A Phase II Study of Paclitaxel and Carboplatin in Patients With an Elevated-Risk Cancer of the Uterus
Stopped early · Phase 2
Conditions studied: Uterine Cancer
In brief
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.
Key facts
- Study ID
- NCT00584909
- Run by
- University of Alabama at Birmingham
- People needed
- 13
- Starts
- 2006-03-01
- Expected to finish
- 2011-09-01
- Last updated by the study team
- 2017-01-27
Who can join
Age: 19 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- Platelets >/= 100,000/µ
- Granulocytes (ANC)>/= 1,500/µl
- Creatinine</= 1.6 mg/dl
- SGOT (AST) </= 3x upper limits of normal
- 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.
You may not qualify if…
- 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.
Where it is running
- UAB Women's and Infant Center, 1700 6th Avenue South — Birmingham, Alabama, 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.