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

Sponsor

HaEmek Medical Center, Israel (Other)

Overall Status

Terminated

CT.gov ID

NCT01175772

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Carcinoma	Drug: Cytophosphan, Celecoxib, Methotrexate	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Metronomic Chemoterapy 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

Arm

Intervention/Treatment

Experimental: Metronomic Chemoterapy

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

Outcome Measures

Primary Outcome Measures

Time to Progression [18 months]
Median time to progression of the cohort will be compared with equivalent measure in the literature.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologic proof of papillary-serous ovarian cancer or 1ary peritoneal carcinomatosis.
Histological grade III.
Original disease in stage III.
ECOG performance status: 0-2.
Age: 20-80 years.
Previous chemotherapy with paclitaxel and carboplatin (only).
Previous cyto-reductive surgery.
Clinical Complete Response (both physically and by imaging).
CA 125 should be either normalized (in at least 50 patients) or while still in decreasing values at monthly measurements.
CBC at normal values or with any toxicity at a grade limited to I by NCIC-CTC.
Liver and renal functions < 1.5 upper normal limits (UNL) by SMA.
The patient's signature on the informed consent.

Exclusion Criteria:

Mucinous type ovarian carcinoma.
Histological Grade I-II.
Current continuous treatment by steroids or by NSAIDs, or by anti-coagulants for "non protocol" reasons.
Previous history of active peptic ulcer.
Current participation in any other treatment study.