ACTRN12612000777897
Completed
Phase 2
A phase II trial assessing feasibility of personalised treatment based on specified tumour molecular signatures (phenotypes) of the tumour in patients with recurrent or metastatic pancreatic cancer.
The Australasian Gastro-Intestinal Trials Group (AGITG)0 sites10 target enrollmentJuly 23, 2012
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Advanced (metastatic or recurrent) pancreatic cancer
- Sponsor
- The Australasian Gastro-Intestinal Trials Group (AGITG)
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adult males or females 18 years or over with histologically confirmed primary adenocarcinoma of the pancreas who have cytological confirmation of recurrent or metastatic disease
- •2\. Are currently enrolled in APGI and have consented through APGI to notify them if something of significance in regards to their cancer is found.
- •3\. One of the following specified three molecular signatures:
- •\*HER2 positive (HER2/neu over expression) subgroup; assessed using detailed DNA sequencing and RNA expression analysis and confirmed by HER2 ISH testing (using standard gastric cancer protocols).
- •\*Homologous recombinant defects (BRCA1/BRCA2 or PALB2 mutation\*) subgroup; assessed using detailed DNA sequencing and confirmed by PCR.
- •\*antiEGFR responsive (KRAS WT or KRAS codon 13 mutation) subgroup; assessed using detailed DNA sequencing and confirmed by PCR (using standard colorectal cancer protocols).
- •(\* While variants of BRCA1, BRCA2 and PALB2 will be detected in the APGI study, only pathological mutations will be included in the homologous recombinant defects phenotype)
- •4\. For HER2 positive patients adequate cardiac function, defined as Left Ventricular Ejection fraction (LVEF) which equals 50% or above the ULN for the institution (whichever is lower). Cardiac function should be assessed within 3 months prior to registration;
- •5\. Have a life expectancy of over 3 months;
- •6\. Performance status of ECOG 0\- 2;
Exclusion Criteria
- •1\. Contraindications to any study treatments;
- •2\. Prior systemic treatment for recurrent / metastatic disease except for patients with the HER2 positive or antiEGFR responsive target molecular signature. In patients with these molecular signatures, up to one cycle of standard dose gemcitabine \+/\- abraxane chemotherapy commenced within 5 weeks prior to registration to the study. (For patients receiving an initial cycle of gemcitabine \+/\- abraxane, they must be considered still suitable for ongoing chemotherapy at standard doses by their responsible clinician.
- •3\. Patients who have received neoadjuvant or adjuvant chemotherapy with gemcitabine \+/\- abraxane, including chemoradiation, following surgical resection of pancreatic cancer and completed treatment within the last 6 months, unless further treatment with gemcitabine or abraxane is appropriate in the opinion of the treating clinician;
- •4\. Untreated brain metastases or leptomeningeal disease. Patients with brain metastases that have been treated, and are asymptomatic, and have been stable for 3 or more months after treatment are allowed. A baseline CT brain or MRI is only required if there is clinical suspicion of central nervous system involvement;
- •5\. History of another malignancy within 5 years prior to registration. Patients with a past history of adequately treated carcinoma\-in\-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, curatively treated cervical carcinoma in situ or non\-melanomatous carcinoma of the skin or superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 5 years after definitive primary treatment;
- •6\. Any significant active infection, including chronic active hepatitis B, hepatitis C, or HIV. Testing for these is not mandatory unless clinically indicated. Patients with known Hepatitis B/C infection will be allowed to participate providing evidence of viral suppression has been documented and the patient remains on appropriate anti\-viral therapy;
- •7\. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol;
- •8\. Pregnancy, lactation, or inadequate contraception. Women must be post menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 14 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.
Outcomes
Primary Outcomes
Not specified
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