Status:
UNKNOWN
Study of Trastuzumab-emtansine in Patients With HER2-positive Metastatic Colorectal Cancer Progressing After Trastuzumab and Lapatinib.
Lead Sponsor:
Fondazione del Piemonte per l'Oncologia
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a phase II, open label, multicenter study. Patients with advanced colon rectal cancer (CRC) harboring an amplified HER2 that have been previously treated and progressed with an aNti-HER2 treat...
Detailed Description
In metastatic colorectal cancer, HER2 amplified patients relapsing after initial long-lasting response to the anti HER combination of trastuzumab + lapatinib, HER2 gene amplification, and the ensuing ...
Eligibility Criteria
Inclusion
- Histological/confirmed adenocarcinoma of the colon or rectum with metastatic disease not amenable to salvage surgery.
- Progression (PD) during or after therapy with anti-HER2 therapy including those in HERACLES trial cohort A (trastuzumab and lapatinib) within the HERACLES - A trial.
- ECOG PS \< 2
- Measurable disease as defined by RECIST 1.1 criteria
- Adequate hematological function as defined by: ANC \>= 1.5 x 10\^9/L, platelet count \>=100 x 10\^9/L, hemoglobin \>= 10 g/dL.
- Adequate renal function, as defined by: creatinine \>= 1.5 x UNL
- Adequate hepatobiliary function, as defined by the following baseline liver function tests:
- total serum bilirubin \>=1.5 upper normal limit (UNL) (unless documented Gilbert's syndrome )
- alanine aminotransferase (ALT), aspartate aminotransferase (AST) \>= 2.5xUNL
- alkaline phosphatase (AP) \>= 2.5xUNL; if total alkaline phosphatase (AP) \> 2.5xUNL, alkaline phosphatase liver fraction must be \>= 2.5xUNL
- Adequate contraception for all fertile patients
- Negative pregnancy test.
Exclusion
- Symptomatic brain metastases
- Active infection
- Interval from last anti HER2 therapy \< 2 weeks. Patients in treatment with T-DM1 (provided by third-parties) may be eligible for immediate treatment if not in progression at the time of protocol entry.
- Prior chemotherapy \<4 weeks.
- Impaired cardiac function including any of the following: uncontrolled hypertension (systolic \>150 mmHg and/or diastolic \> 100 mmHg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident/stroke or myocardial infarction within 6 months prior to first study medication; unstable angina; chronic heart failure (CHF) of New York Heart Association (NYHA) Grade II or higher; or serious cardiac arrhythmia requiring medication, baseline Left Ventricular Ejection Fraction (LVEF) ≤ 55% measured by echocardiography (ECHO)
- Major surgery in the two weeks prior to entering the clinical trial
- Concurrent treatment with any other anti-cancer therapy
- Patient unable to comply with the study protocol owing to psychological, social or geographical reasons
- Pregnant and lactating women
- Men and women of childbearing potential who are not using an effective method of contraception
- Participation in another clinical trial
- Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
Key Trial Info
Start Date :
July 8 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2019
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03418558
Start Date
July 8 2015
End Date
June 1 2019
Last Update
October 31 2018
Active Locations (3)
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1
Fondazione del Piemonte per l'Oncologia
Candiolo, Italy, 10060
2
Grande Ospedale Metropolitano Niguarda
Milan, Italy
3
IOV - Istituto Oncologico Veneto
Padua, Italy