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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00052312 |
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether doxorubicin and cisplatin are more effective with or without paclitaxel in treating endometrial cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of combining doxorubicin and cisplatin with or without paclitaxel in treating patients who have locally advanced, metastatic, and/or relapsed endometrial cancer.
Condition | Intervention | Phase |
---|---|---|
Endometrial Cancer |
Drug: cisplatin Drug: doxorubicin hydrochloride Drug: paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | Randomized Trial Of Adriamycin (A) Cisplatin (P) Chemotherapy Versus Paclitaxel (T) Adriamycin (A) And Cisplatin (P) In Patients With Metastatic/Relapsed Or Locally Advanced Inoperable Endometrial Cancer |
Estimated Enrollment: | 312 |
Study Start Date: | September 2002 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to performance status (0 vs 1 vs 2), metastatic disease (M0 vs M1), prior pelvic radiotherapy for pelvic recurrence (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. In the event of progressive disease, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed endometrial epithelial carcinoma meeting at least 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Investigator: | Nicholas S. Reed, MD | University of Glasgow |
Investigator: | Giorgio Bolis, MD | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
Study ID Numbers: | CDR0000258154, EORTC-55984 |
Study First Received: | January 24, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00052312 History of Changes |
Health Authority: | United States: Federal Government |
recurrent endometrial carcinoma stage III endometrial carcinoma stage IV endometrial carcinoma endometrial papillary carcinoma |
Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Endometrial Cancer Antimitotic Agents Recurrence Doxorubicin Carcinoma Genital Diseases, Female |
Anti-Bacterial Agents Endometrial Neoplasms Radiation-Sensitizing Agents Cisplatin Paclitaxel Tubulin Modulators Carcinoma, Papillary Uterine Neoplasms Antineoplastic Agents, Phytogenic |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Antimitotic Agents Antibiotics, Antineoplastic Pharmacologic Actions Doxorubicin |
Genital Diseases, Female Endometrial Neoplasms Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Cisplatin Paclitaxel Therapeutic Uses Tubulin Modulators Uterine Neoplasms Antineoplastic Agents, Phytogenic |