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

NCT04037527 | Terminated Phase 1 DMC FDA Drug

• 3 other identifiers: IRB00061621P30CA012197CCCWFU 71117
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Soft Tissue Sarcoma

Keywords

Grade II sarcoma; Grade III sarcoma

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose Chemotherapy and Radiation

  Maximum tolerated dose of Gemcitabine and Taxotere and radiation will be completed by monitoring toxicities and using the 3+3 dose escalation plan.

  Up to 8 weeks

• Number of Toxicity Incidences

  Complication/side effects from the chemotherapy combination of gemcitabine and taxotere concurrent with radiation will be assessed by toxicity counts/rates presented descriptively by toxicity, severity, and dose level using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  8 weeks post-surgery

Secondary Outcomes (1)

• Number of Immunological Changes in Blood

  8 weeks post-surgery

Study Arms (1)

Neoadjuvant Chemotherapy Plus Radiation Therapy

EXPERIMENTAL

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.

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

Interventions

Gemcitabine DRUG

Gemcitabine will be administered on day 1 of each one-week cycle for 6 cycles concurrently with radiation to the extremity on a 3+3 escalating dose (100 mg/m² to 300 mg/m²)

Neoadjuvant Chemotherapy Plus Radiation Therapy

Docetaxel DRUG

Docetaxel will be administered on day 1 of each one-week cycle for 6 cycles concurrently with radiation to the extremity (10 mg/m² to 25 mg/m²).

Also known as: Taxotere

Neoadjuvant Chemotherapy Plus Radiation Therapy

Radiation RADIATION

Radiation is to be done with standard preop dose of 50 Gy but at lower doses per fraction. Thus 50.4 Gy in 28 FX. Radiation will be given for 5 days (Monday - Friday) every week for approx. 6 weeks.

Neoadjuvant Chemotherapy Plus Radiation Therapy

Surgical Resection PROCEDURE

Upon completing neoadjuvant chemotherapy plus radiation therapy, surgical resection will occur.

Neoadjuvant Chemotherapy Plus Radiation Therapy

Blood draws OTHER

Before treatment, blood (about 2 tubes of 10 mls each) to better understand some aspects of participants' immune system before chemotherapy.

Neoadjuvant Chemotherapy Plus Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Gemcitabine; Docetaxel; Radiation; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Physical Phenomena; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Shailaja Raj, MRCP

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: July 30, 2019
• Study Start: August 18, 2020
• Primary Completion: June 18, 2024
• Study Completion: June 18, 2024
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)