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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00016341 |
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 | Intervention | Phase |
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Endometrial Cancer |
Drug: cisplatin Drug: doxorubicin hydrochloride Drug: filgrastim Drug: megestrol acetate Drug: paclitaxel Drug: tamoxifen citrate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
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 |
OBJECTIVES:
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.
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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Measurable disease
At least one lesion accurately measured in at least one dimension
Estrogen receptor(ER)/progesterone receptor (PR) status of primary tumor required
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Jeffrey D. Bloss, MD | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
Study ID Numbers: | CDR0000068624, GOG-0189 |
Study First Received: | May 6, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00016341 |
Health Authority: | United States: Federal Government |
stage III endometrial carcinoma stage IV endometrial carcinoma recurrent endometrial carcinoma |
Citric Acid Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Tamoxifen Megestrol Recurrence Doxorubicin |
Carcinoma Genital Diseases, Female Endometrial Neoplasms Cisplatin Paclitaxel Uterine Neoplasms Endometrial cancer Megestrol Acetate |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Contraceptive Agents Hormone Antagonists Physiological Effects of Drugs Contraceptives, Oral Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Reproductive Control Agents Antibiotics, Antineoplastic Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Neoplasms by Site |
Therapeutic Uses Contraceptives, Oral, Synthetic Appetite Stimulants Estrogen Antagonists Antineoplastic Agents, Hormonal Mitosis Modulators Central Nervous System Stimulants Antimitotic Agents Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Tubulin Modulators Antineoplastic Agents, Phytogenic Central Nervous System Agents |