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:
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
  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:

    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014