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Unresectable Metastatic Colorectal CancerPhase 2VELVETNCT01802684

OPTIMOX-aflibercept as First-line Therapy in Patients With Unresectable Metastatic Colorectal Cancer

A Phase 2 study testing aflibercept in people with Unresectable Metastatic Colorectal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 8 sites in France.

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

Evaluation of feasibility of adding aflibercept to an oxaliplatin-based regimen rather than a continuous administration of chemotherapy until progression, in order to decrease the risk of severe toxicities. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
aflibercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
8 sitesFrance
Study dates
May 2013to Jun 2016
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,
  • No prior therapy for metastatic disease (in case of previous adjuvant therapy, interval from end of chemotherapy to relapse must be >6 months for fluoropyrimidine alone or >12 months for oxaliplatin-based, bevacizumab-based, cetuximab-based therapy,
  • Duly documented inoperable metastatic disease, ie not suitable for complete carcinological surgical resection,
  • At least one measurable or evaluable lesion as assessed by CT-scan or MRI (Magnetic Resonance Imaging) according to RECIST v1.1,
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  • Age ≥18 years,
  • ECOG Performance status (PS) 0-2,
  • Hematological status: neutrophils (ANC) ≥1.5x109/L; platelets ≥100x109/L; haemoglobin ≥9g/dL,
  • Adequate renal function: serum creatinine level <150µM,
  • Adequate liver function: serum bilirubin ≤3 x upper normal limit (ULN), alkaline phosphatase <5xULN,
  • Proteinuria <2+ (dipstick urinalysis) or ≤1g/24hour,
  • Baseline evaluations: clinical and blood evaluations performed no more than 2 weeks (14 days) prior to confirmation of eligibility, tumor assessment (chest X ray, CT-scan or MRI, evaluation of non-measurable lesions) no more than 3 weeks (21 days) prior to confirmation of eligibility,
  • For female patients of childbearing potential, negative serum or urine pregnancy test within 1 week (7 days) prior of starting study treatment,
  • Female patients of childbearing potential must commit to using reliable and effective methods of contraception during the trial and until at least six months after the end of study treatment. Females are neither pregnant nor in breastfeeding. Male patients with a partner of childbearing potential must agree to use effective contraception in addition to the contraceptive method used by their partner during the trial and until at least six months after the end of study treatment.
  • Registration in a national health care system (CMU included for France).

Who cannot join

  • 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),
  • Exclusive bone metastasis,
  • 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 despite optimal medical therapy), or history of hypertensive crisis, or hypertensive encephalopathy,
  • Concomitant unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy/ radio-immunotherapy),
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  • Treatment with any other investigational medicinal product within 28 days prior to study entry,
  • Other serious and uncontrolled non-malignant disease,
  • Other concomitant or previous malignancy, except: i/ adequately treated in-situ 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 study entry,
  • Bowel obstruction.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

France8 sites

  • Polyclinique de Bordeaux Nord

    Bordeaux, 33300

  • Hôpital Henri Mondor

    Créteil, 94010

  • CHU Dupuytren

    Limoges, 87042

  • Hôpital Privé Jean Mermoz

    Lyon, 69008

  • CH Mont de Marsan

    Paris, 40000

  • Hôpital Saint-Antoine

    Paris, 75012

  • Hôpital Pitié Salpêtrière

    Paris, 75013

  • Institut Mutualiste Montsouris

    Paris, 75014

Other trials in France

About this study

Official title: OPTIMOX-aflibercept as First-line Therapy in 49 Patients With Unresectable Metastatic Colorectal Cancer. A GERCOR Feasibility Single-arm Phase II Study.

Evaluation of feasibility of adding aflibercept to an oxaliplatin-based regimen rather than a continuous administration of chemotherapy until progression, in order to decrease the risk of severe toxicities.

Read the detailed description

The addition of aflibercept to the standard FOLFIRI regimen as second-line therapy was evaluated in a large phase III study (EFC10262-VELOUR). This new combination significantly improved both PFS (4.7 to 6.9 months, HR=0.76; P=.00007) and OS (12.1 to 13.5 months, HR=0.82; P=.0032). In the evaluable population (86.5%), the tumor response rate was also improved when adding aflibercept (ORR=19.8% [16.4-23.2]) to the FOLFIRI regimen (ORR=11.1% [8.5-13.8]).

This trial will evaluate the feasibility of adding aflibercept to an oxaliplatin-based regimen as a first-line therapy , using the OPTIMOX strategy rather than a continuous administration of chemotherapy until progression, in order to decrease the risk of severe toxicities.

Being tested
aflibercept
Keywords
unresectable, metastatic, colorectal, cancer, OPTIMOX, aflibercept
Medical subject headings
Neoplasm Metastasis, Neoplasms

What participants receive

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

  • afliberceptBiological

    Aflibercept (VEGF Trap) Recombinant human protein, at 25 mg/ml Dose : 4 mg/Kg -Day 1, q2w Route of administration: Intravenous (60 min infusion)

Study groups in NCT01802684
Study groupRoleWhat they receive
OPTIMOX-afliberceptExperimentalInduction therapy (sequence #1) * Regimen : aflibercept + modified FOLFOX7 * Duration : 6 cycles (3 months) Maintenance after induction (sequence #2) First phase (sequence #2A) * Regimen : aflibercept + fluoropyrimidine (simplifed LV5FU2 or capecitabine) * Duration : 6 cycles (3 months) Second phase (sequence #2B) * Regimen : aflibercept +/- fluoropyrimidine (simplifed LV5FU2 or capecitabine) according to eligibility criteria for chemotherapy-free interval) * Duration : until PD or limiting toxicity Reintroduction (sequence #3) * Regimen : aflibercept + modified FOLFOX7 * Duration : 6 cycles (3 months) Maintenance after reintroduction (sequence #4) * Regimen : aflibercept + fluoropyrimidine * Duration : until PD or limiting toxicity
Receives: Biological: aflibercept

What is being measured

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

  1. Progression free survival at 6 months

    Measured: time interval from inclusion to the date of first documented disease progression or death from any cause, whichever occurs first. Assessed at 6 months.

Secondary outcomes (7)

  1. Median Progression Free Survival

    Measured: time interval from inclusion to the date of first documented disease progression or death from any cause, whichever occurs first. Assessed up to 3 years after the beginning of the study

  2. duration of disease control (DDC)

    DDC excludes:

    • Intervals between disease progression and re-initiation of treatment,
    • PFS of inactive treatment if PD occurs at first evaluation after treatment re-initiation

    Measured: sum of PFS of each active treatment course. Assessed up to 3 years after the beginning of the study

  3. Overall Survival

    Measured: time interval from inclusion to the date of death from any cause. Assessed up to 3 years after the beginning of the study.

  4. tumor Response Rate (RR)

    assessed using RECIST version 1.1 per sequence of therapy.

    Measured: Assessed every 2 months during treatment period (- Estimated treatment duration per patient : 16 months).

  5. Health related Quality of life

    EORTC QLQ C-30

    Measured: Assessed from study entry to 1 month after last study drug administration and up to 3 years after the beginning of the study.

  6. Safety

    The study will take into account all adverse events observed during and after drug administration, with a particular interest for:

    • Any AE
    • Any AE related to study treatment
    • Any serious AE
    • Any serious AE related to study treatment
    • Any NCI-CTC grade 3 or 4 AE
    • Any NCI-CTC grade 3 or 4 AE related to study treatment
    • Any AE causing discontinuation of study treatment
    • Any AE causing discontinuation of selected treatment only
    • Any AE related to study treatment causing discontinuation
    • Any AE causing a dose reduction of study medication
    • Any AE leading to death
    • Any AE related to study treatment leading to death.

    Measured: Assessed from study entry to 1 month after last study drug administration, assessed up to 3 years after the beginning of the study

  7. Curative salvage surgery

    The number of patient with R0 and R1 curative salvage surgery will be assessed globally and per sequence of therapy.

    Measured: assessed up to 3 years after the beginning of the study

Timeline

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

  1. First posted1 Mar 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionNov 2014
  4. Study completionJun 2016

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01802684
Sponsor's protocol ID
VELVET C12-1
Other IDs
2012-003521-25
Acronym
VELVET
Status last verified
Feb 2017
First submitted
26 Feb 2013
Last updated
1 Mar 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing aflibercept in people with Unresectable Metastatic Colorectal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 8 sites in France.

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 16 inclusion and 13 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 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France. 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 at 6 months (time frame: time interval from inclusion to the date of first documented disease progression or death from any cause, whichever occurs first. Assessed at 6 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 NCT01802684.

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 1 Mar 2017.

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