Trial of FOLF(HA)Iri With Cetuximab in mCRC
Keywords
Abstract
Dates
| Last Verified: | 07/31/2014 |
| First Submitted: | 08/11/2014 |
| Estimated Enrollment Submitted: | 08/11/2014 |
| First Posted: | 08/14/2014 |
| Last Update Submitted: | 08/26/2014 |
| Last Update Posted: | 08/28/2014 |
| Actual Study Start Date: | 05/31/2014 |
| Estimated Primary Completion Date: | 05/31/2016 |
| Estimated Study Completion Date: | 10/31/2016 |
Condition or disease
Intervention/treatment
Drug: HA-Irinotecan
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: HA-Irinotecan HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan. | Drug: HA-Irinotecan HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan for treatment of mCRC. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion criteria - Tumour is KRAS wild type - mCRC with disease progression after first-line chemotherapy (adjuvant chemotherapy is considered first line chemotherapy if metastatic progression occurs within 6 months of the end of the adjuvant chemotherapy). - Irinotecan naïve - Prior use of bevacizumab in the 1st line setting is permitted. - ECOG 0 or 1 - Measurable disease - Histological proof of colorectal adenocarcinoma - 18+ years of age - Adequately recovered from and at least 4 weeks after recent major surgery or chemotherapy - At least 4 weeks after treatment with a biologic monotherapy from last dose to enrolment. - Hematology done within 14 days prior to enrolment : - Absolute Neutrophil count (ANC) greater than 1.5 x 109/L - Platelets greater than 100 x 109/L - Hemoglobin greater than or equal to 100g/L - Chemistry done within 14 days prior to enrolment: - AST greater than or equal to 2.5 X ULN (greater than 5 X ULN if elevation thought to be related to hepatic metastatic disease), - Alkaline phosphatase greater than 5 x ULN, - Serum creatinine greater than 1.5 x ULN, - Total bilirubin greater than 34.2 µmol/L, - Negative serum or urine pregnancy test if a WOCBP. Exclusion criteria - KRAS mutant. - Prior irinotecan - Prior anti-EGFR - History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for greater than 5 years. - Locally advanced or recurrent disease only - Unsuitability for irinotecan - Abdominal or pelvic radiation therapy (including treatment with SIR-Spheres/Sirtex) within the last 12 months. - Women who are pregnant or breastfeeding. - Significant cardiac disease - Untreated or symptomatic brain or central nervous system (CNS) metastases - Presence of pleural effusion or ascites requiring therapeutic thoracocentesis or paracentesis. - Current partial or complete bowel obstruction. - Concomitant active infection. |
Outcome
Primary Outcome Measures
1. Safety [2 years]
