Carboplatin, Docetaxel, and Radiation Therapy in Treating Patients With Stage III/IV, or Recurrent Endometrial Cancer
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Intervention: carboplatin; docetaxel; radiation therapy
Intervention description: Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles.; 75 mg/m^2 on Day 1 of each course; Weekly, 5 days/week over 6-7 weeks (tailored 4500 cGy)
Intervention MeSH terms: Carboplatin; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent endometrial carcinoma; stage III endometrial carcinoma; stage IV endometrial carcinoma

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.
    

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