemotherapy.~Patients with response or no change will receive 2 additional cycles."

Sponsors
All Listed Sponsors
collaborator

Severance Hospital

OTHER

collaborator

Korea University Anam Hospital

OTHER

collaborator

Samsung Medical Center

OTHER

lead

Asan Medical Center

OTHER

NCT00807261 - Weekly Docetaxel and Fixed-Dose Rate Gemcitabine Combination Chemotherapy | Biotech Hunter | Biotech Hunter