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
Conditions
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.
Interventions
DRUGpaclitaxel
Given IV
DRUGcarboplatin
Given IV
RADIATIONexternal beam radiation therapy
Undergo external beam radiation therapy
RADIATIONbrachytherapy
Undergo HDR brachytherapy
RADIATIONintensity-modulated radiation therapy
Undergo IMRT
OTHERlaboratory biomarker analysis
Correlative studies
Sponsors
National Cancer Institute (NCI)
Albert Einstein College of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-free Survival | 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. |
Countries
United States
Participant flow
Recruitment details
14 participants were enrolled into the study between 7/08/2011-3/8/2016. Three participants screen failed prior to consenting.
Participants by arm
| Arm | Count |
|---|---|
| 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.
paclitaxel: Given IV
carboplatin: Given IV
external beam radiation therapy: Undergo external beam radiation therapy
brachytherapy: Undergo HDR brachytherapy
intensity-modulated radiation therapy: Undergo IMRT
laboratory biomarker analysis: Correlative studies | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Treatment (Paclitaxel, Carboplatin, Radiotherapy) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 2 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
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.
Time frame: Date of entry to date of reappearance of disease, assessed at 1 year
Population: Recurrence-free survival data was not collected/aggregated and therefore not analyzed.