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

Phase 1

• Conditions: patients with RAS/B-RAF wild-type metastatic colorectal cancer; MedDRA version: 21.0Level: PTClassification code 10052360Term: Colorectal adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-003628-65-IT
• Lead Sponsor: ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-06
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

1)Written informed consent to study procedures and to molecular
analyses;
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
UNL;
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
enrolment;
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
companies.
16) Breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified