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A Phase II Study of Therapy With Paclitaxel, Carboplatin and Megesterol Acetate for the Management of Uterine Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
J. Michael Straughn, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00584857
First received: December 21, 2007
Last updated: February 28, 2012
Last verified: January 2012
History of Changes
  Purpose

This is a study to determine the optimal treatment for patients with advanced stage or recurrent endometrial cancer. Traditionally, patients have been treated with either hormonal therapies (megesterol) or chemotherapy (paclitaxel and carboplatin). This study investigates the effectiveness of the combination of hormonal therapy and chemotherapy. This study also will examine the side-effects associated with these drugs and the quality of life of patients on combination therapy.


Condition Intervention Phase
Uterine Cancer
 Drug: Paclitaxel ,Carboplatin , Megesterol Acetate
 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 Combination Therapy With Paclitaxel, Carboplatin and Megesterol Acetate for the Management of Advanced Stage or Recurrent Carcinoma of the Endometrium

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 3-year Overall Survival [ Time Frame: 3 years - median followup of 40.4 months ] [ Designated as safety issue: No ]
    Number of subjects alive at 3 years


Secondary Outcome Measures:
  • Toxicity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Toxicity secondary to paclitaxel, carboplatin, and megesterol acetate based on NCI common toxicity criteria


Enrollment: 30
Study Start Date: July 2004
Study Completion Date: October 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemotherapy
Single
 Drug: Paclitaxel ,Carboplatin , Megesterol Acetate
Paclitaxel will be administered at an appropriate dose (175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at an appropriate dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at an anti-tumor dosage of 40 mg. This will be given for a total of 6 cycles over 18 weeks with the Megace continuing for 5 years as long as no evidence of recurrence is present.

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  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have biopsy proven endometrioid adenocarcinoma or adenosquamous carcinoma.
  • Patients must have evidence of primary FIGO Stage III-IVB or recurrent endometrial cancer.
  • Patients with non-measurable disease following complete cytoreduction at the time of initial operative management for Stage III-IVB are eligible.

  • Patients with recurrent disease must have disease confirmed by one of the following:

    1. CT Scan
    2. MRI
    3. PET Scan
    4. Physical Exam

  • Patients must have adequate organ function defined as:

    1. Platelets >/= 100,000/1
    2. Granulocytes (ANC) >/= 1,500/
    3. Creatinine </= 1.6mg/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.
  • Patients must be age 19 or greater and have signed informed consent.

Exclusion Criteria:

  • Patients with history of other malignancies (except non-melanoma skin cancer or carcinoma-in-situ of the cervix) are ineligible.
  • Patients with high-risk histologic subtypes of endometrial cancer, namely papillary serous or clear cell histology are ineligible.
  • Patients with evidence of uterine sarcoma, including leiomyosarcoma, carcinosarcoma, endometrial stromal sarcoma, and adenosarcoma are ineligible.
  • Patients who are less than 8 weeks after the completion of radiotherapy are ineligible.
  • Patients receiving any other investigational agents are ineligible.
  • Patients with known hypersensitivity to paclitaxel, carboplatin, or megesterol are ineligible.
  • Patients with uncontrolled current illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, serious peripheral neuropathy, or psychiatric illness/social situations that would limit or preclude compliance with study requirements are ineligible.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584857

Locations
United States, Alabama
UAB Women's and Infant Center, 1700 6th Ave S
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: John M. Straughn, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: J. Michael Straughn, MD, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00584857     History of Changes
Other Study ID Numbers: F040628007 (UAB 0403), UAB 0403
Study First Received: December 21, 2007
Results First Received: September 23, 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 June 18, 2013