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

Sponsor
Albert Einstein College of Medicine (Other)
Overall Status
Terminated
CT.gov ID
NCT01958580
Collaborator
National Cancer Institute (NCI) (NIH)
3
Enrollment
1
Location
1
Arm
41
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Gemcitabine Hydrochloride
  • Drug: Docetaxel
  • Radiation: Internal Radiation Therapy
  • Radiation: Intensity-Modulated Radiation Therapy
  • Radiation: External Beam Radiation Therapy
  • Other: Laboratory Biomarker Analysis
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:
  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Safety and Toxicity Trial of Adjuvant Chemotherapy With Gemcitabine and Docetaxel and Radiation Therapy for Completely Resected Uterine Leiomyosarcoma
Actual Study Start Date :
Sep 1, 2013
Actual Primary Completion Date :
Sep 1, 2014
Actual Study Completion Date :
Feb 1, 2017

Arms and Interventions

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.

Drug: Gemcitabine Hydrochloride
Given IV
Other Names:
  • dFdC
  • dFdCyd

    • Drug: Docetaxel
    Given IV
    Other Names:
  • TXT

    • Radiation: Internal Radiation Therapy
    Undergo brachytherapy
    Other Names:
  • Brachytherapy
  • Internal Radiation
  • Internal Radiation Brachytherapy
  • Radiation Brachytherapy

    • Radiation: Intensity-Modulated Radiation Therapy
    Undergo IMRT
    Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy

    • Radiation: External Beam Radiation Therapy
    Undergo EBRT
    Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam RT

    • Other: Laboratory Biomarker Analysis
    Correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. Recurrence-free survival [Date of entry to date of reappearance of disease, assessed at 2 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Albert Einstein College of Medicine Bronx New York United States 10461

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Akiva Novetsky, MD, Albert Einstein College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Albert Einstein College of Medicine
    ClinicalTrials.gov Identifier:
    NCT01958580
    Other Study ID Numbers:
    • 13-03-096
    • NCI-2013-01364
    • 13-014
    • 13-03-096
    • P30CA013330
    First Posted:
    Oct 9, 2013
    Last Update Posted:
    Dec 12, 2019
    Last Verified:
    Dec 1, 2019
    Additional relevant MeSH terms:
    Sarcoma
    Leiomyosarcoma
    Gemcitabine
    Docetaxel

    Study Results

    No Results Posted as of Dec 12, 2019