Pancreatic Cancer
Conditions
Brief summary
Single compassionate use subject is an 83 year old woman with a history of lymph node positive breast cancer and recently diagnosed pancreatic cancer in May. With an Eastern Cooperative Oncology Group (ECOG) of 2, it is felt that she cannot tolerate more aggressive chemotherapy. The investigators propose to administer FG-3019 on a compassionate pleas basis in combination with gemzar. The patient is currently being treated and is tolerating gemzar.
Detailed description
The FG-3019 treatment will be administered over a 28-day cycle: * Dose: 35 mg/kg * Route: IV over one hour following completion of gemcitabine infusion * Schedule: * Days 1, 8, and 15 * Please note that Day 8 infusion will on be completed during the first treatment cycle On Drug Evaluation The patient will be seen prior to every FG-3019 treatment by the treating physician. The following procedures will be conducted at each visit: * History and thorough symptom assessment * Physical examination * Laboratory assessments (these can be collected up to 3 days prior to treatment): * Complete blood count (CBC) and differential * Comprehensive Metabolic Panel (Chemistry): bicarbonate, blood, urea, nitrogen (BUN), calcium, creatinine, glucose, potassium, sodium * Liver Function Tests: Alkaline phosphatase (ALP), Alanine transaminase (ALT), Aspartate transaminase (AST), total bilirubin * Carbohydrate antigen (CA) 19-9 ECGs will be conducted during the screening and end of treatment visits. CT scans of the chest and abdomen will be done every 12 to 16 weeks. All of these data will be recorded and stored with their source documents.
Interventions
DRUGFG-3019
The FG-3019 treatment will be administered over a 28-day cycle: * Dose: 35 mg/kg * Route: IV over one hour following completion of gemcitabine infusion * Schedule: * Days 1, 8, and 15 * Please note that Day 8 infusion will on be completed during the first treatment cycle
Sponsors
Jonsson Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
83 Years to 83 Years
Healthy volunteers
No
Inclusion criteria
* Signed Consent form * Have adequate liver function * Have adequate bone marrow function
Exclusion criteria
* History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies * Any medical or surgical condition that may place the subject at increased risk while on treatment * Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with treatment requirements * Current abuse of alcohol or drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FG-3019 treatment regimen to increase OS (overall survival) | 7.7 months |
Outcome results
None listed