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

Ovarian Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01175772
• Other study ID #: 0082-09-EMC
• Status: Terminated
• Phase: Phase 2
• First received: August 1, 2010
• Last updated: June 21, 2015
• Start date: August 2010
• Est. completion date: April 2013

Study information

• Verified date: June 2015
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Neoplasms, Glandular and Epithelial
• Ovarian Carcinoma
• Ovarian Neoplasms

Intervention

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

Locations

Country	Name	City	State
Israel	HaEmek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Progression	Median time to progression of the cohort will be compared with equivalent measure in the literature.	18 months	No