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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)


Phase 2
20 Years
80 Years
Open (Enrolling)
Female
Ovarian Carcinoma

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Trial Information

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)


Inclusion Criteria:



1. Histologic proof of papillary-serous ovarian cancer or 1ary peritoneal
carcinomatosis.

2. Histological grade III.

3. Original disease in stage III.

4. ECOG performance status: 0-2.

5. Age: 20-80 years.

6. Previous chemotherapy with paclitaxel and carboplatin (only).

7. Previous cyto-reductive surgery.

8. Clinical Complete Response (both physically and by imaging).

9. CA 125 should be either normalized (in at least 50 patients) or while still in
decreasing values at monthly measurements.

10. CBC at normal values or with any toxicity at a grade limited to I by NCIC-CTC.

11. Liver and renal functions < 1.5 upper normal limits (UNL) by SMA.

12. The patient's signature on the informed consent.

Exclusion Criteria:

1. Mucinous type ovarian carcinoma.

2. Histological Grade I-II.

3. Current continuous treatment by steroids or by NSAIDs, or by anti-coagulants for "non
protocol" reasons.

4. Previous history of active peptic ulcer.

5. Current participation in any other treatment study.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Progression

Outcome Description:

Median time to progression of the cohort will be compared with equivalent measure in the literature.

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

David Loven, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

HaEmek Medical Center, Oncology Unit

Authority:

Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:

0082-09-EMC

NCT ID:

NCT01175772

Start Date:

August 2010

Completion Date:

August 2013

Related Keywords:

  • Ovarian Carcinoma
  • Ovary
  • Carcinoma
  • Maintenance
  • Metronomic
  • Chemotherapy
  • Time to Progression
  • overall survival
  • Carcinoma
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

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