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| Sponsor: | European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00022620 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have refractory or recurrent endometrial cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer |
Drug: paclitaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Study On Paclitaxel In Recurrent Uterine Papillary Serous Carcinoma (UPSC) |
| Study Start Date: | June 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 12 weeks.
PROJECTED ACCRUAL: Approximately 16-29 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed endometrial papillary carcinoma (uterine papillary serous carcinoma)
Platinum refractory disease, defined by one of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| Austria | |
| Allgemeines Krankenhaus der Stadt Wien | |
| Vienna, Austria, A-1090 | |
| Belgium | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| Italy | |
| Ospedale Civile | |
| Voghera (PV), Italy, 27058 | |
| Ospedale Mauriziano Umberto I | |
| Torino, Italy, 10128 | |
| Portugal | |
| Hospitais da Universidade de Coimbra (HUC) | |
| Coimbra, Portugal, 3049 | |
| Spain | |
| Hospital Universitasrio San Carlos | |
| Madrid, Spain, 28040 | |
| United Kingdom, England | |
| Queen Elizabeth Hospital | |
| Gateshead, England, United Kingdom, NE9 6SX | |
| Study Chair: | Gerald Gitsch, MD | Allgemeines Krankenhaus - Universitatskliniken |
More Information
| Study ID Numbers: | CDR0000068835, EORTC-55961 |
| Study First Received: | August 10, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00022620 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent endometrial carcinoma endometrial papillary carcinoma |
|
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Antimitotic Agents Pharmacologic Actions Genital Diseases, Female |
Endometrial Neoplasms Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Uterine Neoplasms Antineoplastic Agents, Phytogenic |