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| Sponsor: | European Organization for Research and Treatment of Cancer - EORTC |
|---|---|
| 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: | Masking: Open Label Primary Purpose: Treatment |
| 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 | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Italy | |
| Ospedale Mauriziano Umberto I | |
| Torino, Italy, 10128 | |
| Ospedale Civile | |
| Voghera (PV), Italy, 27058 | |
| Portugal | |
| Hospitais da Universidade de Coimbra (HUC) | |
| Coimbra, Portugal, 3049 | |
| Spain | |
| Hospital Universitasrio San Carlos | |
| Madrid, Spain, 28040 | |
| United Kingdom | |
| Queen Elizabeth Hospital | |
| Gateshead, England, United Kingdom, NE9 6SX | |
| Study Chair: | Gerald Gitsch, MD | Allgemeines Krankenhaus - Universitatskliniken |
More Information
| ClinicalTrials.gov Identifier: | NCT00022620 History of Changes |
| Other Study ID Numbers: | CDR0000068835, EORTC-55961 |
| Study First Received: | August 10, 2001 |
| Last Updated: | April 30, 2011 |
| Health Authority: | United States: Federal Government |
|
recurrent endometrial carcinoma endometrial papillary serous carcinoma |
|
Endometrial Neoplasms Sarcoma, Endometrial Stromal Cystadenocarcinoma, Serous 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 |
Cystadenocarcinoma Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Cystic, Mucinous, and Serous Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |