A Worldwide Phase III Clinical Trial Seeks U.S. Patients to Explore Investigational Drug P... (urope 26 sites areplanned and recruitmen...)

A Worldwide Phase III Clinical Trial Seeks U.S. Patients to Explore Investigational Drug Phenoxodiol

Date:8/30/2007

urope, 26 sites are planned and recruitment has commenced at UZ Leuven Gynaecological Oncology in Leuven, Belgium.

The trial is studying the safety and effectiveness of the drug phenoxodiol, which has not yet been approved for marketing by the FDA, when used in combination with weekly doses of the chemotherapy drug, carboplatin. The trial will consist of two double blind treatment arms. Patients in one trial arm will receive weekly carboplatin and phenoxodiol. Patients in the other trial arm will also receive weekly carboplatin, but a placebo will be substituted for phenoxodiol. Neither patients, nor their doctors will know to which trial arm the patients are randomized.

A change from receiving carboplatin (or cisplatin) every two to three weeks to a weekly carboplatin regimen has been reported to provide a tumor response in some patients with recurrent ovarian cancer.(1) In addition to learning more about the safety and efficacy of phenoxodiol, researchers will learn more about the efficacy of weekly carboplatin.

In laboratory studies using animal models of cancer and human cell lines, phenoxodiol was shown to reverse chemoresistance to standard chemotherapies, including platinum drugs, taxanes, gemcitabine, topotecan and doxorubicin. The ability of phenoxodiol to reverse multi-drug resistance is thought to be due to its disruption of several key targets specific to tumor cell biochemistry.

In a prior Phase II clinical trial, phenoxodiol was tested in combination with either cisplatin or paclitaxel. Twenty one patients with late stage ovarian cancer that had become refractory to platinum (cisplatin or carboplatin) and 19 patients that had become resistant to paclitaxel therapy, following multiple courses of chemotherapy, were treated with phenoxodiol and cisplatin or phenoxodiol and paclitaxel, respectively. The cisplatin (40 mg/m2) or paclitaxel (80 mg/m2) was administered weekly, and phenoxodiol was administered by intravenous infusion at
'/>"/>

0

GOOD

Page: 1 2 3 4 5 6
Related medicine technology :

1. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
2. Phase 3 Results for Dabigatran Etexilate, an Investigational Oral Anticoagulant, Presented Today at the XXIst Congress of the International Society on Thrombosis and Haemostasis
3. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
4. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
5. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
6. Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis
7. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
8. NexMed Announces Completion of Patient Enrollment in Two Pivotal Phase 3 Studies for Anti-Fungal Product
9. AM-Pharma Announces Positive Results of Phase IIa Clinical Trial with Alkaline Phosphatase For Ulcerative Colitis
10. Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery
11. Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery

Post Your Comments:

A Worldwide Phase III Clinical Trial Seeks U.S. Patients to Explore Investigational Drug P...(urope 26 sites areplanned and recruitmen...),Health