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

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ClinicalTrials.gov Identifier: NCT01367301
Recruitment Status : Unknown
Verified January 2015 by Merieme Klobocista, Albert Einstein College of Medicine, Inc..
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, Inc.

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
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 Drug: paclitaxel Drug: carboplatin Radiation: external beam radiation therapy Radiation: brachytherapy Radiation: intensity-modulated radiation therapy Other: laboratory biomarker analysis Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
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 2011
Estimated Primary Completion Date : January 2016


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 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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367301


Locations
United States, New York
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Merieme Klobocista    718-405-8082    mkloboci@montefiore.org   
Principal Investigator: Merieme Klobocista         
Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
National Cancer Institute (NCI)
Investigators
Principal Investigator: Merieme Klobocista Albert Einstein College of Medicine, Inc.

Responsible Party: Merieme Klobocista, Principal Investigator, Albert Einstein College of Medicine, Inc.
ClinicalTrials.gov Identifier: NCT01367301     History of Changes
Other Study ID Numbers: 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 )
First Posted: June 7, 2011    Key Record Dates
Last Update Posted: January 19, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Sarcoma
Carcinosarcoma
Mixed Tumor, Mullerian
Uterine Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Complex and Mixed
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action