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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:
ClinicalTrials.gov Identifier:
NCT00584909
First Posted: January 2, 2008
Last Update Posted: January 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
J. Michael Straughn, MD, University of Alabama at Birmingham
  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: Intervention Model: Single Group Assignment
Masking: None (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 J. Michael Straughn, MD, University of Alabama at Birmingham:

Primary Outcome Measures:
  • Disease-free Survival [ Time Frame: 4 years - Median follow up time of 45.3 months ]
    Number of months of survival with no evidence of disease


Secondary Outcome Measures:
  • Toxicity [ Time Frame: 4 years ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes 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:

    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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: UAB Department study number )
First Submitted: December 21, 2007
First Posted: January 2, 2008
Results First Submitted: September 21, 2011
Results First Posted: March 29, 2012
Last Update Posted: January 27, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action