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

Phase 2

Completed

Interventions: Drug: carboplatin
Drug: docetaxel
Radiation: radiation therapy

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.

Recruitment & Eligibility

Inclusion Criteria

Histologically confirmed endometrial cancer
Advanced or recurrent disease
- Stage IIIB or IIIC disease
  - Stage IIIA disease allowed provided there is serosal involvement or direct extension or metastasis to the adnexa
  - No stage IIIA confirmed by only positive peritoneal washings
- Stage IVA or IVB disease
Failed local therapy or considered incurable with local therapy
Measurable or evaluable disease
- Not required for newly diagnosed stage III or IV disease with no remaining disease after surgery
Performance status Gynecology Oncology Group (GOG) 0-1
Life expectancy at least 12 weeks
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 10 g/dL
Meets 1 of the following criteria:
- Alkaline phosphatase (AP) normal AND aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 5 times upper limit of normal (ULN)
- AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
- AP ≤ 5 times ULN AND AST or ALT normal
Bilirubin normal
No acute hepatitis
Creatinine ≤ 1.5 mg/dL

Exclusion Criteria

Known hypersensitivity to docetaxel or polysorbate 80
Severe infection
Septicemia
Pregnant or nursing
Positive pregnancy test
Fertile patients must use effective nonhormonal contraception during and for at least 3 months after study treatment
Peripheral neuropathy ≥ grade 2
Severe gastrointestinal bleeding requiring a blood transfusion or hospitalization
Other malignancy within the past 5 years except nonmetastatic, nonmelanoma skin cancer or carcinoma in situ of the cervix
Prior chemotherapy
Prior radiotherapy

Arm && Interventions

Group	Intervention	Description
Patients with Endometrial Cancer	radiation therapy	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).
Patients with Endometrial Cancer	carboplatin	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).
Patients with Endometrial Cancer	docetaxel	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).

Primary Outcome Measures

Name	Time	Method
Percent of Patients Estimated to be Progression-Free and Alive	1 Year, 2 Years, 3 Years	This estimate was determined by using a statistical method of analysis (Kaplan-Meier).

Secondary Outcome Measures

Name	Time	Method
Percent of Patients Estimated to be Alive	1 Year, 2 Years, 3 Years	This estimate of overall survival was determined by using the statistical method (Kaplan-Meier) of analysis.

Locations (2): Masonic Cancer Center, University of Minnesota
🇺🇸
Minneapolis, Minnesota, United States
Park Nicollet Cancer Center
🇺🇸
Saint Louis Park, Minnesota, United States