drugset / Trial / NCT01175772

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

NCT01175772 ↗

Phase 2 Terminated 6 enrolled HaEmek Medical Center, Israel
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2010-08
Primary completion
2013-04
Completion
2013-04

Outcome

Outcome not reported

Stopped: “Due to change in the national policy of medications”

Drugs

EvaluationDrugModalityDoseRoute
Subject Celecoxib Other / unclassified 200 mg Oral
Subject Cyclophosphamide Other / unclassified 50 mg Oral
Subject Methotrexate Small molecule 2.5 mg Oral

Indications