Status:
TERMINATED
A Phase II Evaluation of Docetaxel and Carboplatin Followed by Tumor Volume Directed Pelvic Irradiation
Lead Sponsor:
Carilion Clinic
Collaborating Sponsors:
Sanofi
Conditions:
Advanced Endometrial Adenocarcinoma, Stage III A, B, C
Eligibility:
FEMALE
18-99 years
Phase:
PHASE2
Brief 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 trea...
Detailed Description
Endometrial carcinoma is the most common malignancy in the female reproductive tract. For the percentage of patients with advanced stage (III - IV) optimum adjuvant therapy status-post surgical stagin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00285415
Start Date
April 1 2005
End Date
June 1 2012
Last Update
February 5 2021
Active Locations (2)
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1
Gynecologic Oncology Research & Development, LLC
Greenville, South Carolina, United States, 29601
2
Carilion GYN Oncology Associates
Roanoke, Virginia, United States, 24014