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A randomised phase II study evaluating Dual inhibition of epidermal growth factor receptor (EGFR) signalling using CetUXimab and Erlotinib or dose escalated Cetuximab in patients with chemotherapy refractory KRAS wild-type metastatic colorectal cancer

ABSTRACT: Interventions: Patients randomised to treatment Arm B will receive dual EGFR inhibition, consisting of Cetuximab 400mg/m2 (initial dose), then 250mg/m2 via intravenous infusion each week, plus Erlotinib 100mg via oral tablet(s) daily continuously. Patients randomised to treatment Arm C will receive high-dose Cetuximab, 500mg/m2 via intravenous infusion each week. Treatment will continue until disease progression, unacceptable toxicity (as defined in the protocol), patient and/or clinician preference, or patient death. Patients participating in the optional skin management study randomised to Group 1 will commence pre-emptive skin side effect treatments the day before starting study Cetuximab, and will continue until study treatment is ceased. Patients will be required to adhere to: daily use of moisturiser and topical 1% hydrocortisone (steroid) applied to face, hands, feet, neck, back each day; use of sunscreen before sun exposure; and taking doxycycline (antibiotic) 100mg via oral tablet(s) twice each day. Primary outcome(s): Tumour response rate, as assessed by RECIST v.1.1 using chest, abdomen and pelvis CT.[Baseline, 6-weekly while on treatment then 3-monthly for 12 months of follow-up. RECIST assessments cease for completion of follow-up, study withdrawal, progressive disease, new anti-cancer therapy or patient death.] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy

DISEASE(S): Metastatic Colorectal Cancer,Skin-other Skin Conditions,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Egfr Inhibitor Induced Skin Toxicity

PROVIDER: 2457580 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Combination treatment using cetuximab, cobimetinib and palbociclib. This is a two part open label study using escalating doses of these drugs. Phase 1 will enroll 3-6 patients in one of 6 Cohorts, for dose escalation. The initial dose escalation will start at cetuximab 150mg/m2 intravenously (IV) + cobimetinib 20 mg orally once daily (po qd) + palbociclib 50mg orally once daily (po qd), for Cohort 1. Cohort 2 = cetuximab 150mg/m2 IV + cobimetinib 20 mg po qd + palbociclib 75mg po qd. Cohort 3 = cetuximab 150mg/m2 IV + cobimetinib 40 mg po qd + palbociclib 75mg po qd. Cohort 4 = cetuximab 150mg/m2 IV + cobimetinib 60 mg po qd + palbociclib 75mg po qd. Cohort 5 = cetuximab 200mg/m2 IV + cobimetinib 60 mg po qd + palbociclib 75mg po qd. Cohort 6 = cetuximab 250mg/m2 IV + cobimetinib 60 mg po qd + palbociclib 100mg po qd. Cetuximab will be administered weekly via intravenous infusion. Cobimetinib will be taken orally once daily for the first 21 consecutive days in a 28 day treatment cycle. Cobimetinib will be taken in tablet form. Palbociclib will be taken orally once daily for first 21 consecutive days in a 28 day treatment cycle. Palbociclib will be taken in capsule form. Neither of these two drugs will be given in the last 7 days of this 28 day cycle. Cohorts of 3 patients will be enrolled at each dose level (with the option of up to six patients for each cohort if necessary) to assess toxicity. Each patient will participate in only one cohort to determine dose limiting toxicities of the combination. Patients at each dose level will be treated and observed through the end of the first cycle before treatment of subjects at the next higher dose level can begin. Cohorts 1 to 6 will randomly assign consecutive patien Primary outcome(s): Phase 1: Determination of Dose Limiting Toxicity (DLT). A DLT will be defined using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) v 5.0 [Phase 1 DLTs will be assessed during the first cycle of treatment (28 days) and are events that are considered possiby related to the study drug combination for each cohort. After the treatment of each cohort, data will be reviewed to assess patient status and study drug related toxicities from the current cohort before deciding the escalation plan and dose level for the next cohort. ];Phase 2: Determination of Objective Response Rate as determined by MRI scanning with RECIST criteria reporting[Phase 2: patients will be reviewed for objective response rate after at least 2 treatment cycles] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Other;Type of endpoint: Safety

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A randomised phase II study evaluating Dual inhibition of epidermal growth factor receptor (EGFR) signalling using CetUXimab and Erlotinib or dose escalated Cetuximab in patients with chemotherapy refractory KRAS wild-type metastatic colorectal cancer

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