Metastatic Colorectal CancerPhase 2POLAFNCT02970916
Phase II Trial to Assess FOLFIRI+Aflibercept Efficacy in Patients With Oxaliplatin-pretreated Metastatic Colorectal Cancer With or Without ACE Polymorphisms
A Phase 2 study testing FOLFIRI+aflibercept in people with Metastatic Colorectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.
Trial summary
The purpose of this study is to assess FOLFIRI+aflibercept efficacy in patients with or without ACE polymorphisms in terms of Progression-free survival (PFS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- FOLFIRI+aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2016to Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent, and willing and able to comply with protocol requirements,
- Histologically proven adenocarcinoma of the colon and/or rectum,
- Metastatic disease confirmed.
- Existence of at least one measurable unidimensional lesion using CT or MRI based on the RECIST criteria, version 1.1
- Patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen.
- Age ≥18 years
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- World Health Organization (WHO) Performance status (PS) 0-2,
- Hematological status: neutrophils (ANC) ≥1.5x109 /L; platelets ≥100x109 /L; haemoglobin ≥9g/dL
- Adequate renal function: serum creatinine level < 1.5 x ULN
- Adequate liver function: serum bilirubin ≤1.5 x upper normal limit (ULN), alkaline phosphatase (ALP) <5xULN
- Proteinuria <2+ (dipstick urinalysis) or ≤1g/24hour.
- Regular follow-up feasible.
- For female patients of childbearing potential, negative serum pregnancy test
- Female patients must commit to using reliable and appropriate methods of contraception until at least three months after the end of study treatment (when applicable). Male patients with a partner of childbearing potential must agree to use contraception in addition to having their partner use another contraceptive method during the trial.
Who cannot join
- Uncontrolled hypercalcemia,
- Pre-existing permanent neuropathy (NCI grade >2)
- Uncontrolled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg), or history of hypertensive crisis, or hypertensive ncephalopathy,
- Concomitant protocol unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy),
- Treatment with any other investigational medicinal product within 28 days prior to study entry.
- Other serious and uncontrolled non-malignant disease,
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- History or evidence upon physical examination of CNS metastasis unless adequately treated (e.g. non irradiated CNS metastasis, seizure not controlled with standard medical therapy),
- Known Gilbert's syndrome
- Intolerance to atropine sulfate or loperamide
- Known dihydropyrimidine dehydrogenase deficiency
- Treatment with CYP3A4 inducers unless discontinued > 7 days prior to inclusion
- Any of the following in 3 months prior to inclusion: grade 3-4 gastrointestinal bleeding (unless due to resected tumor), treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, or diverticulitis.
- Other concomitant or previous malignancy, except: i/ adequately treated insitu carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for >5 years,
- Any other serious and uncontrolled non-malignant disease, major surgery or traumatic injury within the last 28 days
- Pregnant or breastfeeding women,
- Patients with known allergy to any excipient to study drugs,
- History of myocardial infarction and/or stroke within 6 months prior to inclusion, NYHA class III and IV congestive heart failure
- Bowel obstruction.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Spanish Cooperative Group for the Treatment of Digestive Tumors
Madrona, 28007
About this study
Official title: A Phase II Trial to Assess FOLFIRI+Aflibercept Efficacy in Patients With Oxaliplatin-pretreated Metastatic Colorectal Cancer With or Without ACE Polymorphisms
The purpose of this study is to assess FOLFIRI+aflibercept efficacy in patients with or without ACE polymorphisms in terms of Progression-free survival (PFS).
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- FOLFIRI+aflibercept
- Keywords
- metastatic colorectal cancer, FOLFIRI, aflibercept, oxaliplatin, ACE polymorphisms
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFIRI+afliberceptDrug
Aflibercept: 4 mg/kg administered intravenous infusion on day 1
FOLFIRI regimen immediately after aflibercept:
Irinotecan:180 mg/m2 intravenous infusion, folinic acid (dl racemic): 400 mg/m2 intravenous infusion, followed by 5-fluorouracil (5-FU): 400 mg/m2 intravenous bolus, followed by 5-FU: 2400 mg/m2 continuous intravenous infusion over 46 hours.
- folinic acid: 400 mg/m² (racémic) or 200 mg/m² (L-form)
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRI+aflibercept | Experimental | Not described Receives: Drug: FOLFIRI+aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
FOLFIRI+aflibercept efficacy in terms of Progression-free survival (PFS) with or without ACE polymorphisms.
Measured: 30 months
Secondary outcomes (7)
Progression free survival (PFS) with or without AGTR1 polymorphisms, according Serum-level sACE
Measured: 30 months
Objective Response Rate (ORR) with or without ACE polymorphisms, AGTR1 polymorphisms, according Serum-level sACE
Measured: 30 months
Disease Control Rate (DCR) with or without ACE polymorphisms, AGTR1 polymorphisms, according Serum-level sACE
Measured: 30 months
Time to progression (TP) with or without ACE polymorphisms, AGTR1 polymorphisms, according Serum-level sACE
Measured: 30 months
Time to treatment failure (TTF) with or without ACE polymorphisms, AGTR1 polymorphisms, according Serum-level sACE
Measured: 30 months
Overall survival (OS) with or without ACE polymorphisms, AGTR1 polymorphisms, according Serum-level sACE
Measured: 30 months
Number of participants with adverse events as assessed by CTCAE v4.0.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMay 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Enrique Aranda, MD-PhD, Study chair, Hospital General Universitario Reina Sofía de MurciaAuxiliadora Gómez, MD-PhD, Study chair, Hospital General Universitario Reina Sofía de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970916
- Sponsor's protocol ID
- TTD-16-02
- Acronym
- POLAF
- Status last verified
- Apr 2019
- First submitted
- 16 Nov 2016
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial to Assess FOLFIRI+Aflibercept Efficacy in Patients With Oxaliplatin-pretreated Metastatic Colorectal Cancer With or Without ACE Polymorphisms
- ClinicalTrials.gov ID
- NCT02970916
- Acronym / sponsor ID
- POLAF / TTD-16-02
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- metastatic colorectal cancer, FOLFIRI, aflibercept, oxaliplatin, ACE polymorphisms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)University, hospital or other
- Collaborators
- Sanofi
- Study start
- Nov 2016
- Primary completion
- May 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 22 Nov 2016 (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.
The purpose of this study is to assess FOLFIRI+aflibercept efficacy in patients with or without ACE polymorphisms in terms of Progression-free survival (PFS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFIRI+aflibercept | Experimental | Drug: FOLFIRI+aflibercept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed and dated informed consent, and willing and able to comply with protocol requirements,
- Histologically proven adenocarcinoma of the colon and/or rectum,
- Metastatic disease confirmed.
- Existence of at least one measurable unidimensional lesion using CT or MRI based on the RECIST criteria, version 1.1
- Patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen.
Key exclusion criteria (18 listed)
- Uncontrolled hypercalcemia,
- Pre-existing permanent neuropathy (NCI grade >2)
- Uncontrolled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg), or history of hypertensive crisis, or hypertensive ncephalopathy,
- Concomitant protocol unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy),
- Treatment with any other investigational medicinal product within 28 days prior to study entry.
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 |
|---|---|---|
| FOLFIRI+afliberceptAflibercept: 4 mg/kg administered intravenous infusion on day 1 FOLFIRI regimen immediately after aflibercept: Irinotecan:180 mg/m2 intravenous infusion, folinic acid (dl racemic): 400 mg/m2 intravenous infusion, followed by 5-fluorouracil (5-FU): 400 mg/m2 intravenous bolus, followed by 5-FU: 2400 mg/m2 continuous intravenous infusion over 46 hours. * folinic acid: 400 mg/m² (racémic) or 200 mg/m² (L-form) | Drug | FOLFIRI+aflibercept |
Primary outcome
FOLFIRI+aflibercept efficacy in terms of Progression-free survival (PFS) with or without ACE polymorphisms.
Time frame: 30 months
7 secondary outcomes
Progression free survival (PFS) with or without AGTR1 polymorphisms, according Serum-level sACE
Time frame: 30 months
Objective Response Rate (ORR) with or without ACE polymorphisms, AGTR1 polymorphisms, according Serum-level sACE
Time frame: 30 months
Disease Control Rate (DCR) with or without ACE polymorphisms, AGTR1 polymorphisms, according Serum-level sACE
Time frame: 30 months
Time to progression (TP) with or without ACE polymorphisms, AGTR1 polymorphisms, according Serum-level sACE
Time frame: 30 months
Time to treatment failure (TTF) with or without ACE polymorphisms, AGTR1 polymorphisms, according Serum-level sACE
Time frame: 30 months
Overall survival (OS) with or without ACE polymorphisms, AGTR1 polymorphisms, according Serum-level sACE
Time frame: 30 months
Number of participants with adverse events as assessed by CTCAE v4.0.
Time frame: 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
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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.
Enrique Aranda, MD-PhD study chair
Hospital General Universitario Reina Sofía de Murcia
Auxiliadora Gómez, MD-PhD study chair
Hospital General Universitario Reina Sofía de Murcia
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 FOLFIRI+aflibercept in people with Metastatic Colorectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.
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 14 inclusion and 18 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: finished, as of the sponsor's last update on 11 Apr 2019. 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 Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
FOLFIRI+aflibercept efficacy in terms of Progression-free survival (PFS) with or without ACE polymorphisms. (time frame: 30 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 11 Apr 2019.