EUCTR2017-003628-65-ITActive, not recruitingPhase 1
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 - IMPROVE InterMittent Panitumumab plus folfiRi in metastatic cOlorectal cancer VErsus continuous trea
ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE0 sites136 target enrollmentStarted: October 6, 2020Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 136
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1)Written informed consent to study procedures and to molecular
- •2) Histologically proven diagnosis of colorectal cancer with wildtype
- •RAS and BRAF status in certified laboratories;
- •3) Initially unresectable metastatic colorectal cancer not previously
- •treated with chemotherapy for metastatic disease;
- •4) At least one measurable lesion according to RECIST1.1 criteria;
- •5) Availability of a tumor sample (primary and/or metastatic sites)
- •for exploratory research;
- •6) Age = 18 years;
- •7) ECOG PS = 2;
- •8) Life expectancy of at least 12 weeks;
- •9) Previous adjuvant chemotherapy allowed only if more than 6
- •months elapsed between the end of adjuvant and first relapse;
- •10) Neutrophils = 1.5 x 109/L, Platelets =100 x 109/L, Hgb = 9 g/dl;
- •11) 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);
- •12) Creatinine clearance =50 mL/min or serum creatinine = 1.5 x
- •13) Female with a childbearing potential and male subjects must be
- •willing to use adequate contraception (barrier contraceptive
- •measure, oral contraception, intrauterine device);
- •14) Will and ability to comply with the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
Exclusion Criteria
- •1) Previous treatment for metastatic disease;
- •2) Radiotherapy to any site within 4 weeks before the study;
- •3) Any contraindication to use Panitumumab, Irinotecan, 5-FU or
- •folinic acid
- •4) Known or clinically suspected brain metastases.
- •5) History or evidence upon physical examination of CNS disease
- •unless adequately treated.
- •6) Ascites, pleural effusion or pericardial fluid requiring drainage in
- •last 4 weeks.
- •7) Diagnosis of interstitial pneumonitis or pulmonary fibrosis;
- •8) 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;
- •9) 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;
- •10) Treatment with any investigational drug within 30 days prior to
- •11) 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;
- •12) 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.
- •13) Disease that is deemed potentially resectable.
- •14) Known hypersensitivity to trial drugs or hypersensitivity to any
- •other component of the trial drugs.
- •15) Any concomitant drugs contraindicated for use with the trial
- •drugs according to the product information of the pharmaceutical
- •16) Breastfeeding
Investigators
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