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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00016341 |
Purpose
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 |
|---|---|---|
|
Endometrial Cancer |
Biological: filgrastim Drug: cisplatin Drug: doxorubicin hydrochloride Drug: megestrol acetate Drug: paclitaxel Drug: tamoxifen citrate |
Phase III |
| Study Type: | Interventional |
| Study Design: | 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 |
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.
Eligibility| 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:
Contacts and Locations
Show 50 Study Locations| Study Chair: | Jeffrey D. Bloss, MD | Washington University Siteman Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00016341 History of Changes |
| Other Study ID Numbers: | CDR0000068624, GOG-0189 |
| Study First Received: | May 6, 2001 |
| Last Updated: | December 26, 2009 |
| Health Authority: | United States: Federal Government |
|
stage III endometrial carcinoma stage IV endometrial carcinoma recurrent endometrial carcinoma |
|
Endometrial Neoplasms Sarcoma, Endometrial Stromal Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors Cisplatin |
Doxorubicin Megestrol Acetate Megestrol Tamoxifen Paclitaxel Lenograstim Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Antineoplastic Agents, Hormonal Appetite Stimulants Central Nervous System Stimulants |