Carboplatin, Docetaxel, and Radiation Therapy in Treating Patients With Stage III/IV, or Recurrent Endometrial Cancer
Endometrial Cancer
About this trial
This is an interventional treatment trial for Endometrial Cancer focused on measuring recurrent endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma
Eligibility Criteria
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
Sites / Locations
- Masonic Cancer Center, University of Minnesota
- Park Nicollet Cancer Center
Arms of the Study
Arm 1
Experimental
Patients with Endometrial Cancer
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).