NCT01175772

Maintenance Treatment for Ovarian Carcinoma in Remission by an Antiangiogenic Treatment Strategy

Maintenance Treatment for Ovarian Carcinoma in Remission by an Antiangiogenic Treatment Strategy With Metronomic/Oral Chemotherapy (Cytophosphan Combined With Low-dose Methotrexate)and COX-2 Inhibition (Celecoxib)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: HaEmek Medical Center, Israel · Academic / Other
• Sex: Female
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Preclinical studies showed that metronomic chemotherapy can induce tumor regression secondary to apoptosis of the tumor blood vessels. This effect was increased by combining metronomic chemotherapy with anti-angiogenic drugs. Metronomic chemotherapy has already proved clinical effects too, especially on patients with breast or prostate carcinoma. This study is aimed to test the efficacy of an experimental metronomic chemotherapy regimen in a cohort of patients with ovarian cancer. Patients will receive the proposed regimen as maintenance treatment following response induction by the conventional maximal tolerated dose (MTD) regimen of Carboplatin and Paclitaxel. Our regimen will include Cytophosphan combined with two agents which are expected to act as indirect angiogenic inhibitors: (a) celecoxib, as a selective COX-2 inhibitor and (b) low-dose Methotrexate, as successfully practiced for suppressing the inflammatory manifestations of rheumatoid arthritis. All components of our regimen will be administered orally and continuously for one year based on the hypothesis that its anti-angiogenic properties will be able to suppress the recovery of residual disease, thus extending the time to progression (TTP), and possibly the overall survival as well.

Conditions

• Ovarian Carcinoma

Interventions

Type	Name	Description
DRUG	Cytophosphan, Celecoxib, Methotrexate	Metronomic Chemotherapy as maintenance treatment for patients with Ovarian Cancer * Cytophosphan tab 50 mg -1x1 per day, continuous * Celecoxib tab 200 mg - 1x2 per day, continuous * Methotrexate tab 2.5 mg - 1x2 per day, 2 days weekly

Timeline

• Start date: 2010-08-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2010-08-05
• Last updated: 2015-06-23

Locations

1 site across 1 country: Israel