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Sponsors and Collaborators: |
University of Southern Denmark Danish Clinical Intervention Research Academy Ministry of the Interior and Health, Denmark |
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Information provided by: | University of Southern Denmark |
ClinicalTrials.gov Identifier: | NCT00415181 |
This study will try to determine whether or not certain genes are responsible for the huge variation in toxicity and effect observed between patients treated with paclitaxel (chemotherapeutic drug). Specifically we will study this in patients with ovarian cancer who receive paclitaxel/carboplatin chemotherapy after primary surgery.
Condition |
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Ovarian Neoplasms Fallopian Tube Neoplasms |
Study Type: | Observational |
Study Design: | Screening, Longitudinal, Defined Population, Prospective Study |
Official Title: | The Pharmacogenomics of Paclitaxel in Patients With Ovarian Cancer: Predictors of Toxicity and Response |
Estimated Enrollment: | 100 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | March 2013 |
Paclitaxel is an antineoplastic drug used in the treatment of ovarian cancer. The effect and toxicity is unpredictable in the individual patient. Paclitaxel is removed (eliminated) from the organism by oxidation. CYP2C8 is the enzyme mainly responsible. P-glycoprotein (Pgp) is an efflux transport protein natural to the human organism. Pgp is responsible for excretion of drugs via the bile and the kidneys and is thought to play a role in chemotherapy resistance. Paclitaxel is substrate for Pgp. Single nucleotide polymorphisms are possible causes for variation in both CYP2C8 and Pgp expression/function. We will study a possible role of these genetic variations as predictors of paclitaxel toxicity and effect and the possible implications for individual dosing in the future.
We want to determine the metabolic capacity of approximately 100 ovarian cancer patients and comparing this with genotypes, acute toxicity(eg. bone marrow suppression and neuropathy) and response to treatment(ie. CA125 response, progression free survival and overall survival). The metabolic capacity is estimated using a “sparse sampling” approach applying advanced computerized pharmacokinetic/dynamic modelling as opposed to traditional “frequent sampling” pharmacokinetic studies which burden the individual patient more.
Patients are recruited in collaboration with Oncological departments throughout Scandinavia.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Troels K Bergmann, MD | +45 61704711 | placebo@halian.dk |
Denmark | |
Department of Oncology, Odense University Hospital | Recruiting |
Odense, Denmark | |
Department of Oncology, Vejle Hospital | Recruiting |
Vejle, Denmark | |
Department of oncology, Herlev Hospital | Recruiting |
Herlev, Denmark | |
Sweden | |
Department of Oncology, University Hospital of Lund | Recruiting |
Lund, Sweden |
Study Director: | Kim Brøsen, phd | University of Southern Denmark |
Study ID Numbers: | AKF-319pro |
Study First Received: | December 21, 2006 |
Last Updated: | December 21, 2006 |
ClinicalTrials.gov Identifier: | NCT00415181 |
Health Authority: | Denmark: Danish Dataprotection Agency |
CYP2C8 MDR1 Pharmacogenetics Paclitaxel |
Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases |
Fallopian Tube Neoplasms Fallopian Tube Diseases Genital Diseases, Female Paclitaxel Fallopian tube cancer Endocrinopathy Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Mitosis Modulators |
Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions Adnexal Diseases |