Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01367301
Recruitment Status : Unknown
Verified January 2015 by Merieme Klobocista, Albert Einstein College of Medicine.
Recruitment status was:  Recruiting
First Posted : June 7, 2011
Last Update Posted : January 19, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Merieme Klobocista, Albert Einstein College of Medicine

Tracking Information
First Submitted Date  ICMJE June 3, 2011
First Posted Date  ICMJE June 7, 2011
Last Update Posted Date January 19, 2015
Study Start Date  ICMJE May 2011
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2014)
Recurrence-free survival [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2011)
Recurrence-free survival [ Time Frame: 2 years ]
Recurrence-free survival is defined as date of entry to date of reappearance of disease. Site(s) and date of relapse will be recorded. Recurrent disease will be defined as pelvic or distant. Pelvic sites will be specified as vaginal or other, and distant sites will be specified as to their anatomic location. Relapse should be confirmed by histologic or cytologic evaluation when possible.
Change History Complete list of historical versions of study NCT01367301 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2011)
Toxicity [ Time Frame: 2 years ]
Toxicities will be graded according to the NCI Common Toxicity Criteria (version 4). Myelosuppressive toxicity will be reported as the lowest observed white blood and platelet counts. Anemia and red blood cell transfusions will be noted. Gastrointestinal toxicities will be reported and hospitalizations for nausea,vomiting and diarrhea will be documented. Patients will be followed for potential long-term toxicities with complete histories and physical examinations. Any patient who receives at least one course of therapy and has follow-up information will be included for observation of toxicity.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With Uterine Cancer
Official Title  ICMJE A Pilot Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With Uterine Carcinosarcoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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 Name: 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 Name: IMRT
  • Other: laboratory biomarker analysis
    Correlative studies
Study Arms  ICMJE 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.

Interventions:
  • Drug: paclitaxel
  • Drug: carboplatin
  • Radiation: external beam radiation therapy
  • Radiation: brachytherapy
  • Radiation: intensity-modulated radiation therapy
  • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 6, 2011)
18
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01367301
Other Study ID Numbers  ICMJE 11-02-064
NCI-2013-01225 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
10-089
11-02-064 ( Other Identifier: Albert Einstein College of Medicine )
P30CA013330 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merieme Klobocista, Albert Einstein College of Medicine
Study Sponsor  ICMJE Albert Einstein College of Medicine
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Merieme Klobocista Albert Einstein College of Medicine
PRS Account Albert Einstein College of Medicine
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP