Evaluation of Side Effects and Relative Activity of Two Chemotherapy Regimens in the Treatment Soft Tissue Sarcoma

PHASE2CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

August 31, 2004

Primary Completion Date

November 30, 2012

Study Completion Date

October 31, 2015

Conditions
Sarcoma, Soft Tissue
Interventions
DRUG

ifosfamide and doxorubicin vs gemcitabine and docetaxel

"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.~Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."

Trial Locations (1)

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

All Listed Sponsors
lead

University of Michigan Rogel Cancer Center

OTHER

NCT00189137 - Evaluation of Side Effects and Relative Activity of Two Chemotherapy Regimens in the Treatment Soft Tissue Sarcoma | Biotech Hunter | Biotech Hunter