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

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

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.

Study Overview

• Status: Terminated
• Conditions: Uterine Carcinosarcoma; 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; Stage IA Uterine Sarcoma; Stage IB Uterine Sarcoma; Stage IC Uterine Sarcoma
• Intervention / Treatment: Other: laboratory biomarker analysis; Drug: paclitaxel; Radiation: intensity-modulated radiation therapy; Drug: carboplatin; Radiation: external beam radiation therapy; Radiation: brachytherapy

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
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Albert Einstein College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

Other: laboratory biomarker analysis; Correlative studies; Drug: paclitaxel; Given IV; Other Names: Anzatax; Asotax; Taxol (TAX); Radiation: intensity-modulated radiation therapy; Undergo IMRT; Other Names: IMRT; Drug: carboplatin; Given IV; Other Names: Carboplat; CBDCA; JM-8; Paraplatin; Paraplat; Radiation: external beam radiation therapy; Undergo external beam radiation therapy; Other Names: EBRT; Radiation: brachytherapy; Undergo HDR brachytherapy; Other Names: radiation brachytherapy; therapy, low-LET implant; low-Linear energy transfer (LET) implant therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Merieme Klobocista, Albert Einstein College of Medicine; Principal Investigator: Dennis Yi-Shin Kuo, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2011
• Primary Completion (Actual): August 15, 2018
• Study Completion (Actual): August 15, 2018

Study Registration Dates

• First Submitted: June 3, 2011
• First Submitted That Met QC Criteria: June 6, 2011
• First Posted (Estimated): June 7, 2011

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Uterine Diseases; Neoplasms, Complex and Mixed; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Sarcoma; Carcinosarcoma; Mixed Tumor, Mullerian; Uterine Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel
• Other Study ID Numbers: 11-02-064 (Other Identifier: Albert Einstein College of Medicine); P30CA013330 (U.S. NIH Grant/Contract); 10-089 (St Luke's Roosevelt); NCI-2013-01225 (Registry Identifier: CTRP (Clinical Trial Reporting Program))