NCT00258362

Carboplatin, Docetaxel, and Radiation Therapy in Treating Patients With Stage III/IV, or Recurrent Endometrial Cancer

A Phase II Trial of Induction Carboplatin and Docetaxel Followed by Radiotherapy Then Consolidation Chemotherapy With Carboplatin and Docetaxel in Stage III, IV and Recurrent Endometrial Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving carboplatin and docetaxel followed by radiation therapy works in treating patients with stage III, stage IV, or recurrent endometrial cancer.

Detailed description

OBJECTIVES: Primary * Determine the time to progression in patients with stage III or IV or recurrent endometrial cancer treated with induction chemotherapy comprising carboplatin and docetaxel followed by radiotherapy and consolidation chemotherapy comprising carboplatin and docetaxel. Secondary * Determine the toxic effects of this regimen in these patients. * Determine the overall survival of patients treated with this regimen. OUTLINE: Patients receive docetaxel intravenous (IV) over 1 hour and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses. After hematologic recovery from chemotherapy, patients receive radiotherapy 5 days a week for up to 7 weeks. Beginning 3-4 weeks later, patients receive another 3 courses of docetaxel and carboplatin. After completion of study treatment, patients are followed periodically for 2 years.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	carboplatin	Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles.
DRUG	docetaxel	75 mg/m\^2 on Day 1 of each course
RADIATION	radiation therapy	Weekly, 5 days/week over 6-7 weeks (tailored 4500 cGy)

Timeline

• Start date: 2005-07-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2005-11-24
• Last updated: 2017-12-28
• Results posted: 2010-11-11

Locations

2 sites across 1 country: United States