Gemcitabine Hydrochloride, Docetaxel, and Radiation Therapy in Treating Patients With Uterine Sarcoma That Has Been Removed By Surgery

A Pilot Safety and Toxicity Trial of Adjuvant Chemotherapy With Gemcitabine and Docetaxel and Radiation Therapy for Completely Resected Uterine Leiomyosarcoma

This pilot clinical trial studies gemcitabine hydrochloride, docetaxel, and radiation therapy in treating patients with uterine sarcoma that has been removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and docetaxel, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving combination chemotherapy with radiation therapy may kill any tumor cells that remain after surgery.

Study Overview

• Status: Terminated
• Conditions: Uterine Corpus Leiomyosarcoma; Stage IIA Uterine Sarcoma; Stage IIB Uterine Sarcoma; Stage IIIA Uterine Sarcoma; Stage IIIB Uterine Sarcoma; Stage IIIC Uterine Sarcoma; Stage IVA Uterine Sarcoma; Stage IVB Uterine Sarcoma; Stage IA Uterine Sarcoma; Stage IB Uterine Sarcoma; Stage IC Uterine Sarcoma
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Drug: Docetaxel; Drug: Gemcitabine Hydrochloride; Radiation: External Beam Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Radiation: Internal Radiation Therapy

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the toxicity and tolerability of adjuvant pelvic radiation in combination with gemcitabine (gemcitabine hydrochloride)/docetaxel chemotherapy in patients with stage 1 and 2 surgically-resected uterine leiomyosarcoma.

SECONDARY OBJECTIVES:

I. To assess the two year recurrence-free survival in patients with uterine leiomyosarcoma treated with chemotherapy and radiation therapy including defining the patterns of recurrence in patients with uterine leiomyosarcoma who were treated with this regimen.

OUTLINE:

CHEMOTHERAPY: Patients receive gemcitabine hydrochloride intravenously (IV) over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or intensity modulated radiation therapy (IMRT) over 3 weeks. Patients then undergo external beam radiation therapy (EBRT) once daily (QD) 5 days a week for 5 weeks.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Albert Einstein College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically documented uterine leiomyosarcoma with no visible residual disease
• Surgical staging to include total hysterectomy, +/- removal of ovaries and fallopian tubes, +/- lymph node sampling
• Patients must be entered no more than 12 weeks post operatively
• Eastern Cooperative Oncology Group (ECOG) performance status of < 2
• Written voluntary informed consent

Exclusion Criteria:

• Serum glutamic oxaloacetic transaminase (SGOT) and /or serum glutamate pyruvate transaminase (SGPT) > 2.5 times the institutional upper limit of normal
• Total serum bilirubin > 1.5 mg/dl
• History of chronic or active hepatitis
• Serum creatinine > 2.0 mg/dl
• Platelets < 100,000/mm3
• Absolute neutrophil count (ANC) < 1500/mm3
• Hemoglobin < 8.0 g/dl (the patient may be transfused prior to study entry)
• Patients with severe or uncontrolled concurrent medical disease (eg. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
• Patients with any prior chemotherapy or radiotherapy for pelvic malignancy
• Patients who have had prior therapy with gemcitabine or docetaxel
• Patients with known hypersensitivity to gemcitabine or docetaxel
• Patients with known hypersensitivity to pegfilgrastim and filgrastim
• Patients with any history of cancer with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the past five years
• Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment (gemcitabine, docetaxel, brachytherapy/IMRT, EBRT); CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or IMRT over 3 weeks. Patients then undergo EBRT QD 5 days a week for 5 weeks.

Other: Laboratory Biomarker Analysis; Correlative studies; Drug: Docetaxel; Given IV; Other Names: TXT; Drug: Gemcitabine Hydrochloride; Given IV; Other Names: dFdCyd; Difluorodeoxycytidine (dFdC); Radiation: External Beam Radiation Therapy; Undergo EBRT; Other Names: EBRT; Definitive Radiation Therapy; External Beam RT; Radiation: Intensity-Modulated Radiation Therapy; Undergo IMRT; Other Names: IMRT; Intensity Modulated RT; Intensity-Modulated Radiotherapy; Radiation: Internal Radiation Therapy; Undergo brachytherapy; Other Names: Internal Radiation; Internal Radiation Brachytherapy; Radiation Brachytherapy; Brachytherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence-free Survival	Two-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution. In the event of censoring before two years, a Kaplan-Meier estimate of the survival probability will be used and a Kaplan-Meier survival curve will be estimated and presented as well. The study was terminated prior to analyses	Date of entry to date of reappearance of disease, assessed at 2 years. The study was terminated prior to analyses

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Akiva Novetsky, MD, Albert Einstein College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2013
• Primary Completion (Actual): February 24, 2017
• Study Completion (Actual): February 24, 2017

Study Registration Dates

• First Submitted: October 7, 2013
• First Submitted That Met QC Criteria: October 7, 2013
• First Posted (Estimated): October 9, 2013

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Muscle Tissue; Sarcoma; Leiomyosarcoma; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Gemcitabine
• Other Study ID Numbers: 13-03-096 (Other Identifier: Albert Einstein College of Medicine); P30CA013330 (U.S. NIH Grant/Contract); 13-014; NCI-2013-01364 (Registry Identifier: CTRP (Clinical Trial Reporting Program))