Gemcitabine and Docetaxel with Radiation Therapy before Surgery for the Treatment of High Grade and Greater than 5 cm Soft Tissue Sarcoma of the Extremities
- Patients must have a histologically or cytologically confirmed grade II or III soft tissue sarcoma that is considered to be resectable and are candidates for pre-operation (op) radiation
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or double-barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document
- Patients taking concurrent hormonal therapy, biologic or other chemotherapy are excluded except women on hormonal contraceptives
- Patients taking an investigational agent are excluded
- Pregnant and nursing women are excluded
- Patients who require amputation for local control
- Patients who underwent unplanned excision or other previous surgery involving the affected extremity
- Patients with sarcoma subtypes for which established chemotherapeutic regimens exist
- History of radiation to the limb
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.
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 8 weeks.
Trial Phase Phase I
Trial Type Treatment
Wake Forest University Health Sciences
Shailaja Ks Raj
- Primary ID WFBCCC 71117
- Secondary IDs NCI-2020-04227
- Clinicaltrials.gov ID NCT04037527