Status:
TERMINATED
Maintenance Treatment for Ovarian Carcinoma in Remission by an Antiangiogenic Treatment Strategy
Lead Sponsor:
HaEmek Medical Center, Israel
Conditions:
Ovarian Carcinoma
Eligibility:
FEMALE
20-80 years
Phase:
PHASE2
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01175772
Start Date
August 1 2010
End Date
April 1 2013
Last Update
June 23 2015
Active Locations (1)
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1
HaEmek Medical Center
Afula, Israel, 18101