Clinical trial · Interventional
A Phase II Evaluation of Docetaxel and Carboplatin Followed by Tumor Volume Directed Pelvic Irradiation
A Phase II Evaluation of Docetaxel and Carboplatin Followed by Tumor Volume Directed Pelvic Plus or Minus Para-Aortic Irradiation for Stage III/IV Endometrial Carcinoma
NCT00285415CI-TRIAL-00049895terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Investigator abruptly left Carilion.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Endometrial Adenocarcinoma, Stage III A, B, C | Endometrial Adenocarcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel and Carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Doc and Car
- description
- Receiving Doc and Car
- interventionNames
- Drug: Docetaxel and Carboplatin
Primary outcomes (1)
- measure
- Overall response rate (ORR) for patients treated with docetaxel and carboplatin as measured by RECIST 1.1
- timeFrame
- every 3 months
- description
- to estimate the overall response rate (ORR) for women with newly diagnosed stages III-IV or recurrent endometrial carcinoma treated with docetaxel and carboplatin followed by tumor volume directed pelvic plus or minus para-aortic irradiation.
Secondary outcomes (3)
- measure
- Progressive free survival (PFS) for patients treated with docetaxel and carboplatin as measured by CA125.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.