EUCTR2012-003638-18-ESActive, not recruitingPhase 1
Randomised Phase II study of cetuximab alone or in combination with irinotecan in patients with metastatic CRC with either KRAS WT or G13D mutation. ICE CREAM: The Irinotecan Cetuximab Evaluation and the Cetuximab Response Evaluation Among Patients with G13D Mutation - ICE CREAM: AG0112CR
Australasian Gastro-Intestinal Trials Group, Sydney University0 sites100 target enrollmentStarted: December 20, 2012Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •1. Males or females with histologically confirmed colorectal cancer;
- •2. Age more than 18 yrs;
- •3. Metastatic disease not amenable to complete resection;
- •4. Measurable or evaluable disease as assessed by CT scan of the chest, abdomen and pelvis as per the RECIST v1.1 criteria;
- •5. Prior confirmation of tumour KRAS status as either KRAS WT (with no mutations or changes in BRAF, NRAS, PIK3CA exon20) OR KRAS G13D mutation,
- •6. ECOG performance status of 0-2;
- •7. Received and progressed on, or intolerant of all therapies listed below: (failure is defined as radiological progression during therapy, or toxicity limiting further therapy, or progression within 6 months of adjuvant treatment)
- •- thymidylate synthase inhibitor
- •- irinotecan-containing regimen
- •- oxaliplatin-containing regimen, OR have documented unsuitability for an oxaliplatin-containing regimen;
- •8. Adequate haematological and renal function;
- •9. Adequate liver function;
- •10. Life expectancy of at least 12 weeks;
- •11. Study treatment both planned and able to start within 14 days of randomisation;
- •12. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments;
- •13. Signed, written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 7
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
Exclusion Criteria
- •1. Prior treatment with cetuximab or other drugs targeting the EGFR pathway;
- •2. Severe restrictive lung disease or radiological pulmonary findings;
- •3. Brain metastases that are either untreated, symptomatic, or which have not been stable for at least one month after treatment;
- •4. History of another malignancy within 5 years prior to registration (exception of treated cervical carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder)
- •5. Severe or uncontrolled cardiovascular disease;
- •6. Concurrent illness;
- •7. Presence of any psychological, familial, sociological or geographical condition;
- •8. Pregnancy, lactation, or inadequate contraception.
Investigators
Similar Trials
Active, not recruiting
Phase 1
A study to explore the effects of cetuximab alone or in combination with irinotecan in patients with an abnormal gene (KRAS) in their colon cancer cells.metastatic colorectal cancerEUCTR2012-003638-18-BEAustralasian Gastro-Intestinal Trials Group, Sydney University100
Active, not recruiting
Not Applicable
A study to explore the effects of cetuximab alone or in combination with irinotecan in patients with an abnormal gene (KRAS) in their colon cancer cells.EUCTR2012-003638-18-GBAustralasian Gastro-Intestinal Trials Group, Sydney University100
Active, not recruiting
Phase 1
ICE CREAM: The Irinotecan Cetuximab Evaluation and the Cetuximab Response Evaluation Among Patients with G13D MutatioEUCTR2012-003638-18-ITAGITG (Australasian Gastro - Intestinal Trial Group)100
Active, not recruiting
Not Applicable
Randomised phase II study of cetuximab in combination with gemcitabine or gemcitabine followed by cetuximab in patients with advanced non-small-cell lung cancer, not suitable for standard platin-based therapyPatients with advanced non-small-cell lung cancer, not suitable for standard platin-based therapy.MedDRA version: 6.1Level: PTClassification code 10061873EUCTR2004-002811-98-ITISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE100
Active, not recruiting
Phase 1
Randomized phase II feasibility study of cetuximab combined with 4 cycles of TPF followed by platinum based chemo-radiation strategies - NDEUCTR2006-004189-14-ITE.O.R.T.C. - EUROPEAN ORGANIZATION FOR RESEARCH AND TREATMENT OF CANCER