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Metastatic Colorectal CancerPhase 2AFEMANCT03279289

Study to Assess the Efficacy and Safety of Treatment With FOLFIRI-aflibercept Compared to Initial Treatment With FOLFIRI-aflibercept (for 6 Cycles) Followed by Maintenance With 5FU-aflibercept, in an Elderly Population With mCRC After Failure of an Oxaliplatin-based Regimen

A Phase 2 study testing Aflibercept, Irinotecan and folinic acid (dl racemic) in people with Metastatic Colorectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the efficacy and safety of treatment with FOLFIRI-aflibercept compared to initial treatment with FOLFIRI-aflibercept (for 6 cycles) followed by maintenance with 5FU-aflibercept, in an elderly population with metastatic colorectal cancer (mCRC) after failure of an… Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Aflibercept, Irinotecan and folinic acid (dl racemic)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
1 siteSpain
Study dates
25 Oct 2017to 9 Feb 2023
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 70 years and older
  • All sexes
  • No healthy volunteers
  • 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,
  • 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 a first line oxaliplatin-containing regimen for metastatic disease.
  • Age ≥70 years
  • World Health Organization (WHO) Performance status (PS) 0-2,
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  • Hematological status: neutrophils (ANC) ≥1.5x109 /L; platelets ≥100x109 /L; haemoglobin ≥9 g/dL
  • Adequate renal function: Creatinine clearance ≥50 mL/min as calculated using the Cockcroft-Gault equation.
  • 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.
  • 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 encephalopathy,
  • 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),
  • Patients classified as fragile or delicate according to the following criteria:
  • Dependence in one or more activities of daily living according to the Katz Index of Independence in Activities of Daily Living (ADL) scale
  • Three or more comorbidities when assessing the presence of the following processes: congestive heart failure; heart valve disease; coronary artery disease; chronic (obstructive or restrictive) pulmonary disease; cerebrovascular disease; peripheral neuropathy, chronic kidney failure; hypertension; diabetes; concomitant cancers; collagen vascular disease; chronic liver disease; and disabling arthritis
  • Presence of geriatric syndromes: moderate-severe dementia; delirium in stressful situations (urinary or respiratory tract infection, angina or drugs); moderate-severe depression that interferes with the patient's usual activity; frequent falls (three or more per month); inattentiveness (who could help you in the event of an emergency?); urinary incontinence in the absence of stress, infection, diuretics or prostatic hyperplasia; faecal incontinence in the absence of diarrhoea or laxatives; osteoporotic fractures of large bones or vertebral compression fractures
  • 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
  • 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.
  • Less than 28 days elapsed from prior radiotherapy
  • Patients with pernicious anemia or other megaloblastic anemias due to vitamin B12 deficiency
  • Patients with severe infections

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Spanish Cooperative Group for Digestive Tumour Therapy (TTD)

    Madrid, 28046

Other trials in Spain

About this study

Official title: Randomised, Multicentre, Phase II Pilot Study to Assess the Efficacy and Safety of Treatment With FOLFIRI-aflibercept Compared to Initial Treatment With FOLFIRI-aflibercept (for 6 Cycles) Followed by Maintenance With 5FU-aflibercept, in an Elderly Population With Metastatic Colorectal Cancer (mCRC) After Failure of an Oxaliplatin-based Regimen

The purpose of this study is to assess the efficacy and safety of treatment with FOLFIRI-aflibercept compared to initial treatment with FOLFIRI-aflibercept (for 6 cycles) followed by maintenance with 5FU-aflibercept, in an elderly population with metastatic colorectal cancer (mCRC) after failure of an oxaliplatin-based regimen

Being tested
Aflibercept, Irinotecan, folinic acid (dl racemic), 5Fluorouracil, 5-FU
Keywords
FOLFIRI, aflibercept, 5-FU, oxaliplatin, elderly, metastatic colorectal cancer
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AfliberceptDrug

    4 mg/kg administered intravenous infusion on day 1

  • IrinotecanDrug

    180 mg/m2 intravenous infusion

  • folinic acid (dl racemic)Drug

    400 mg/m2 intravenous infusion

  • 5FluorouracilDrug

    400 mg/m2 intravenous bolus

  • 5-FUDrug

    2400 mg/m2 continuous intravenous infusion over 46 hours

Study groups in NCT03279289
Study groupRoleWhat they receive
Group AExperimentalINDUCTION PHASE: 6 cycles of FOLFIRI + aflibercept MAINTENANCE PHASE: 5FU/LV + aflibercept
Receives: Drug: Aflibercept; Drug: Irinotecan; Drug: folinic acid (dl racemic); Drug: 5Fluorouracil; Drug: 5-FU
Group BActive comparatorFOLFIRI + aflibercept
Receives: Drug: Aflibercept; Drug: Irinotecan; Drug: folinic acid (dl racemic); Drug: 5Fluorouracil; Drug: 5-FU

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    Measured: 48 months

Secondary outcomes (9)

  1. Objective response rate based on the RECIST criteria

    Measured: 48 months

  2. Disease control rate

    Measured: 48 months

  3. Depth of response

    Measured: 48 months

  4. Time to progression

    Measured: 48 months

  5. Time to treatment failure

    Measured: 48 months

  6. Overall survival

    Measured: 48 months

  7. Incidence and severity of AEs CTCAE v4.03 criteria

    Measured: 48 months

  8. Incidence of dose adjustments and compliance

    Measured: 48 months

  9. VES-13 score (Vulnerable Elders Survey) as the utility measure for health deterioration

    Measured: 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2017
  2. Study start25 Oct 2017
  3. Primary completion9 Feb 2023
  4. Study completion9 Feb 2023

Resources

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
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03279289
Sponsor's protocol ID
TTD-16-03
Acronym
AFEMA
Status last verified
Apr 2023
First submitted
3 Aug 2017
Last updated
13 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aflibercept, Irinotecan and folinic acid (dl racemic) 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 12 inclusion and 24 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 13 Apr 2023. 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?

Progression-free survival (time frame: 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03279289.

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 13 Apr 2023.

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