This phase I trial investigates the side effects and best dose of gemcitabine and docetaxel when given together with radiation therapy, and to see how well the combination works before surgery in treating patients with high grade soft tissue sarcoma of the upper or lower limbs (extremities) that is over 5 cm in size. Chemotherapy drugs, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving gemcitabine, docetaxel, and radiation therapy to patients with soft tissue sarcoma of the extremities may lead to a reduction in the size of the tumor prior to surgery. It may also lead to better surgical outcomes and/or reduce the risk of the tumor spreading to other parts of the body.
Additional locations may be listed on ClinicalTrials.gov for NCT04037527.
Locations matching your search criteria
United States
North Carolina
Winston-Salem
Wake Forest University Health SciencesStatus: Temporarily closed to accrual
Contact: Shailaja Ks Raj
Phone: 336-716-7972
PRIMARY OBJECTIVE:
I. To determine the maximum tolerated doses of gemcitabine hydrochloride (gemcitabine) and docetaxel (Taxotere) when given weekly with concurrent radiation in the neoadjuvant setting for patients with soft tissue sarcoma of the extremities.
SECONDARY OBJECTIVE:
I. To evaluate immunological changes induced by gemcitabine and docetaxel with radiation in patients with high risk-soft tissue sarcomas in blood.
OUTLINE: This is a dose-escalation study of gemcitabine and docetaxel.
Patients receive gemcitabine intravenously (IV) over 30 minutes and docetaxel IV over 1 hour on day 2 (Tuesday). Patients also undergo concurrent radiation therapy daily Monday-Friday per the radiation oncologist’s recommendations. Treatment repeats every 7 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. 4-5 weeks after the last radiation therapy treatment, patients undergo standard of care surgical resection.
After completion of study treatment, patients are followed up at 7-10 weeks then every 3-4 months for 24 months.
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorShailaja Ks Raj
