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A Phase II Study of Therapy With Paclitaxel, Carboplatin and Megesterol Acetate for the Management of Uterine Cancer
This study is ongoing, but not recruiting participants.
Sponsored by: University of Alabama at Birmingham
Information provided by: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00584857
  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 II

MedlinePlus related topics: Cancer Uterine Cancer
Drug Information available for: Megestrol acetate Megestrol Carboplatin Paclitaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

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

Primary Outcome Measures:
  • To determine the overall survival in patients with advanced stage or recurrent endometrial cancer treated with the combination of paclitaxel, carboplatin and megesterol acetate. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the toxicity in patients with advanced stage or recurrent endometrial cancer treated with the combination of paclitaxel, carboplatin and megesterol acetate. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: July 2004
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
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 Highlands, 1201 11th Ave S, 4th Floor, Gynecologic Oncology
Birmingham, Alabama, United States, 35205
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: John M. Straughn, MD University of Alabama at Birmingham
  More Information

Responsible Party: UAB ( J. Michael Straughn, M.D, Assistant Professor Department of OB/GYN, Division of GYN Oncology )
Study ID Numbers: F040628007, UAB 403
Study First Received: December 21, 2007
Last Updated: September 11, 2008
ClinicalTrials.gov Identifier: NCT00584857  
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
Endometrial cancer
Megestrol
Megestrol Acetate
Recurrence
Carcinoma

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