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

NCT ID: NCT01958580

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-17
• Study Completion Date: 2017-02-24

Brief Summary

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.

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.

Conditions

Stage IA Uterine Sarcoma; Stage IB Uterine Sarcoma; Stage IC Uterine Sarcoma; 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; Uterine Corpus Leiomyosarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Gemcitabine Hydrochloride

Intervention Type: DRUG

Given IV

Docetaxel

Intervention Type: DRUG

Given IV

Internal Radiation Therapy

Intervention Type: RADIATION

Undergo brachytherapy

Intensity-Modulated Radiation Therapy

Intervention Type: RADIATION

Undergo IMRT

External Beam Radiation Therapy

Intervention Type: RADIATION

Undergo EBRT

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Interventions

Gemcitabine Hydrochloride

Given IV

Intervention Type: DRUG

Docetaxel

Given IV

Intervention Type: DRUG

Internal Radiation Therapy

Undergo brachytherapy

Intervention Type: RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

Intervention Type: RADIATION

External Beam Radiation Therapy

Undergo EBRT

Intervention Type: RADIATION

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

Difluorodeoxycytidine (dFdC); dFdCyd; TXT; Brachytherapy; Internal Radiation; Internal Radiation Brachytherapy; Radiation Brachytherapy; IMRT; Intensity Modulated RT; Intensity-Modulated Radiotherapy; Definitive Radiation Therapy; EBRT; External Beam RT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Akiva Novetsky, MD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

Albert Einstein College of Medicine

The Bronx, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2013-01364

Identifier Type: REGISTRY

Identifier Source: secondary_id

13-014

Identifier Type: -

Identifier Source: secondary_id

13-03-096

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA013330

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-03-096

Identifier Type: -

Identifier Source: org_study_id