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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00551070 |
RATIONALE: AZD6244 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects and how well AZD6244 works in treating patients with recurrent low-grade ovarian cancer.
Condition | Intervention | Phase |
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Ovarian Cancer |
Drug: MEK inhibitor AZD6244 Procedure: immunohistochemistry staining method Procedure: mutation analysis Procedure: pharmacological study Procedure: protein expression analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of AZD6244 (NSC #741078, IND #77782) in Women With Recurrent Low-Grade Serous Carcinoma of the Ovary |
Estimated Enrollment: | 51 |
Study Start Date: | December 2007 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral AZD6244 twice a day on days 1-28 in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection periodically for correlative and pharmacokinetic studies and to analyze AZD6244 peak concentrations and the corresponding peak time values. Previously collected archived tumor tissue samples are obtained to determine protein levels of p-ERK/ERKERK, DNA isolation and sequencing of BRAF and ras mutation analysis by immunohistochemistry (IHC).
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then once a year for 5 years.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meeting 1 of the following diagnosis:
PATIENT CHARACTERISTICS:
QTc interval ≤ 450 msec and no factors that increase the risk of QT prolongation or arrhythmic events including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Study Chair: | John H. Farley, MD | Walter Reed Army Medical Center |
Investigator: | David M. Gershenson, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000563965, GOG-0239 |
Study First Received: | October 22, 2007 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00551070 |
Health Authority: | United States: Food and Drug Administration |
borderline ovarian surface epithelial-stromal tumor ovarian serous cystadenocarcinoma recurrent borderline ovarian surface epithelial-stromal tumor |
Cystadenocarcinoma, Serous Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms |
Ovarian Diseases Ovarian epithelial cancer Recurrence Carcinoma Genital Diseases, Female Endocrinopathy Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Adnexal Diseases |