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Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial 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: NCT00016341
Recruitment Status : Terminated
First Posted : September 9, 2003
Last Update Posted : April 11, 2013
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group

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
Endometrial Cancer Biological: filgrastim Drug: cisplatin Drug: doxorubicin hydrochloride Drug: megestrol acetate Drug: paclitaxel Drug: tamoxifen citrate Phase 3

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
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 2001
Actual Primary Completion Date : October 2003

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • Not specified

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified


  • Platelet count at least 100,000/mm^3
  • Granulocyte count at least 1,500/mm^3


  • Bilirubin normal
  • SGPT no greater than 3 times upper limit of normal


  • Creatinine no greater than 1.6 mg/dL


  • 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


  • No history of pulmonary embolus


  • 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


Biologic therapy:

  • Prior biologic therapy allowed


  • No prior cytotoxic chemotherapy, including chemotherapy for radiosensitization

Endocrine therapy:

  • No prior hormonal therapy for endometrial cancer


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


  • See Disease Characteristics


  • Concurrent cardiac conduction-altering medications such as digitalis, beta blockers, or calcium channel blockers allowed at the investigator's discretion

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): NCT00016341

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Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
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Study Chair: Jeffrey D. Bloss, MD Washington University Siteman Cancer Center

Layout table for additonal information Identifier: NCT00016341    
Other Study ID Numbers: CDR0000068624
First Posted: September 9, 2003    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: June 2007
Keywords provided by Gynecologic Oncology Group:
stage III endometrial carcinoma
stage IV endometrial carcinoma
recurrent endometrial carcinoma
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Albumin-Bound Paclitaxel
Liposomal doxorubicin
Megestrol Acetate
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists