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

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. Identifier: NCT00584857
Recruitment Status : Completed
First Posted : January 2, 2008
Results First Posted : March 29, 2012
Last Update Posted : January 27, 2017
Information provided by (Responsible Party):
J. Michael Straughn, MD, University of Alabama at Birmingham

Brief Summary:
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 or disease Intervention/treatment Phase
Uterine Cancer Drug: Paclitaxel ,Carboplatin , Megesterol Acetate Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2004
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Uterine Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Chemotherapy
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.

Primary Outcome Measures :
  1. 3-year Overall Survival [ Time Frame: 3 years - median followup of 40.4 months ]
    Number of subjects alive at 3 years

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: 3 years ]
    Toxicity secondary to paclitaxel, carboplatin, and megesterol acetate based on NCI common toxicity criteria

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00584857

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
Principal Investigator: John M. Straughn, MD University of Alabama at Birmingham

Publications of Results:
Responsible Party: J. Michael Straughn, MD, Associate Professor, University of Alabama at Birmingham Identifier: NCT00584857     History of Changes
Other Study ID Numbers: F040628007 (UAB 0403)
UAB 0403 ( Other Identifier: University of Alabama at Birmingham )
First Posted: January 2, 2008    Key Record Dates
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
Uterine Diseases
Genital Diseases, Female
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action