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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00390364 |
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 advanced or metastatic colorectal cancer that did not respond to previous therapy.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: everolimus Procedure: antiangiogenesis therapy Procedure: biopsy Procedure: diagnostic procedure Procedure: gene expression analysis Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: mutation analysis Procedure: protein tyrosine kinase inhibitor therapy Procedure: reverse transcriptase-polymerase chain reaction |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Single Agent RAD001 in Patients With Colon Cancer and Activating Mutations in the PI3KCA Gene |
Estimated Enrollment: | 37 |
Study Start Date: | October 2006 |
OBJECTIVES:
OUTLINE: This is an open-label study.
Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor biopsies and normal skin biopsies at baseline and after the first course of study treatment. Tumor tissue is examined for biological markers (e.g., epidermal growth factor receptor, ERK, Akt, p70s6k, p27, and Rb protein) by immunohistochemistry; apoptosis quantification by TUNEL assay; Ki-67 quantification and Ki-index; gene expression; and c-fos and p27 expression by reverse-transcriptase polymerase chain reaction.
PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Cytologically or pathologically confirmed colorectal adenocarcinoma
Refractory to ≥ 1 line of prior therapy
Tumor tissue available for genetic testing OR willing to undergo baseline tumor biopsy
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness, including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
No concurrent therapeutic anticoagulation
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 |
Principal Investigator: | Manuel Hidalgo, MD, PhD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000508071, JHOC-J05107, NOVARTIS-JHOC-J05107 |
Study First Received: | October 18, 2006 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00390364 |
Health Authority: | Unspecified |
adenocarcinoma of the colon adenocarcinoma of the rectum recurrent colon cancer stage III colon cancer |
stage IV colon cancer recurrent rectal cancer stage III rectal cancer stage IV rectal cancer |
Everolimus Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Recurrence |
Intestinal Neoplasms Rectal neoplasm Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Rectal cancer Colorectal Neoplasms |
Neoplasms Neoplasms by Site Immunologic Factors |
Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |