A Phase 2 interventional study of Cytophosphan, Celecoxib, Methotrexate in Ovarian Carcinoma, sponsored by HaEmek Medical Center, Israel. Terminated at 1 site in Israel. Open to female participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-06-23.
Sponsored by HaEmek Medical Center, Israel · Phase 2, Interventional, and Treatment
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.
6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.
This study's enrollment of 6 is below the median of 45 across 5,174 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →HaEmek Medical Center, Israel is the lead sponsor of 228 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Maintenance Treatment for Ovary Carcinoma by Metronomic Chemotherapy
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
Time to Progression
Median time to progression of the cohort will be compared with equivalent measure in the literature.
Time frame: 18 months
This study is terminated, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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HaEmek Medical Center, Israel