NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

TerminatedPhase 2

Sponsor: Carilion Clinic

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

Interventions: Docetaxel and Carboplatin

Countries: United States

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (2)

Greenville, South Carolina, United States
Roanoke, Virginia, United States