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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Collaborator: Sanofi
• Treatments: Carboplatin; Docetaxel

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