Maintenance Treatment for Ovarian Carcinoma in Remission by an Antiangiogenic Treatment Strategy
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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) |
- 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
|
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations| 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 |
| 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. | |
| 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 June 13, 2013