Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
45 participants
INTERVENTIONAL
2014-06-30
2016-11-30
Brief Summary
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The current study is an investigation into the use of HA-Irinotecan in a Phase II single arm trial of FOLF(HA)iri plus cetuximab in irinotecan-naïve second line patients with KRAS wild type metastatic colorectal cancer. The study objectives are to confirm the safety and efficacy of FOLF(HA)iri plus cetuximab as second-line therapy in irinotecan-naïve metastatic colorectal cancer patients.
It is expected that the study recruit approximately 40-50 patients in 1 year with subsequent treatment and follow up; thus the trial will run for approximately 2-3 years.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HA-Irinotecan
HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan.
HA-Irinotecan
HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan for treatment of mCRC.
Interventions
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HA-Irinotecan
HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan for treatment of mCRC.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Alchemia Oncology
INDUSTRY
Merck Serono International SA
INDUSTRY
Western General Hospital, Australia
OTHER
Responsible Party
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Peter Gibbs
Associate Professor
Principal Investigators
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Peter Gibbs, MD
Role: PRINCIPAL_INVESTIGATOR
Western General Hospital
Locations
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Liverpool Hospital
Sydney, New South Wales, Australia
Southern Medical Day Care Centre
Wollongong, New South Wales, Australia
Western General Hospital
Melbourne, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Peter Gibbs, MD
Role: primary
Other Identifiers
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ACO-004
Identifier Type: -
Identifier Source: org_study_id