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| Sponsor: | Association de Recherche sur les Cancers dont Gynecologiques at Hopital de l'Hotel Dieu |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00870337 |
Purpose
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or metastatic endometrial cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer |
Drug: everolimus |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Primary Purpose: Treatment |
| Official Title: | Phase II Multicenter Study Evaluating the Tolerability and Efficacy of RAD001 (Everolimus) in Patients With Relapsed or Metastatic Endometrial Cancer |
| Estimated Enrollment: | 44 |
| Study Start Date: | March 2008 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral everolimus daily in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed monthly for 3 months and then every 3 months thereafter.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the endometrium
PATIENT CHARACTERISTICS:
No concurrent serious and/or uncontrolled disease that would preclude study participation, including any of the following:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| France | |
| Hotel Dieu de Paris | |
| Paris, France, 75181 | |
| Principal Investigator: | Laure Chauvenet, MD | Hotel Dieu de Paris |
More Information
| ClinicalTrials.gov Identifier: | NCT00870337 History of Changes |
| Other Study ID Numbers: | CDR0000633321, ARCAGY-ENDORAD, NOVARTIS-ARCAGY-ENDORAD, ARCAGY-GINECO-EN101, INCA-RECF0512, EUDRACT-2007-003002-10 |
| Study First Received: | March 26, 2009 |
| Last Updated: | May 12, 2011 |
| Health Authority: | United States: Federal Government |
|
recurrent endometrial carcinoma stage IV endometrial carcinoma endometrial adenocarcinoma |
|
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 Everolimus Sirolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |