Conditions: Endometrial Cancer
Keywords: recurrent endometrial carcinoma stage III endometrial carcinoma stage IV endometrial carcinoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 41
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Patients with advanced or current endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (Weekly, 5 days/week over 6-7 weeks, tailored 4500 cGy) and followed by 3 courses of consolidation docetaxel (75 mg/m\^2 on Day 1 of each course) /carboplatin (Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles).

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

Protocol document: