Gemcitabine and Docetaxel With Radiation in Adults With Soft Tissue Sarcoma of the Extremities

Wake Forest University (WFU)

Status and phase: Suspended; Phase 1

Conditions: Soft Tissue Sarcoma

Treatments: Procedure: Surgical Resection; Radiation: Radiation; Drug: Gemcitabine; Drug: Docetaxel; Other: Blood draws

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04037527

P30CA012197 (U.S. NIH Grant/Contract)

CCCWFU 71117 (Other Identifier)

IRB00061621

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Neoadjuvant Chemotherapy Plus Radiation Therapy

Experimental group

Description:

Up to 6 cycles (once a week) of chemotherapy with a 3+3 dose escalating plan (from 100 mg to 300 mg for Gemcitabine; 10 mg to 25 mg for Docetaxel) along with radiation (five days a week) for up to 6 weeks.

Treatment:

Other: Blood draws

Drug: Docetaxel

Drug: Gemcitabine

Radiation: Radiation

Procedure: Surgical Resection