NCT01041027

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Endometrial Adenocarcinoma
• 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

Interventions

Type	Name	Description
DRUG	Paclitaxel	Given IV
DRUG	Carboplatin	Given IV
RADIATION	Internal Radiation Therapy	Undergo HDR brachytherapy
RADIATION	External Beam Radiation Therapy	Undergo EBRT
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2009-01-16
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2009-12-30
• Last updated: 2023-10-26
• Results posted: 2023-10-26

Locations

1 site across 1 country: United States