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

Wake Forest University (WFU) logo

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)

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

Trial contacts and locations

1

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Central trial contact

Ashley Fansler, RN

Data sourced from clinicaltrials.gov

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