Ovarian CarcinomaPhase 2NCT01175772
Maintenance Treatment for Ovarian Carcinoma in Remission by an Antiangiogenic Treatment Strategy
A Phase 2 study testing Cytophosphan, Celecoxib, Methotrexate in people with Ovarian Carcinoma, run by HaEmek Medical Center, Israel at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Ovarian Carcinoma
- What is being tested?
- Cytophosphan, Celecoxib, Methotrexate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2010to Apr 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Ovarian Carcinoma
- Being tested
- Cytophosphan, Celecoxib, Methotrexate
- Keywords
- Ovary, Carcinoma, Maintenance, Metronomic, Chemotherapy, Time to Progression, overall survival
- Medical subject headings
- Ovarian Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytophosphan, Celecoxib, MethotrexateDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Metronomic Chemoterapy | Experimental | Maintenance Treatment for Ovary Carcinoma by Metronomic Chemotherapy Receives: Drug: Cytophosphan, Celecoxib, Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Progression
Median time to progression of the cohort will be compared with equivalent measure in the literature.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: Due to change in the national policy of medications
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Loven, M.D., Study director, HaEmek Medical Center, Oncology Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175772
- Sponsor's protocol ID
- 0082-09-EMC
- Status last verified
- Jun 2015
- First submitted
- 1 Aug 2010
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01175772
- Acronym / sponsor ID
- 0082-09-EMC
- Conditions
- Ovarian Carcinoma
- Keywords
- Ovary, Carcinoma, Maintenance, Metronomic, Chemotherapy, Time to Progression, overall survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to change in the national policy of medications
- Enrolment
- 6 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 5 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metronomic Chemoterapy | Experimental | Drug: Cytophosphan, Celecoxib, MethotrexateMaintenance Treatment for Ovary Carcinoma by Metronomic Chemotherapy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytophosphan, Celecoxib, MethotrexateMetronomic 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 | Drug | Metronomic Chemoterapy |
Primary outcome
Time to Progression
Time frame: 18 months
Median time to progression of the cohort will be compared with equivalent measure in the literature.
Results and safety
The study was stopped early (reason given: Due to change in the national policy of medications). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Loven, M.D. study director
HaEmek Medical Center, Oncology Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cytophosphan, Celecoxib, Methotrexate in people with Ovarian Carcinoma, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to change in the national policy of medications). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Progression (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.