Ovarian Neoplasms Clinical Trial
Official title:
The Pharmacogenomics of Paclitaxel in Patients With Ovarian Cancer: Predictors of Toxicity and Response
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 |
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.
Status | Completed |
Enrollment | 93 |
Est. completion date | March 2013 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Clinical diagnose and histology of invasive epithelial ovarian/tuba or peritoneal cancer - FIGO stage IIb-IV any grade or FIGO Ia-IIa only grade 3 or clear cell carcinoma (any stage and grade) - Natural candidate for paclitaxel 175mg/m2 + Carboplatin (AUC=5-6) - Baseline CA125=70 AND/OR evaluable disease after RECIST (incl ultrasound) - 18 years or older - Caucasian (ie.parents and grandparents are Caucasian) - Performance status 2 or lower (after WHO/ECOG) Exclusion Criteria: - Prior malignant disease apart from cervical carcinoma in situ and basal cell carcinoma of the skin - Prior chemo / radiotherapy - Ongoing or imminent other chemotherapies - Pregnant or lactating - Fertile woman of childbearing potential not willing to use adequate contraception - Neurological symptoms (any kind) worse than CTCAE grade 1 - Active infection or other serious disease that could impair on treatment and/or follow-up |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Denmark | Department of oncology, Herlev Hospital | Herlev | |
Denmark | Department of Oncology, Odense University Hospital | Odense | |
Denmark | Department of Oncology, Vejle Hospital | Vejle | |
Sweden | Department of Oncology, University Hospital of Lund | Lund |
Lead Sponsor | Collaborator |
---|---|
University of Southern Denmark | Danish Clinical Intervention Research Academy, Ministry of the Interior and Health, Denmark |
Denmark, Sweden,
Bergmann TK, Brasch-Andersen C, Gréen H, Mirza M, Pedersen RS, Nielsen F, Skougaard K, Wihl J, Keldsen N, Damkier P, Friberg LE, Peterson C, Vach W, Karlsson MO, Brosen K. Impact of CYP2C8*3 on paclitaxel clearance: a population pharmacokinetic and pharma — View Citation
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
|
||
Withdrawn |
NCT02243059 -
Magnetic Resonance Imaging for Lymph Node Staging in Ovarian Cancer
|
Phase 4 | |
Terminated |
NCT02055690 -
PAZOFOS: Phase Ib and Phase II Trial of Pazopanib +/- Fosbretabulin in Advanced Recurrent Ovarian Cancer
|
Phase 1/Phase 2 | |
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 | |
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 | |
Completed |
NCT03193671 -
Evaluation and Implementation of New Biomarkers and Algorithms for Diagnosis of Ovarian Cysts/Tumors in the Pelvis
|
N/A |