Status:
UNKNOWN
Trial of FOLF(HA)Iri With Cetuximab in mCRC
Lead Sponsor:
Western General Hospital, Australia
Collaborating Sponsors:
Alchemia Oncology
Merck Serono International SA
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
As an approach to improve efficacy and provide clinical benefit to cancer patients undergoing chemotherapeutic treatment regimens, Alchemia Oncology has developed a novel means for delivering anti-can...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2016
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02216487
Start Date
June 1 2014
End Date
November 1 2016
Last Update
August 29 2014
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Liverpool Hospital
Sydney, New South Wales, Australia, 1871
2
Southern Medical Day Care Centre
Wollongong, New South Wales, Australia, 2500
3
Western General Hospital
Melbourne, Victoria, Australia, 3021