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Sponsored by: |
London Regional Cancer Program at London Health Sciences Centre |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00659568 |
RATIONALE: Metformin and temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of metformin when given together with temsirolimus in treating patients with metastatic or unresectable solid tumor or lymphoma.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Endometrial Cancer Kidney Cancer Lung Cancer Lymphoma Unspecified Adult Solid Tumor, Protocol Specific |
Drug: metformin hydrochloride Drug: temsirolimus |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | A Phase I Study of Temsirolimus in Combination With Metformin in Advanced Solid Tumours |
Estimated Enrollment: | 28 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of metformin hydrochloride.
Patients receive oral metformin once, twice, or three times daily on days 1-28 and temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy, including any of the following types:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Exclusion criteria:
Canada, Ontario | |
London Regional Cancer Program at London Health Sciences Centre | Recruiting |
London, Ontario, Canada, N6A 4L6 | |
Contact: Mary Mackenzie, MD 519-685-8615 |
Principal Investigator: | Mary Mackenzie, MD | London Regional Cancer Program at London Health Sciences Centre |
Study ID Numbers: | CDR0000593360, CAN-LRCC-UWOREB13877, WYETH-CAN-LRCC-UWOREB13877 |
Study First Received: | April 15, 2008 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00659568 History of Changes |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific stage III renal cell cancer stage IV renal cell cancer recurrent renal cell cancer recurrent endometrial carcinoma stage III endometrial carcinoma stage IV endometrial carcinoma recurrent breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer recurrent small cell lung cancer extensive stage small cell lung cancer stage III adult Burkitt lymphoma |
stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult Hodgkin lymphoma stage III adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage III adult T-cell leukemia/lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III mantle cell lymphoma stage III marginal zone lymphoma stage III small lymphocytic lymphoma stage IV adult Burkitt lymphoma |
Thoracic Neoplasms Lymphoma, Mantle-Cell Mantle Cell Lymphoma Urogenital Neoplasms Urologic Neoplasms Follicular Lymphoma Mycoses Endometrial Neoplasms Hypoglycemic Agents Leukemia, Lymphocytic, Chronic, B-Cell Lung Neoplasms Lymphoma, Large-Cell, Anaplastic Kidney Diseases Hodgkin Disease Breast Diseases |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Genital Neoplasms, Female Breast Neoplasms Carcinoma Carcinoma, Small Cell Waldenstrom Macroglobulinemia B-cell Lymphomas Lung Diseases Leukemia, T-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous Neoplasms, Glandular and Epithelial Urinary Tract Neoplasm Lymphoma, Follicular |
Thoracic Neoplasms Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Genital Diseases, Female Endometrial Neoplasms Hypoglycemic Agents Neoplasms by Site Urologic Diseases Respiratory Tract Diseases Lung Neoplasms Kidney Neoplasms Uterine Neoplasms Kidney Diseases Lymphoma |
Breast Diseases Respiratory Tract Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Skin Diseases Metformin Genital Neoplasms, Female Uterine Diseases Breast Neoplasms Pharmacologic Actions Carcinoma Lymphatic Diseases Neoplasms Lung Diseases |