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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01175772
Recruitment Status : Terminated (Due to change in the national policy of medications)
First Posted : August 5, 2010
Last Update Posted : June 23, 2015
Information provided by (Responsible Party):
HaEmek Medical Center, Israel

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
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 : August 2010
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

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

Primary Outcome Measures :
  1. Time to Progression [ Time Frame: 18 months ]
    Median time to progression of the cohort will be compared with equivalent measure in the literature.

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01175772

HaEmek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Study Director: David Loven, M.D. HaEmek Medical Center, Oncology Unit

Responsible Party: HaEmek Medical Center, Israel Identifier: NCT01175772     History of Changes
Other Study ID Numbers: 0082-09-EMC
First Posted: August 5, 2010    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015

Keywords provided by HaEmek Medical Center, Israel:
Time to Progression
overall survival

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Angiogenesis Inhibitors
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents