Trial record 13 of 1270 for:
Uterine Cancer: Clinical Trials
A Phase II Study of Paclitaxel and Carboplatin in Patients With an Elevated-Risk Cancer of the Uterus
This study has been terminated.
(low accrual)
Sponsor:
University of Alabama at Birmingham
Information provided by (Responsible Party):
J. Michael Straughn, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00584909
First received: December 21, 2007
Last updated: February 28, 2012
Last verified: January 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Uterine Cancer |
Drug: Paclitaxel and carboplatin combination |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Paclitaxel and Carboplatin in Patients With Intermediate-Risk Adenocarcinoma of the Endometrium |
Resource links provided by NLM:
Further study details as provided by University of Alabama at Birmingham:
Primary Outcome Measures:
- Disease-free Survival [ Time Frame: 4 years - Median follow up time of 45.3 months ] [ Designated as safety issue: Yes ]Number of months of survival with no evidence of disease
Secondary Outcome Measures:
- Toxicity [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]Toxicity secondary to paclitaxel and carboplatin based upon the NCI common toxicity criteria version
| Enrollment: | 13 |
| Study Start Date: | March 2006 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Open Label |
Drug: Paclitaxel and carboplatin combination
Paclitaxel will be administered at an appropriate dose (175 mg/m2) as a 3-hour continuous IV infusion every 21 days. Carboplatin will be administered at an appropriate dose utilizing the Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate (GFR).
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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:
- 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.
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584909
Locations
| United States, Alabama | |
| UAB Women's and Infant Center, 1700 6th Avenue South | |
| Birmingham, Alabama, United States, 35233 | |
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
| Principal Investigator: | John M. Straughn, MD | Assistant Professor, Dept of OB/Gyn, Division of GYN Oncology |
More Information
No publications provided
| Responsible Party: | J. Michael Straughn, MD, Associate Professor, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT00584909 History of Changes |
| Other Study ID Numbers: | F060328016 (UAB 0604), UAB 0604 |
| Study First Received: | December 21, 2007 |
| Results First Received: | September 21, 2011 |
| Last Updated: | February 28, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female Carboplatin Paclitaxel |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 23, 2013