Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00415207
Other study ID # WRAMC WU# 04-23009
Secondary ID
Status Completed
Phase N/A
First received December 21, 2006
Last updated August 4, 2011
Start date December 2006
Est. completion date December 2010

Study information

Verified date December 2006
Source University of Southern Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial Summary

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 retrospectively in patients who participated in clinical trials that are now closed. All patients had ovarian cancer and received paclitaxel/carboplatin chemotherapy after primary surgery.


Description:

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 will use tissue from patients who participated in one of two clinical trials that are both closed for inclusion. Genotypic data from this tissue will be correlated with toxicity and survival data drawn from a research database. We expect to be able to find >300 available cases to study.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date December 2010
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients enrolled in "TC/TEC" in Denmark, Sweden or Norway

- Patients enrolled in "OVAR-9" in Denmark, Sweden or Norway

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Clinical Pharmacology, University of Southern Denmark Odense

Sponsors (3)

Lead Sponsor Collaborator
University of Southern Denmark Danish Clinical Intervention Research Academy, Ministry of the Interior and Health, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Bergmann TK, Gréen H, Brasch-Andersen C, Mirza MR, Herrstedt J, Hølund B, du Bois A, Damkier P, Vach W, Brosen K, Peterson C. Retrospective study of the impact of pharmacogenetic variants on paclitaxel toxicity and survival in patients with ovarian cancer — View Citation

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03371693 - Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer Phase 3
Active, not recruiting NCT03648489 - Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma) Phase 2
Active, not recruiting NCT02950064 - A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations Phase 1
Completed NCT02569983 - The SOCQER-2 Study Surgery in Ovarian Cancer - Quality of Life Evaluation Research
Terminated NCT02055690 - PAZOFOS: Phase Ib and Phase II Trial of Pazopanib +/- Fosbretabulin in Advanced Recurrent Ovarian Cancer Phase 1/Phase 2
Withdrawn NCT02243059 - Magnetic Resonance Imaging for Lymph Node Staging in Ovarian Cancer Phase 4
Completed NCT01719926 - Phase I Platinum Based Chemotherapy Plus Indomethacin Phase 1
Completed NCT00243685 - Chemotherapy Drug Sensitivity Microculture (MiCK) Assay for Apoptosis Phase 2/Phase 3
Completed NCT00415181 - Pharmacogenomics of Paclitaxel in Ovarian Cancer N/A
Recruiting NCT01789229 - Establishment of a Tumor Bank for Tissue Samples
Completed NCT00069160 - Tariquidar and Docetaxel to Treat Patients With Lung, Ovarian, Renal and Cervical Cancer Phase 2
Completed NCT00772863 - Efficacy and Safety of Subsequent Cisplatin and Docetaxel in Ovarian Cancer Phase 2
Completed NCT00046800 - Study of OSI-211 vs. Topotecan in Patients With Relapsed Epithelial Ovarian Cancer Phase 2
Completed NCT00035100 - EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer Phase 2
Terminated NCT00034372 - Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-Chemotherapy Consolidation for Ovarian Carcinoma Phase 2
Completed NCT00001272 - A Phase I Study of Taxol, Cisplatin, Cyclophosphamide and Granulocyte Colony-Stimulating Factor (G-CSF) in Previously Nontreated Ovarian Cancer Patients Phase 1
Recruiting NCT05007106 - MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) Phase 2
Recruiting NCT05001282 - A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRĪ±) Phase 1/Phase 2
Completed NCT02227654 - Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors N/A
Not yet recruiting NCT04055038 - Efficacy of Platinum-based Chemotherapy in Platinum-resistant Ovarian Cancer) (EPITOC) Phase 2/Phase 3