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

Stopped early · Phase 2

Conditions studied: Advanced Endometrial Adenocarcinoma, Stage III A, B, C

In brief

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.

Key facts

Study ID

NCT00285415

Run by

Carilion Clinic

People needed

46

Starts

2005-04-01

Expected to finish

2012-06-01

Last updated by the study team

2021-02-05

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Gynecologic Oncology Research & Development, LLC — Greenville, South Carolina, United States
• Carilion GYN Oncology Associates — Roanoke, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.