Clinical trial · Interventional
A Phase II Study of Paclitaxel and Carboplatin in Patients With an Elevated-Risk Cancer of the Uterus
A Phase II Study of Paclitaxel and Carboplatin in Patients With Intermediate-Risk Adenocarcinoma of the Endometrium
NCT00584909CI-TRIAL-00025654terminatedPhase 2Results postedClinicalTrials.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): low accrual
Summary
Brief summary (as posted)
The main purpose of this study us to determine the best treatment for patients with endometrial cancer who are at an elevated risk for recurrence.
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 |
|---|---|---|---|
| Uterine Cancer | Malignant Uterine Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel and carboplatin combination | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Open Label
- interventionNames
- Drug: Paclitaxel and carboplatin combination
Primary outcomes (1)
- measure
- Disease-free Survival
- timeFrame
- 4 years - Median follow up time of 45.3 months
- description
- Number of months of survival with no evidence of disease
Secondary outcomes (1)
- measure
- Toxicity
- timeFrame
- 4 years
- description
- Toxicity secondary to paclitaxel and carboplatin based upon the NCI common toxicity criteria version
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a elevated risk, surgical stage II, stage IC, grade 2 or 3 adenocarcinoma of the endometrium. * Patients must have undergone, a total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and a pelvic and para-aortic lymphadenectomy. * Patients must have adequate organ function defined as: 1. Platelets \>/= 100,000/µ 2. Granulocytes (ANC)\>/= 1,500/µl 3. Creatinine\</= 1.6 mg/dl 4. SGOT (AST) \</= 3x upper limits of normal 5. Bilirubin within institutional normal limits * Patients must have adequate performance status (ECOG performance status 0-2 or Karnofsky Performance Status \>40) * Patients must be age 19 or greater and have signed informed consent. Exclusion Criteria: * Patients with history of other malignancies within 5 years (except non- melanoma skin cancer or carcinoma-in-situ of the cervix) are ineligible. * Patients with high-risk histologic subtypes of endometrial cancer such as papillary serous or clear cell histology are ineligible. * Patients with histologic evidence of uterine sarcoma, including leiomyosarcoma, carcinosarcoma, endometrial stromal sarcoma, and adenosarcoma are ineligible. * Patients who have received past pelvic radiotherapy are ineligible. * Patients receiving any other investigational agents are ineligible. * Patients with known hypersensitivity to paclitaxel and/or carboplatin are ineligible.
References
Publications (0)
Data not yet available
No reference posted for this study.