Colorectal Cancer Stage IVPhase 2IMPROVENCT04425239
Intermittent or Continuous Panitumumab Plus FOLFIRI for RAS/B-RAF Wild-type Metastatic Colorectal Cancer
A Phase 2 study testing Panitumumab in people with Colorectal Cancer Stage IV, run by National Cancer Institute, Naples at 1 site in Italy.
Trial summary
The investigators hypothesize that intermittent first-line Panitumumab plus FOLFIRI is effective as the same regimen given continuously, in unresectable metastatic RAS and BRAF wild type colorectal cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Stage IV
- What is being tested?
- Panitumumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteItaly
- Study dates
- 21 May 2018to 3 Apr 2022
- 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
- Written informed consent to study procedures and to molecular analyses;
- Histologically proven diagnosis of colorectal cancer with wildtype RAS and BRAF status in certified laboratories;
- Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease;
- At least one measurable lesion according to RECIST1.1 criteria;
- Availability of a tumor sample (primary and/or metastatic sites) for exploratory research;
- Age ≥ 18 years;
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- ECOG PS ≤ 2;
- Life expectancy of at least 12 weeks;
- Previous adjuvant chemotherapy allowed only if more than 6 months elapsed between the end of adjuvant and first relapse;
- Neutrophils ≥ 1.5 x 109/L, Platelets ≥100 x 109/L, Hgb ≥ 9 g/dl;
- Total bilirubin ≤1.5 time the upper-normal limits (UNL) of the normal values and ASAT (SGOT) and/or ALAT (SGPT) ≤ 2.5 x UNL (or < 5 x UNL in case of liver metastases) alkaline phosphatase ≤ 2.5 x UNL (or < 5 x UNL in case of liver metastases);
- Creatinine clearance ≥50 mL/min or serum creatinine ≤ 1.5 x UNL;
- Female with a childbearing potential and male subjects must be willing to use adequate contraception (barrier contraceptive measure, oral contraception, intrauterine device);
- Will and ability to comply with the protocol.
Who cannot join
- Previous treatment for metastatic disease;
- Radiotherapy to any site within 4 weeks before the study;
- Any contraindication to use Panitumumab, Irinotecan, 5-FU or folinic acid
- Known or clinically suspected brain metastases.
- History or evidence upon physical examination of CNS disease unless adequately treated.
- Ascites, pleural effusion or pericardial fluid requiring drainage in last 4 weeks.
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- Diagnosis of interstitial pneumonitis or pulmonary fibrosis;
- Active uncontrolled infections or other clinically relevant concomitant illness contraindicating chemotherapy administration or which, in the investigating physician's opinion, rules out the patient's participation in the study;
- Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤6 months), myocardial infarction (≤6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), serious cardiac arrhythmia requiring medication;
- Treatment with any investigational drug within 30 days prior to enrolment;
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of localized basal and squamous cell carcinoma or cervical cancer in situ;
- Lack of physical integrity of the gastrointestinal tract or history of acute or sub-acute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhea.
- Disease that is deemed potentially resectable.
- Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs.
- Any concomitant drugs contraindicated for use with the trial drugs according to the product information of the pharmaceutical companies.
- Breastfeeding
- Sexually active males and females (of childbearing potential) unwilling to practice contraception (barrier contraceptive measure or oral contraception) during the study and until 6 months after the last trial treatment.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale
Naples, 80131
About this study
Official title: Intermittent or Continuous Panitumumab Plus FOLFIRI for First-line Treatment of Patients With RAS/B-RAF Wild-type Metastatic Colorectal Cancer: a Randomized Phase 2 Trial
The investigators hypothesize that intermittent first-line Panitumumab plus FOLFIRI is effective as the same regimen given continuously, in unresectable metastatic RAS and BRAF wild type colorectal cancer patients. Correlative studies on tumor and blood samples could identify potential biomarkers of efficacy and help defining personalized treatment strategy.
Read the detailed description
This will be a multicenter open label randomized phase II study. The study population will include untreated RAS wild-type metastatic colorectal (mCRC) patients with unresectable disease. A total of 136 patients will be enrolled.
All Patients will receive an induction treatment with panitumumab as 1 hour intravenous infusion at the dosage of 6 mg/kg, given every two weeks, plus FOLFIRI chemotherapy as standard guidelines.
Before start of FOLFIRI plus panitumumab, at the time of enrollment, patients will be immediately randomized electronically 1:1 to one of the two arms. Induction treatment with FOLFIRI plus panitumumab will continue until progressive disease, unacceptable toxicity or informed consent withdrawal, or for up to 8 cycles. At the end of induction treatment, in presence of complete or partial response, or stable disease, non-progressing patients will be allocated to one of the two pre-assigned arms:
- CONTINOUS: FOLFIRI plus panitumumab until progressive disease, unacceptable toxicity or informed consent withdrawal. Panitumumab will be administered as a 6 mg/kg intravenous infusion over 60 minutes (day 1) every 2 weeks. The dose of Panitumumab should be administered prior to chemotherapy. Irinotecan will be administered as a 180 mg/m2 intravenous infusion over 60 minutes (day 1) every 2 weeks. Folinic acid will be administered as a 200 mg/m2 intravenous infusion over 120 minutes before 5- fluorouracil infusion (day 1) every 2 weeks. 5-fluorouracil will be administered as a 400 mg/m2 intravenous bolus injection (day 1) followed by 2400 mg/m246-hours continuous infusion (day 1), every 2 weeks. Cycle length will be 2 weeks +/- 3 days.
- INTERMITTENT: treatment free interval until progressive disease; followed by up to 8 cycles of FOLFIRI plus panitumumab; in presence of complete or partial response, or stable disease, non-progressing patients will undergo again to treatment free interval until PD, when they will restart treatment. Treatment cycling will continue till any progressive disease on treatment. Panitumumab will be administered at same dose and infusion with FOLFIRI.
All measurable and non-measurable lesions must be documented at screening (within 21 days prior to randomization) and re-assessed at each subsequent tumor evaluation (every 8 weeks while the patient is on study). Tumor assessment by CT scan of chest, abdomen and pelvis; CEA, CA 19.9; and any other tests having resulted positive during baseline staging, will be performed at week 8 and every 8 weeks thereafter, until disease progression, accordingly with RECIST V 1.1 criteria.
Toxicities will be evaluated throughout the study treatment and graded according to the NCI Common Toxicity Criteria.
The National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTC-AE) Version 4.03 will be used to evaluate the clinical safety of the treatment in this study. Patients will be assessed for AEs at each clinical visit and as necessary throughout the study.
Quality of Life is assessed by the EORTC QLQ-C30, v. 3.0 questionnaire that are completed by patients at baseline, at week 16 and every 8 weeks thereafter.
Biomarkers ancillary study Correlative biological studies will be performed for the evaluation of the biomarkers indicated above on the biological samples available (paraffin-embedded tissue, frozen tissue, blood, serum, etc.). Biomarkers will be evaluated on archival tumor tissues or on newly obtained biopsies at baseline, and during treatment when available. Blood Samples will be collected at baseline, at week 8, 16 and thereafter every 8 weeks concomitantly with tumor assessment.
The sample size is calculated on the basis of median progression-free survival on treatment with intermittent vs continuous Panitumumab plus FOLFIRI, taking into account a median PFS of 11 months observed in the CRYSTAL trial.
The study is designed as a phase II trial with a random assignment to a calibration arm (continous) and to the experimental arm (intermittent). The sample size for intermittent arm is calculated according to the binomial test. The calibration arm has the same sample size, its role is to give a parallel estimation of median PFS to ensure that sample is representative and results are consistent However considering a 5% of drop-outs mainly due to losses to follow-up, the sample size is increased from 130 to 136 patients.
Randomization will be performed with a minimization procedure that will account for center; ECOG (PS 0-1 vs 2); primary site of tumor (Right versus Left); adjuvant treatment (yes vs no); metastatic sites (1 vs>1).
- Conditions
- Colorectal Cancer Stage IV
- Being tested
- Panitumumab
- Keywords
- metastatic colorectal cancer, RAS and BRAF wild type, intermittent therapy, liquid biopsy, panitumumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanitumumabDrug
Also called Irinotecan, Fluorouracil plus folinic acid
Continuous administation
PanitumumabDrug
Also called Irinotecan, Fluorouracil plus folinic acid
Intermittent administation
| Study group | Role | What they receive |
|---|---|---|
| CONTINUOUS ARM: | Active comparator | Patients will receive Panitumumab plus FOLFIRI until progressive disease, unacceptable toxicity or informed consent withdrawal. Receives: Drug: Panitumumab |
| INTERMITTENT ARM: | Experimental | Patients will have a treatment free interval until progressive disease (PD), when they will receive up to 8 cycles of Panitumumab plus FOLFIRI. In the presence of complete or partial response, or stable disease, non-progressing patients will undergo again to treatment free interval until PD, when they will restart treatment. Treatment cycling will continue till any PD on treatment. Receives: Drug: Panitumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Progression Free Survival on treatment (PFSOT) is defined as the time from randomization to the first objective disease progression documented in patients undergoing treatment cycle (objective disease progression during treatment free intervals are excluded) or death due to any cause, whichever occurs first.
Measured: up to 1 year last patients randomized
Secondary outcomes (1)
Overall Survival (OS)
Overall Survival is defined as the time from randomization to the date of death
Measured: up to 1 year last patients randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start21 May 2018
- Primary completion2 Jul 2021
- Study completion3 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer Stage IVStudies 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
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Avallone, MD, Principal investigator, Istituto Nazionale dei Tumori di Napoli - IRCCS - Fondazione G. Pascale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425239
- Sponsor's protocol ID
- IMPROVE
- Acronym
- IMPROVE
- Status last verified
- Sep 2021
- First submitted
- 3 May 2020
- Last updated
- 7 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Avallone A, Giuliani F, De Stefano A, Santabarbara G, Nasti G, Montesarchio V, Rosati G, Cassata A, Leo S, Romano C, Tamburini E, Silvestro L, Lotesoriere C, Nappi A, Santini D, Petrillo A, Colombo A, Febbraro A, Leone A, Mannavola F, Laterza MM, Izzo F, Sobrero A, Delrio P, Giannarelli D, Budillon A. Intermittent or Continuous Panitumumab Plus Fluorouracil, Leucovorin, and Irinotecan for First-Line Treatment of RAS and BRAF Wild-Type Metastatic Colorectal Cancer: The IMPROVE Trial. J Clin Oncol. 2025 Mar;43(7):829-839. doi: 10.1200/JCO.24.00979. Epub 2024 Nov 22.
PubMed 39576946
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent or Continuous Panitumumab Plus FOLFIRI for First-line Treatment of Patients With RAS/B-RAF Wild-type Metastatic Colorectal Cancer: a Randomized Phase 2 Trial
- ClinicalTrials.gov ID
- NCT04425239
- Acronym / sponsor ID
- IMPROVE / IMPROVE
- Conditions
- Colorectal Cancer Stage IV
- Keywords
- metastatic colorectal cancer, RAS and BRAF wild type, intermittent therapy, liquid biopsy, panitumumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- 21 May 2018 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 3 Apr 2022 (actual)
- First posted
- 11 Jun 2020 (actual)
- 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 investigators hypothesize that intermittent first-line Panitumumab plus FOLFIRI is effective as the same regimen given continuously, in unresectable metastatic RAS and BRAF wild type colorectal cancer patients. Correlative studies on tumor and blood samples could identify potential biomarkers of efficacy and help defining personalized treatment strategy.
Detailed description
This will be a multicenter open label randomized phase II study. The study population will include untreated RAS wild-type metastatic colorectal (mCRC) patients with unresectable disease. A total of 136 patients will be enrolled.
All Patients will receive an induction treatment with panitumumab as 1 hour intravenous infusion at the dosage of 6 mg/kg, given every two weeks, plus FOLFIRI chemotherapy as standard guidelines.
Before start of FOLFIRI plus panitumumab, at the time of enrollment, patients will be immediately randomized electronically 1:1 to one of the two arms. Induction treatment with FOLFIRI plus panitumumab will continue until progressive disease, unacceptable toxicity or informed consent withdrawal, or for up to 8 cycles. At the end of induction treatment, in presence of complete or partial response, or stable disease, non-progressing patients will be allocated to one of the two pre-assigned arms:
- CONTINOUS: FOLFIRI plus panitumumab until progressive disease, unacceptable toxicity or informed consent withdrawal. Panitumumab will be administered as a 6 mg/kg intravenous infusion over 60 minutes (day 1) every 2 weeks. The dose of Panitumumab should be administered prior to chemotherapy. Irinotecan will be administered as a 180 mg/m2 intravenous infusion over 60 minutes (day 1) every 2 weeks. Folinic acid will be administered as a 200 mg/m2 intravenous infusion over 120 minutes before 5- fluorouracil infusion (day 1) every 2 weeks. 5-fluorouracil will be administered as a 400 mg/m2 intravenous bolus injection (day 1) followed by 2400 mg/m246-hours continuous infusion (day 1), every 2 weeks. Cycle length will be 2 weeks +/- 3 days.
- INTERMITTENT: treatment free interval until progressive disease; followed by up to 8 cycles of FOLFIRI plus panitumumab; in presence of complete or partial response, or stable disease, non-progressing patients will undergo again to treatment free interval until PD, when they will restart treatment. Treatment cycling will continue till any progressive disease on treatment. Panitumumab will be administered at same dose and infusion with FOLFIRI.
All measurable and non-measurable lesions must be documented at screening (within 21 days prior to randomization) and re-assessed at each subsequent tumor evaluation (every 8 weeks while the patient is on study). Tumor assessment by CT scan of chest, abdomen and pelvis; CEA, CA 19.9; and any other tests having resulted positive during baseline staging, will be performed at week 8 and every 8 weeks thereafter, until disease progression, accordingly with RECIST V 1.1 criteria.
Toxicities will be evaluated throughout the study treatment and graded according to the NCI Common Toxicity Criteria.
The National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTC-AE) Version 4.03 will be used to evaluate the clinical safety of the treatment in this study. Patients will be assessed for AEs at each clinical visit and as necessary throughout the study.
Quality of Life is assessed by the EORTC QLQ-C30, v. 3.0 questionnaire that are completed by patients at baseline, at week 16 and every 8 weeks thereafter.
Biomarkers ancillary study Correlative biological studies will be performed for the evaluation of the biomarkers indicated above on the biological samples available (paraffin-embedded tissue, frozen tissue, blood, serum, etc.). Biomarkers will be evaluated on archival tumor tissues or on newly obtained biopsies at baseline, and during treatment when available. Blood Samples will be collected at baseline, at week 8, 16 and thereafter every 8 weeks concomitantly with tumor assessment.
The sample size is calculated on the basis of median progression-free survival on treatment with intermittent vs continuous Panitumumab plus FOLFIRI, taking into account a median PFS of 11 months observed in the CRYSTAL trial.
The study is designed as a phase II trial with a random assignment to a calibration arm (continous) and to the experimental arm (intermittent). The sample size for intermittent arm is calculated according to the binomial test. The calibration arm has the same sample size, its role is to give a parallel estimation of median PFS to ensure that sample is representative and results are consistent However considering a 5% of drop-outs mainly due to losses to follow-up, the sample size is increased from 130 to 136 patients.
Randomization will be performed with a minimization procedure that will account for center; ECOG (PS 0-1 vs 2); primary site of tumor (Right versus Left); adjuvant treatment (yes vs no); metastatic sites (1 vs>1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTINUOUS ARM: | Active comparator | Drug: PanitumumabPatients will receive Panitumumab plus FOLFIRI until progressive disease, unacceptable toxicity or informed consent withdrawal. |
| INTERMITTENT ARM: | Experimental | Drug: PanitumumabPatients will have a treatment free interval until progressive disease (PD), when they will receive up to 8 cycles of Panitumumab plus FOLFIRI. In the presence of complete or partial response, or stable disease, non-progressing patients will undergo again to treatment free interval until PD, when they will restart treatment. Treatment cycling will continue till any PD on treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Written informed consent to study procedures and to molecular analyses;
- Histologically proven diagnosis of colorectal cancer with wildtype RAS and BRAF status in certified laboratories;
- Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease;
- At least one measurable lesion according to RECIST1.1 criteria;
- Availability of a tumor sample (primary and/or metastatic sites) for exploratory research;
Key exclusion criteria (17 listed)
- Previous treatment for metastatic disease;
- Radiotherapy to any site within 4 weeks before the study;
- Any contraindication to use Panitumumab, Irinotecan, 5-FU or folinic acid
- Known or clinically suspected brain metastases.
- History or evidence upon physical examination of CNS disease unless adequately treated.
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 |
|---|---|---|
| PanitumumabAlso: Irinotecan, Fluorouracil plus folinic acidContinuous administation | Drug | INTERMITTENT ARM: |
| PanitumumabAlso: Irinotecan, Fluorouracil plus folinic acidIntermittent administation | Drug | CONTINUOUS ARM: |
Primary outcome
Progression-free Survival
Time frame: up to 1 year last patients randomized
Progression Free Survival on treatment (PFSOT) is defined as the time from randomization to the first objective disease progression documented in patients undergoing treatment cycle (objective disease progression during treatment free intervals are excluded) or death due to any cause, whichever occurs first.
1 secondary outcome
Overall Survival (OS)
Time frame: up to 1 year last patients randomized
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 7 Apr 2022.
- Derived from this study: PubMed 39576946Avallone A, Giuliani F, De Stefano A, Santabarbara G, Nasti G, Montesarchio V, Rosati G, Cassata A, Leo S, Romano C, Tamburini E, Silvestro L, Lotesoriere C, Nappi A, Santini D, Petrillo A, Colombo A, Febbraro A, Leone A, Mannavola F, Laterza MM, Izzo F, Sobrero A, Delrio P, Giannarelli D, Budillon A. Intermittent or Continuous Panitumumab Plus Fluorouracil, Leucovorin, and Irinotecan for First-Line Treatment of RAS and BRAF Wild-Type Metastatic Colorectal Cancer: The IMPROVE Trial. J Clin Oncol. 2025 Mar;43(7):829-839. doi: 10.1200/JCO.24.00979. Epub 2024 Nov 22.
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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.
Antonio Avallone, MD principal investigator
Istituto Nazionale dei Tumori di Napoli - IRCCS - Fondazione G. Pascale
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 Panitumumab in people with Colorectal Cancer Stage IV, run by National Cancer Institute, Naples at 1 site in Italy.
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 17 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 7 Apr 2022. 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 Italy. 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: up to 1 year last patients randomized). 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 NCT04425239, which also lists 1 linked publication.
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 7 Apr 2022; AzTrials last refreshed its copy on 31 Oct 2026.