Overview
The purpose of this Phase 1 research study is to obtain data or information on the safety and effectiveness of the combination of gemcitabine, docetaxel with radiation.
Description
Primary Objective:
• To determine the maximum tolerated doses Gemcitabine and Taxotere when given weekly with concurrent radiation in the neoadjuvant setting for patients with soft tissue sarcoma of the extremities.
Secondary Objective:
• To evaluate immunological changes induced by gemcitabine and docetaxel with radiation in patient with high risk-soft tissue sarcomas in blood. This would include T cell subsets, NK, and dendritic cells and tumor macrophages all of which make up the tumor microenvironment.
Long term follow-up will occur every 3-4 months for 24 months in person or video consultation.
Eligibility
Inclusion Criteria:
- 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-op radiation.
- Age greater than or equal to 18 years. No children will be enrolled on this protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 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.
Exclusion Criteria:
- 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.