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Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With Uterine Cancer

Sponsor
Albert Einstein College of Medicine (Other)
Overall Status
Terminated
CT.gov ID
NCT01367301
Collaborator
National Cancer Institute (NCI) (NIH)
12
Enrollment
1
Location
1
Arm
100
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This pilot clinical trial studies radiation therapy, paclitaxel, and carboplatin in treating patients with uterine cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Giving radiation with chemotherapy may kill more tumor cells.

Condition or Disease Intervention/Treatment Phase
  • Drug: paclitaxel
  • Drug: carboplatin
  • Radiation: external beam radiation therapy
  • Radiation: brachytherapy
  • Radiation: intensity-modulated radiation therapy
  • Other: laboratory biomarker analysis
 N/A

Detailed Description

PRIMARY OBJECTIVES:

  1. To assess the one year recurrence-free survival in patients with uterine carcinosarcoma treated with "sandwich" therapy-including defining the patterns of recurrence in patients with carcinosarcoma who were treated with this regimen.

  2. To evaluate the toxicity and tolerability of pelvic radiation "sandwiched" between cycles of paclitaxel/carboplatin chemotherapy in patients with uterine carcinosarcoma.

  3. To correlate surrogate endpoint biomarkers with progression-free survival and prognosis.

OUTLINE:

CHEMOTHERAPY (weeks 1-9, 14-22): Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 14-22.

RADIATION THERAPY (weeks 8-16): Patients undergo external beam pelvic radiation therapy once a day, 5 days a week for 5 weeks during weeks 8-13. Patients then undergo high dose radiation (HDR) brachytherapy or intensity-modulated radiation therapy (IMRT) once weekly during weeks 14-16.

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 :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With Uterine Carcinosarcoma
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Sep 1, 2019
Actual Study Completion Date :
Sep 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (paclitaxel, carboplatin, radiotherapy)

CHEMOTHERAPY (weeks 1-9, 14-22): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 14-22. RADIATION THERAPY (weeks 8-16): Patients undergo external beam pelvic radiation therapy once a day, 5 days a week for 5 weeks during weeks 8-13. Patients then undergo HDR brachytherapy or IMRT once weekly during weeks 14-16.

Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol

    • Drug: carboplatin
    Given IV
    Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin

    • Radiation: external beam radiation therapy
    Undergo external beam radiation therapy
    Other Names:
  • EBRT

    • Radiation: brachytherapy
    Undergo HDR brachytherapy
    Other Names:
  • low-LET implant therapy
  • radiation brachytherapy
  • therapy, low-LET implant

    • Radiation: intensity-modulated radiation therapy
    Undergo IMRT
    Other Names:
  • IMRT

    • 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 1 year]

      One-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically documented uterine carcinosarcoma with no visible residual disease

    • Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings

    • 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)

    • Patient has severe or uncontrolled concurrent medical disease (e.g. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)

    • Patient with any prior chemotherapy or radiotherapy for pelvic malignancy

    • 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: Merieme Klobocista, Albert Einstein College of Medicine
    • Principal Investigator: Dennis Yi-Shin Kuo, Montefiore Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Albert Einstein College of Medicine
    ClinicalTrials.gov Identifier:
    NCT01367301
    Other Study ID Numbers:
    • 11-02-064
    • NCI-2013-01225
    • 10-089
    • 11-02-064
    • P30CA013330
    First Posted:
    Jun 7, 2011
    Last Update Posted:
    Apr 22, 2021
    Last Verified:
    Apr 1, 2021
    Additional relevant MeSH terms:
    Sarcoma
    Carcinosarcoma
    Mixed Tumor, Mullerian
    Uterine Neoplasms
    Paclitaxel
    Carboplatin

    Study Results

    No Results Posted as of Apr 22, 2021