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Sponsors and Collaborators: |
Yale University Novartis |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00703807 |
Endometrial cancer is the most common malignancy of the female reproductive tract. The majority of patients with endometrial cancer are diagnosed at an early stage and cured with surgery with or without adjuvant radiotherapy. However, a significant number of patients present with metastatic disease outside of the pelvis or develop recurrent disease after primary therapy.
mTOR inhibitors have been shown to be promising agents in reducing tumor growth in vitro and in vivo, in several solid cancers. Inhibitors of mTOR are primarily cytostatic in cancer cells; combination therapy with cytotoxic chemotherapeutics and other biologic agents may prove to be the most advantageous use of these drugs. mTOR inhibition with a rapamycin analogue demonstrated in vitro antiproliferative activity on endometrial AN3 CA and HEC-1-A tumor cells, and this inhibition of proliferation was found to be concentration dependent. Topotecan is an active agent in the treatment of advanced and recurrent endometrial cancers.
Condition | Intervention | Phase |
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Endometrial Cancer |
Drug: Topotecan Drug: RAD001 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Study of the Weekly Oral RAD001 in Combination With Oral Topotecan in Patients With Advanced or Recurrent Endometrial Cancers |
Estimated Enrollment: | 36 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Daily oral RAD001 for 21 days in combination with oral topotecan on days 1-5 of a 21 day cycle
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Drug: Topotecan
Dose escalation, 5 dose levels, 1.5 mg/m2 - 2.3 mg/m2, PO day 1-5 every 21 days
Drug: RAD001
Dose level -1, 5 mg qod Dose level 1, 5 mg qod Dose level 2, 5 mg qd Dose level 3, 5 mg qd DOse level 4, 10 mg qd
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Martha Luther, RN | 203-737-2781 | martha.luther@yale.edu |
Contact: Lisa Baker, RN | 203-737-2781 | lisa.baker@yale.edu |
United States, Connecticut | |
Yale University School of Medicine | Recruiting |
New Haven, Connecticut, United States, 06520 | |
Principal Investigator: Maysa Abu-Khalaf, M.D. |
Principal Investigator: | Maysa Abu-Khalaf, M.D. | Yale University |
Responsible Party: | Yale University School of Medicine ( Maysa Abu-Khalaf, M.D. ) |
Study ID Numbers: | 0804003747 |
Study First Received: | June 20, 2008 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00703807 |
Health Authority: | United States: Food and Drug Administration |
Everolimus Genital Diseases, Female Endometrial Neoplasms Genital Neoplasms, Female Uterine Diseases |
Uterine Neoplasms Urogenital Neoplasms Endometrial cancer Topotecan Recurrence |
Neoplasms Neoplasms by Site Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions |