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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by HaEmek Medical Center, Israel.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01175772
First received: August 1, 2010
Last updated: August 19, 2010
Last verified: August 2010
  Purpose

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 Intervention Phase
Ovarian Carcinoma
Drug: Cytophosphan, Celecoxib, Methotrexate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Time to Progression [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Median time to progression of the cohort will be compared with equivalent measure in the literature.


Estimated Enrollment: 60
Study Start Date: August 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175772

Contacts
Contact: Yehuda Ben David, M.D. 972-4-6494344 bendavid_ye@clalit.org.il
Contact: David Loven, M.D. 972-4-6495540 loven_da@clalit.org.il

Locations
Israel
HaEmek Medical Center Recruiting
Afula, Israel, 18101
Contact: Yehuda Ben David, M.D.    +972-4-6494331    bendavid_ye@clalit.org.il   
Contact: David Loven, M.D.    +972-4-6495540    loven_da@clalit.org.il   
Principal Investigator: Yehuda Ben David, M.D.         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Study Director: David Loven, M.D. HaEmek Medical Center, Oncology Unit
  More Information

No publications provided

Responsible Party: Dr. Yehuda Ben David, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01175772     History of Changes
Other Study ID Numbers: 0082-09-EMC
Study First Received: August 1, 2010
Last Updated: August 19, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by HaEmek Medical Center, Israel:
Ovary
Carcinoma
Maintenance
Metronomic
Chemotherapy
Time to Progression
overall survival

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Methotrexate
Celecoxib
Cyclophosphamide
Angiogenesis Inhibitors
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014