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

Primary Purpose

Stage IA Uterine Sarcoma, Stage IB Uterine Sarcoma, Stage IC Uterine Sarcoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
paclitaxel
carboplatin
external beam radiation therapy
brachytherapy
intensity-modulated radiation therapy
laboratory biomarker analysis
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IA Uterine Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Albert Einstein College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (paclitaxel, carboplatin, radiotherapy)

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 3, 2011
Last Updated
August 15, 2023
Sponsor
Albert Einstein College of Medicine
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01367301
Brief Title
Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With Uterine Cancer
Official Title
A Pilot Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With Uterine Carcinosarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Lack of accrual. PI left the institution
Study Start Date
July 8, 2011 (Actual)
Primary Completion Date
August 15, 2018 (Actual)
Study Completion Date
August 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
Detailed Description
PRIMARY OBJECTIVES: I. 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. II. To evaluate the toxicity and tolerability of pelvic radiation "sandwiched" between cycles of paclitaxel/carboplatin chemotherapy in patients with uterine carcinosarcoma. III. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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 Carcinosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (paclitaxel, carboplatin, radiotherapy)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Other Intervention Name(s)
Anzatax, Asotax, Taxol (TAX)
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
carboplatin
Other Intervention Name(s)
Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
external beam radiation therapy
Other Intervention Name(s)
EBRT
Intervention Description
Undergo external beam radiation therapy
Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Other Intervention Name(s)
low-Linear energy transfer (LET) implant therapy, radiation brachytherapy, therapy, low-LET implant
Intervention Description
Undergo HDR brachytherapy
Intervention Type
Radiation
Intervention Name(s)
intensity-modulated radiation therapy
Other Intervention Name(s)
IMRT
Intervention Description
Undergo IMRT
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Recurrence-free Survival
Description
One-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution.
Time Frame
Date of entry to date of reappearance of disease, assessed at 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merieme Klobocista
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dennis Yi-Shin Kuo
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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