A Phase II Study of Paclitaxel and Carboplatin in Patients With an Elevated-Risk Cancer of the Uterus - Full Text View

Sponsored by:	University of Alabama at Birmingham
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00584909

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 II

MedlinePlus related topics: Cancer Uterine Cancer

Drug Information available for: Carboplatin Paclitaxel

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of Paclitaxel and Carboplatin in Patients With Intermediate-Risk Adenocarcinoma of the Endometrium

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

To determine disease-free survival in patients with surgical stage II or stage IC, grade 2 or 3 endometrial adenocarcinoma treated with the combination of paclitaxel and carboplatin. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the toxicity in patients with surgical stage II and stage IC, grade 2 or 3 endometrial carcinoma treated with the combination of paclitaxel and carboplatin. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	35
Study Start Date:	March 2006
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Open Label: Experimental	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).

Eligibility

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:
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584909

Contacts

Contact: Jolane H Gable, BSN

205-996-4662

Locations

United States, Alabama
UAB Highlands, 1201 11th Ave S, 4th Floor, Gynecologic Oncology	Recruiting
Birmingham, Alabama, United States, 35205
Contact: Patricia M Kilgore, RN 205-930-8648 pkilgore@uabmc.edu

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

Responsible Party:	UAB ( J. Michael Straughn, Jr., M.D. Assistant Professor,Dept of OB/GYN, Division of GYN Oncology )
Study ID Numbers:	F060328016, UAB 604
Study First Received:	December 21, 2007
Last Updated:	May 21, 2008
ClinicalTrials.gov Identifier:	NCT00584909
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Genital Diseases, Female
Paclitaxel
Genital Neoplasms, Female
Uterine Diseases

Uterine Neoplasms
Urogenital Neoplasms
Carboplatin
Adenocarcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009