Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Endometrial Cancer

Endometrial Adenocarcinoma Clinical Trial

Official title:

A Pilot Phase II Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With High-Risk Endometrial Cancer After Standard Surgical Staging

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01041027
• Other study ID #: 08-03-060
• Secondary ID: NCI-2013-0122407
• Status: Terminated
• Phase: Phase 2
• Start date: January 16, 2009
• Est. completion date: October 1, 2019

Study information

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

Clinical Trial Summary

This phase II trial studies how well radiation therapy, paclitaxel, and carboplatin work in treating patients with high-risk endometrial 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, by stopping them from dividing or by stopping them from spreading. Giving radiation therapy with chemotherapy may kill more tumor cells.

Description:

PRIMARY OBJECTIVES: I. To evaluate progression-free survival. II. To assess and document location of disease recurrence (distant vs local vs both) using this treatment regimen. II. To evaluate the toxicity of radiation therapy "sandwiched" between cycles of paclitaxel/carboplatin chemotherapy in patients with high-risk endometrial cancer. III. To evaluate the associations of cancer recurrence with tumor tissue expression levels of insulin-like growth factor-I (IGF-I), IGF-II, insulin-like growth factor binding protein 1 (IGFBP-1) and -3, insulin receptor, IGF-I receptor, estrogen receptor, and progesterone receptor. OUTLINE: CHEMOTHERAPY (weeks 1-9, 13-21): 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 3 courses during weeks 13-21. RADIATION THERAPY (weeks 8-13 or 8-15): Patients with stage I disease undergo high dose rate (HDR) brachytherapy once weekly for a total of 5 fractions during weeks 8-13. All other patients undergo external beam radiation therapy (EBRT) once daily (QD) 5 days a week for a total of 25 fractions during weeks 8-12 and HDR brachytherapy once weekly for a total of 3 fractions during weeks 13-15. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically-documented high-risk endometrioid adenocarcinoma with no visible

residual disease, defined by the following criteria:

• Surgical stage I disease with < 50 myometrial invasion and grade 3 tumor (IAG3) with lymphovascular space involvement;
• Surgical stage I disease with >= 50% myometrial invasion and grade 2 or 3 tumor (IBG2, IBG3);
• Any surgical stage II disease (II);
• Any surgical stage III disease (IIIA, IIIB, IIIC); and
• Any surgical stage IV disease with no residual macroscopic tumor
• Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings as per standard Gynecologic Oncology Group (GOG) criteria
• 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/mm^3
• Absolute neutrophil count (ANC) < 1500/mm^3
• 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 dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry
• 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

Related Conditions & MeSH terms

• Endometrial Adenocarcinoma
• Endometrial Neoplasms
• Stage IA Uterine Corpus Cancer
• Stage IB Uterine Corpus Cancer
• Stage II Uterine Corpus Cancer
• Stage IIIA Uterine Corpus Cancer
• Stage IIIB Uterine Corpus Cancer
• Stage IIIC Uterine Corpus Cancer
• Stage IVA Uterine Corpus Cancer
• Stage IVB Uterine Corpus Cancer

Intervention

Drug:
• Paclitaxel
Given IV
• Carboplatin
Given IV

Radiation:
• Internal Radiation Therapy
Undergo HDR brachytherapy
• External Beam Radiation Therapy
Undergo EBRT

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	Progression-free Survival (PFS)	PFS will be analyzed using standard survival analytic methods, including the Kaplan-Meier approach for estimating the survival distribution. Median time to progression and 95% confidence intervals will be estimated from the Kaplan-Meier curves.	From randomization until documented tumor recurrence or death from any cause, assessed up to 5 years
Secondary	Expression Levels of IGF-1	Associations of PFS with tumor tissue expression levels of IGF-1 will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.	Up to 5 years
Secondary	Expression Levels of IGF-2	Associations of PFS with tumor tissue expression levels of IGF-2 will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.	Up to 5 years
Secondary	Expression Levels of IGFBP-1	Associations of PFS with tumor tissue expression levels of IGFBP-1 will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.	Up to 5 years
Secondary	Expression Levels of IGFBP-3	Associations of PFS with tumor tissue expression levels of IGFBP-3 will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.	Up to 5 years
Secondary	Expression Levels of Insulin Receptor	Associations of PFS with tumor tissue expression levels of insulin receptor will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.	Up to 5 years
Secondary	Expression Levels of IGF-1 Receptor	Associations of PFS with tumor tissue expression levels of IGF-1 receptor will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.	Up to 5 years
Secondary	Expression Levels of Estrogen Receptor	Associations of PFS with tumor tissue expression levels of estrogen receptor will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.	Up to 5 years
Secondary	Expression Levels of Progesterone Receptor	Associations of PFS with tumor tissue expression levels of progesterone receptor will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.	Up to 5 years