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

NCT01958580 | Terminated Results DMC

• 4 other identifiers: 13-03-096NCI-2013-0136413-014P30CA013330
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment (gemcitabine, docetaxel, brachytherapy/IMRT, EBRT)

EXPERIMENTAL

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.

Drug: Gemcitabine Hydrochloride; Drug: Docetaxel; Radiation: Internal Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Radiation: External Beam Radiation Therapy; Other: Laboratory Biomarker Analysis

Interventions

Gemcitabine Hydrochloride DRUG

Given IV

Also known as: Difluorodeoxycytidine (dFdC), dFdCyd

Treatment (gemcitabine, docetaxel, brachytherapy/IMRT, EBRT)

Docetaxel DRUG

Given IV

Also known as: TXT

Treatment (gemcitabine, docetaxel, brachytherapy/IMRT, EBRT)

Internal Radiation Therapy RADIATION

Undergo brachytherapy

Also known as: Brachytherapy, Internal Radiation, Internal Radiation Brachytherapy, Radiation Brachytherapy

Treatment (gemcitabine, docetaxel, brachytherapy/IMRT, EBRT)

Intensity-Modulated Radiation Therapy RADIATION

Undergo IMRT

Also known as: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy

Treatment (gemcitabine, docetaxel, brachytherapy/IMRT, EBRT)

External Beam Radiation Therapy RADIATION

Undergo EBRT

Also known as: Definitive Radiation Therapy, EBRT, External Beam RT

Treatment (gemcitabine, docetaxel, brachytherapy/IMRT, EBRT)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (gemcitabine, docetaxel, brachytherapy/IMRT, EBRT)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Interventions

Gemcitabine; Docetaxel; Brachytherapy; Radiotherapy, Intensity-Modulated

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; Radiotherapy; Therapeutics; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted

Results Point of Contact

• Title: Dr. Jessica Atrio - Professor, Department of Obstetrics & Gynecology and Women's Health
• Organization: Albert Einstein College of Medicine - Montefiore Medical center

jatrio@montefiore.org

917-721-6155

Study Officials

• Akiva Novetsky, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 9, 2013
• Study Start: September 17, 2013
• Primary Completion: February 24, 2017
• Study Completion: February 24, 2017
• Last Updated: August 16, 2023
• Results First Posted: August 16, 2023

Record last verified: 2023-07

Locations

US (1)