Clinical Trials Logo
  1. Home
  2. Endometrial Adenocarcinoma
  3. NCT01041027

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 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01041027
Study type Interventional
Source Albert Einstein College of Medicine
Contact
Status Terminated
Phase Phase 2
Start date January 16, 2009
Completion date October 1, 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT01935973 - Trametinib With or Without GSK2141795 in Treating Patients With Recurrent or Persistent Endometrial Cancer Phase 1
Active, not recruiting NCT03660826 - Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone Phase 2
Active, not recruiting NCT04106414 - Study of BMS-986205 and Nivolumab in Endometrial Cancer or Endometrial Carcinosarcoma That Has Not Responded to Treatment Phase 2
Completed NCT01642082 - Dalantercept in Treating Patients With Recurrent or Persistent Endometrial Cancer Phase 2
Completed NCT01208467 - Prognostic Biomarkers in Patients With Endometrial Cancer N/A
Completed NCT01011933 - Selumetinib in Treating Patients With Recurrent or Persistent Endometrial Cancer Phase 2
Completed NCT00025467 - Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer Phase 2
Completed NCT01440998 - Dasatinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer Phase 1
Completed NCT00006089 - Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer Phase 2
Active, not recruiting NCT00977574 - Paclitaxel, Carboplatin, and Bevacizumab or Paclitaxel, Carboplatin, and Temsirolimus or Ixabepilone, Carboplatin, and Bevacizumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer Phase 2
Recruiting NCT05001282 - A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRĪ±) Phase 1/Phase 2
Completed NCT01968317 - Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma Phase 2
Completed NCT01225887 - Nintedanib in Treating Patients With Recurrent or Persistent Endometrial Cancer Phase 2
Completed NCT01005329 - Intensity-Modulated Radiation Therapy, Cisplatin, and Bevacizumab Followed by Carboplatin and Paclitaxel in Treating Patients Who Have Undergone Surgery for Endometrial Cancer Phase 2
Active, not recruiting NCT02208375 - mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian Phase 1/Phase 2
Completed NCT03716414 - Evaluation of the Efficacy for Sentinel Lymph Node Policy in High-risk Endometrial Carcinoma
Withdrawn NCT03836157 - Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer Phase 2
Completed NCT00095979 - Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer Phase 2
Completed NCT00072176 - Temsirolimus in Treating Patients With Metastatic or Locally Advanced Recurrent Endometrial Cancer Phase 2
Active, not recruiting NCT03460483 - Universal Endometrial Cancer DNA Sequencing for Detection of Lynch Syndrome and Personalized Care N/A