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Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer

Sponsor
Gynecologic Oncology Group (Other)
Overall Status
Terminated
CT.gov ID
NCT00016341
Collaborator
National Cancer Institute (NCI) (NIH)
50
Locations

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Estrogen can stimulate the growth of tumor cells. Hormone therapy using tamoxifen and megestrol may fight endometrial cancer by blocking the absorption of estrogen. It is not yet known whether chemotherapy is more effective than hormone therapy in treating endometrial cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with that of hormone therapy in treating patients who have recurrent, stage III, or stage IV endometrial cancer.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

OBJECTIVES:

  • Compare the progression-free survival and response of patients with stage III or IV or recurrent endometrial cancer treated with doxorubicin, cisplatin, paclitaxel, and filgrastim (G-CSF) vs tamoxifen and megestrol.

  • Compare the survival of patients treated with these regimens.

  • Determine if progesterone receptor status provides information on whether patients are more likely to benefit from chemotherapy.

  • Compare the toxicity profiles of these treatment regimens in these patients.

  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, cross-over, multicenter study. Patients are stratified according to progesterone receptor status (negative vs positive). Patients are randomized to 1 of 2 treatment arms.

  • Arm I:Patients receive chemotherapy comprising doxorubicin IV over 15-30 minutes followed by cisplatin IV over 1 hour on day 1; paclitaxel IV over 3 hours on day 2; and filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing for 10 days. Chemotherapy repeats every 21 days for up to 7 courses in the absence of disease progression or unacceptable toxicity.

  • At time of disease progression, patients cross-over to hormonal therapy as in arm II.

  • Arm II: Patients receive hormonal therapy comprising oral megestrol twice daily on weeks 1-3 followed by oral tamoxifen twice daily on weeks 4-6. Hormonal therapy repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

At time of disease progression, if patients have not previously been enrolled on arm I, patients cross-over to receive chemotherapy as in arm I.

Quality of life is assessed at baseline, 6 weeks, time of progression, and then after 6 weeks on cross-over therapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 630 patients will be accrued for this study within 42 months.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Primary Purpose:
Treatment
Official Title:
Randomized Phase III Crossover Trial of Chemotherapy (Doxorubicin/Cisplatin/Paclitaxel and G-CSF) Versus Hormonal Therapy (Tamoxifen/Megestrol Acetate) in Patients With Stage III & IV or Recurrent Endometrial Cancer
Study Start Date :
May 1, 2001
Actual Primary Completion Date :
Oct 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Histologically confirmed primary stage III or IV or recurrent endometrial cancer

    • Poor curative potential with radiotherapy or surgery (alone or in combination)

    • Measurable disease

    • At least one lesion accurately measured in at least one dimension

    • At least 20 mm by conventional techniques, including palpation, x-ray, CT scan, or MRI OR

    • At least 10 mm by spiral CT scan

    • Disease in a previously irradiated field as sole site of measurable disease allowed only if clear progression after completion of radiotherapy

    • Estrogen receptor(ER)/progesterone receptor (PR) status of primary tumor required

    • ER/PR status of measurable tumor optional

    PATIENT CHARACTERISTICS:
    Age:
    • Not specified
    Performance status:
    • GOG 0-2
    Life expectancy:
    • Not specified
    Hematopoietic:

    • Platelet count at least 100,000/mm^3

    • Granulocyte count at least 1,500/mm^3

    Hepatic:

    • Bilirubin normal

    • SGPT no greater than 3 times upper limit of normal

    Renal:
    • Creatinine no greater than 1.6 mg/dL
    Cardiovascular:

    • LVEF at least 50%

    • No third-degree or complete heart block, unless pacemaker is in place

    • Other conduction abnormalities or cardiac dysfunction allowed at the investigator's discretion

    • No history of deep venous thrombosis

    • No uncontrolled angina

    Pulmonary:
    • No history of pulmonary embolus
    Other:

    • No other malignancy within the past 5 years except nonmelanoma skin cancer

    • No concurrent medical illness that would preclude study

    • No serious uncontrolled infection

    • No serious peripheral neuropathy

    • No circumstances that would preclude study compliance

    • No sensitivity to E. coli-derived drug preparations

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • Prior biologic therapy allowed
    Chemotherapy:
    • No prior cytotoxic chemotherapy, including chemotherapy for radiosensitization
    Endocrine therapy:
    • No prior hormonal therapy for endometrial cancer
    Radiotherapy:

    • See Disease Characteristics

    • At least 4 weeks since prior radiotherapy involving the whole pelvis or more than 50% of the spine

    Surgery:
    • See Disease Characteristics
    Other:
    • Concurrent cardiac conduction-altering medications such as digitalis, beta blockers, or calcium channel blockers allowed at the investigator's discretion

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Comprehensive Cancer Center Birmingham Alabama United States 35294-3300
    2 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
    3 Community Hospital of Los Gatos Los Gatos California United States 95032
    4 Chao Family Comprehensive Cancer Center Orange California United States 92868
    5 University of Colorado Cancer Center Denver Colorado United States 80010
    6 Walter Reed Army Medical Center Washington District of Columbia United States 20307-5000
    7 H. Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612-9497
    8 Rush-Presbyterian-St. Luke's Medical Center Chicago Illinois United States 60612
    9 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
    10 Indiana University Cancer Center Indianapolis Indiana United States 46202-5289
    11 Holden Comprehensive Cancer Center at The University of Iowa Iowa City Iowa United States 52242-1009
    12 Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky United States 40536-0084
    13 Tufts University School of Medicine Boston Massachusetts United States 02111
    14 University of Massachusetts Memorial Medical Center Worcester Massachusetts United States 01655
    15 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379
    16 University of Minnesota Cancer Center Minneapolis Minnesota United States 55455
    17 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
    18 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    19 Ellis Fischel Cancer Center - Columbia Columbia Missouri United States 65203
    20 Washington University School of Medicine Saint Louis Missouri United States 63110
    21 Cooper Hospital/University Medical Center Camden New Jersey United States 08103
    22 Cancer Center of Albany Medical Center Albany New York United States 12208
    23 State University of New York Health Science Center at Brooklyn Brooklyn New York United States 11203
    24 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
    25 Schneider Children's Hospital at North Shore Manhasset New York United States 11030
    26 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
    27 State University of New York Health Sciences Center - Stony Brook Stony Brook New York United States 11790-7775
    28 Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina United States 27599-7295
    29 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
    30 Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina United States 27157-1082
    31 Barrett Cancer Center, The University Hospital Cincinnati Ohio United States 45267-0502
    32 Ireland Cancer Center Cleveland Ohio United States 44106-5065
    33 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
    34 Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio United States 43210-1240
    35 University of Oklahoma College of Medicine Oklahoma City Oklahoma United States 73190
    36 Abington Memorial Hospital Abington Pennsylvania United States 19001
    37 Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    38 University of Pennsylvania Cancer Center Philadelphia Pennsylvania United States 19104-4283
    39 Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania United States 19107-5541
    40 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    41 Medical University of South Carolina Charleston South Carolina United States 29425-0721
    42 Brookview Research, Inc. Nashville Tennessee United States 37203
    43 Simmons Cancer Center - Dallas Dallas Texas United States 75235-9154
    44 M.D. Anderson CCOP Research Base Houston Texas United States 77030-4009
    45 University of Texas - MD Anderson Cancer Center Houston Texas United States 77030-4009
    46 Fletcher Allen Health Care - Medical Center Campus Burlington Vermont United States 05401
    47 Cancer Center at the University of Virginia Charlottesville Virginia United States 22908
    48 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109-1024
    49 Tacoma General Hospital Tacoma Washington United States 98405
    50 Tom Baker Cancer Center - Calgary Calgary Alberta Canada T2N 4N2

    Sponsors and Collaborators

    • Gynecologic Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Jeffrey D. Bloss, MD, Washington University Siteman Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00016341
    Other Study ID Numbers:
    • CDR0000068624
    • GOG-0189
    First Posted:
    Sep 9, 2003
    Last Update Posted:
    Apr 11, 2013
    Last Verified:
    Jun 1, 2007
    Keywords provided by , ,
    stage III endometrial carcinoma
    stage IV endometrial carcinoma
    recurrent endometrial carcinoma
    Additional relevant MeSH terms:
    Endometrial Neoplasms
    Tamoxifen
    Paclitaxel
    Doxorubicin
    Liposomal doxorubicin
    Megestrol
    Megestrol Acetate

    Study Results

    No Results Posted as of Apr 11, 2013