Colorectal Cancer MetastaticPhase 2NCT01668680
Maintenance Metronomic Chemotherapy for Metastatic Colorectal Carcinoma
A Phase 2 study testing CAPECITABINE, CELECOXIB and METHOTREXATE in people with Colorectal Cancer Metastatic, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Colorectal cancer patients with metastases (mCRC) at response under expensive chemotherapy which may be toxic +/- exhausting are candidates for an effective and more convenient maintenance treatment. Objectives: 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- CAPECITABINE, CELECOXIB and METHOTREXATE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2012to Dec 2014
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic (or cytologic) proof of colorectal carcinoma (CRC).
- Age: between 18 and 80.
- Sex: both sexes.
- Previous treatment for metastatic disease is limited to FOLFIRI+ bevacizumab.
- Prior adjuvant chemotherapy, with a fluoropyrimidine and/or Oxaliplatin, is allowed.
- Prior radiotherapy, either as adjuvant treatment or palliation of metastatic sites is allowed, provided that there are other non-irradiated foci of disease for evaluation.
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- Persistent remission, either complete, partial or minimal response (CR, PR or MR) or stable disease (SD), one year+/-one month from initiation of first line treatment for mCRC.
- Asymptomatic patients at break from chemotherapy.
- Intact organ function, including complete blood counts (CBC) showing normal values or any toxicity limited to grade 1 and blood chemistry (SMA) showing liver and renal functions < 1.5 upper normal limit (UNL).
- Capability to understand and to sign the informed consent.
Who cannot join
- Concurrent any other cancer (except BCC or squamous cell carcinoma of skin).
- Inability to adhere to monthly visits to the oncology unit for evaluation.
- Presence of brain metastases.
- Any current or recent (within the last month) continuous treatment by steroids or by NSAIDs, or with therapeutic doses of anticoagulants for any reason.
- Previous radiotherapy to the only site of measurable disease.
- Evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac including arrhythmias, hepatic or renal disease), and/or existence of active peptic ulcer (clinically and/or by gastroscopy).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metronomic Chemotherapy With Anti-angiogenic Effect as Maintenance Treatment for Metastatic Colorectal Carcinoma Following Response to FOLFIRI+Bevacizumab: Clinical and Laboratory Studies
Colorectal cancer patients with metastases (mCRC) at response under expensive chemotherapy which may be toxic +/- exhausting are candidates for an effective and more convenient maintenance treatment.
Objectives:
Read more
- To define the efficacy of maintenance chemotherapy by a low-dose metronomic (LDM) regimen, in metastatic CRC patients responding under FOLFIRI + bevacizumab.
- To discover predictive factors for response to this LDM regimen.
Hypothesis:
- The re-growth of residual metastases can be slowed by the anti-angiogenic effects of LDM chemotherapy.
- Serial measurements of angiogenic/ inflammatory factors in the plasma and/or evaluation of certain enzymes in the tumor may discover predictive factors of response to LDM chemotherapy in metastatic CRC patients.
Read the detailed description
At entry to the research protocol the up-till then administered treatment with Intra Venous FOLFIRI+BEVACIZUMAB will be stopped.Instead, the research oral treatment will be initiated to be taken daily on an ambulatory basis and under once monthly re-evaluation. If and when disease progresses the original FOLFIRI+BEVACIZUMAB treatment will be considered for re-institution.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- CAPECITABINE, CELECOXIB and METHOTREXATE
- Keywords
- Metronomic Chemotherapy, Anti-Angiogenic, Maintenance Treatment, Colorectal Cancer Metastatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPECITABINE, CELECOXIB and METHOTREXATEDrug
Also called Metronomic Chemotherapy
daily oral treatment with CAPECITABINE, CELECOXIB and METHOTREXATE
| Study group | Role | What they receive |
|---|---|---|
| LDM anti-angiogenic chemotherapy | Experimental | LDM (Low Dose Metronomic) anti-angiogenic chemotherapy includes daily oral treatment with CAPECITABINE, CELECOXIB and METHOTREXATE. Receives: Drug: CAPECITABINE, CELECOXIB and METHOTREXATE |
| observation | No intervention | observation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of progression free survival (PFS), measured in months.
From start of the experimental treatment until the date of first documented progression or date of death of any cause,whichever came first, assessed up to 12 months.
Measured: Up to 12 months.
Secondary outcomes (3)
Toxicity profile of treatment, defined by CTCAE Version 4.0.
From start of the experimental treatment until the date of first documented progression or date of death of any cause,whichever came first, assessed up to 12 months.
Measured: up to12 months
Changes in levels of angiogenic factors while under treatment: VEGF, PDGF, TSP-1
Change from baseline in levels of angiogenic factors at 4 months of treatment.
Measured: Up to 4 months.
Quality of life, as expressed by FACT-C.
Change from baseline in parameters of Quality of life until the end of treatment, assessed up to 12 months.
Measured: Up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2013
- Study completionDec 2014
Why it stopped: No satisfactory acrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- Clalit Health Services
- Responsible party
- Sponsor
- Investigators
- David Loven, MD, Principal investigator, Ha'Emek MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668680
- Sponsor's protocol ID
- EMC-0047-11
- Status last verified
- Jul 2015
- First submitted
- 11 Mar 2012
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metronomic Chemotherapy With Anti-angiogenic Effect as Maintenance Treatment for Metastatic Colorectal Carcinoma Following Response to FOLFIRI+Bevacizumab: Clinical and Laboratory Studies
- ClinicalTrials.gov ID
- NCT01668680
- Acronym / sponsor ID
- EMC-0047-11
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- Metronomic Chemotherapy, Anti-Angiogenic, Maintenance Treatment, Colorectal Cancer Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No satisfactory acrual
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Collaborators
- Clalit Health Services
- Study start
- Sep 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Aug 2012 (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.
Colorectal cancer patients with metastases (mCRC) at response under expensive chemotherapy which may be toxic +/- exhausting are candidates for an effective and more convenient maintenance treatment.
Objectives:
- To define the efficacy of maintenance chemotherapy by a low-dose metronomic (LDM) regimen, in metastatic CRC patients responding under FOLFIRI + bevacizumab.
- To discover predictive factors for response to this LDM regimen.
Hypothesis:
- The re-growth of residual metastases can be slowed by the anti-angiogenic effects of LDM chemotherapy.
- Serial measurements of angiogenic/ inflammatory factors in the plasma and/or evaluation of certain enzymes in the tumor may discover predictive factors of response to LDM chemotherapy in metastatic CRC patients.
Detailed description
At entry to the research protocol the up-till then administered treatment with Intra Venous FOLFIRI+BEVACIZUMAB will be stopped.Instead, the research oral treatment will be initiated to be taken daily on an ambulatory basis and under once monthly re-evaluation. If and when disease progresses the original FOLFIRI+BEVACIZUMAB treatment will be considered for re-institution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LDM anti-angiogenic chemotherapy | Experimental | Drug: CAPECITABINE, CELECOXIB and METHOTREXATELDM (Low Dose Metronomic) anti-angiogenic chemotherapy includes daily oral treatment with CAPECITABINE, CELECOXIB and METHOTREXATE. |
| observation | No intervention | –observation only |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologic (or cytologic) proof of colorectal carcinoma (CRC).
- Age: between 18 and 80.
- Sex: both sexes.
- Previous treatment for metastatic disease is limited to FOLFIRI+ bevacizumab.
- Prior adjuvant chemotherapy, with a fluoropyrimidine and/or Oxaliplatin, is allowed.
Key exclusion criteria (6 listed)
- Concurrent any other cancer (except BCC or squamous cell carcinoma of skin).
- Inability to adhere to monthly visits to the oncology unit for evaluation.
- Presence of brain metastases.
- Any current or recent (within the last month) continuous treatment by steroids or by NSAIDs, or with therapeutic doses of anticoagulants for any reason.
- Previous radiotherapy to the only site of measurable disease.
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 |
|---|---|---|
| CAPECITABINE, CELECOXIB and METHOTREXATEAlso: Metronomic Chemotherapydaily oral treatment with CAPECITABINE, CELECOXIB and METHOTREXATE | Drug | LDM anti-angiogenic chemotherapy |
Primary outcome
Length of progression free survival (PFS), measured in months.
Time frame: Up to 12 months.
From start of the experimental treatment until the date of first documented progression or date of death of any cause,whichever came first, assessed up to 12 months.
3 secondary outcomes
Toxicity profile of treatment, defined by CTCAE Version 4.0.
Time frame: up to12 months
Changes in levels of angiogenic factors while under treatment: VEGF, PDGF, TSP-1
Time frame: Up to 4 months.
Quality of life, as expressed by FACT-C.
Time frame: Up to 12 months.
Results and safety
The study was stopped early (reason given: No satisfactory acrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
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CRC
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, MD principal investigator
Ha'Emek MC
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 CAPECITABINE, CELECOXIB and METHOTREXATE in people with Colorectal Cancer Metastatic, 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 10 inclusion and 6 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 8 Jul 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: No satisfactory acrual). 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?
Length of progression free survival (PFS), measured in months. (time frame: Up to 12 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 8 Jul 2015.