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

Uterine Carcinosarcoma Clinical Trial

Official title:

A Pilot Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With Uterine Carcinosarcoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01367301
• Other study ID #: 11-02-064
• Secondary ID: NCI-2013-0122510
• Status: Terminated
• Phase: N/A
• Start date: July 8, 2011
• Est. completion date: August 15, 2018

Study information

• Verified date: August 2023
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: August 15, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinosarcoma
• Mixed Tumor, Mullerian
• Sarcoma
• 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
• Uterine Neoplasms

Intervention

Drug:
• paclitaxel
Given IV
• carboplatin
Given IV

Radiation:
• external beam radiation therapy
Undergo external beam radiation therapy
• brachytherapy
Undergo HDR brachytherapy
• intensity-modulated radiation therapy
Undergo IMRT

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-free Survival	One-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution.	Date of entry to date of reappearance of disease, assessed at 1 year