A Phase II Evaluation of Docetaxel and Carboplatin Followed by Tumor Volume Directed Pelvic Irradiation

• Status: Terminated
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine the effectiveness of the combination of the two drugs, docetaxel (Taxotere®) and carboplatin (Paraplatin®) followed by radiation directed at the tumor in treating your endometrial cancer.

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

Details

• Lead Sponsor: Carilion Clinic
• Collaborator: Sanofi
• Treatments: Carboplatin; Docetaxel

Criteria

Inclusion Criteria:

• All patients with advanced endometrial adenocarcinoma, stage III A, B, C and Stage IV confined to the pelvis, and recurrent disease limited to the pelvis.

• Surgical stage III and limited stage IV disease, including those patients with positive adnexa, tumor invading the serosa, positive and/or para-aortic nodes, pelvic metastases, positive pelvic washings or vaginal involvement.

• Histology must be adenocarcinoma, adenosquamous cell, squamous cell, clear cell or serous papillary carcinoma

• Status post surgical resection, including a hysterectomy and bilateral salpingo-oophorectomy within the past

• 6 weeks (Pelvic lymph node and para-aortic lymph node sampling are optional)

• Patients may be sub-optimally or optimally debulked (disease < 2 cm). Patients are eligible with measurable disease or evaluable

• disease. All positive para-aortic node patients must be further staged by chest CT scan. If chest CT scan is negative, patients are eligible.

• Patients who have met the pre-entry criteria including following lab findings:

• ANC > 1500, Platelet count > 100,000/mm3, Hemoglobin ≥ 8 mg/dl, Creatinine < 2.0 mg/dl.

• Total Bilirubin must be within normal limits. (WNL)

• AST or ALT and Alkaline Phosphatase must be within the range allowing for eligibility

• Patients who have signed an approved informed consent.

• GOG Performance Grade 0, 1, or 2.

• Women ≥ 18 years of age

Exclusion Criteria:

• Patients with Stage IV or recurrent disease outside of the pelvis.

• Patients who have had prior pelvic or abdominal radiation therapy.

• Patients with concomitant malignancy other than non-melanoma skin cancer.

• Patient with a prior malignancy who have been disease-free for < 5 years or who received prior chemotherapy or radiation therapy for that malignancy.

• Patients with a history of serious co-morbid illness that would preclude protocol therapy.

• Patients with an estimated survival of less than three months.

• Patients with parenchymal liver metastases.

• Patients who received prior chemotherapy excluding low-dose methotrexate for rheumatologic reasons.

• Histology consistent with uterine sarcomas, carcinosarcoma or leiomyosarcoma.

• Women with baseline peripheral neuropathy Grade ≥ 2.

• Women with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80.