Gemcitabine+Nab-paclitaxel and FOLFIRINOX and Molecular Profiling for Patients With Advanced Pancreatic Cancer

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The Investigators in the PCRT team have developed a therapeutic regimen which attacks both the tumor compartment and the stromal compartment of pancreatic cancer and induces complete responses in a small percentage of patients with advanced stage IV pancreatic cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pancreatic Cancer Research Team
• Treatments: Albumin-Bound Paclitaxel; Folfirinox; Gemcitabine; Metformin; Paclitaxel

Criteria

Inclusion Criteria:

• Histologically documented Stage IV metastatic adenocarcinoma of the pancreas with measurable disease

• Performance status ECOG 0 or 1

• Patients may not have received prior treatment for metastatic pancreatic adenocarcinoma except for receiving gemcitabine or 5FU as a radiosensitizer along with radiation therapy; or have received gemcitabine for adjuvant treatment if they have been off gemcitabine for > 12 months

• Adult (>18 years of age) male or non-pregnant and non-lactating female

• A negative serum pregnancy test (Beta-hCG) documented within 72 hours of the first administration of study drug in female patients of child-bearing potential

• Agreement to use contraception considered adequate and appropriate by the investigator

• The following blood counts at baseline:

• ANC >/= 1.5 x 109/L

• Hgb > 9g/dL

• Platelets >100 x 109/L

• The following blood chemistry levels at baseline:

• AST and ALTmetastasis are present

• Bilirubin
• Serum creatinine within 1.5 x ULN

• PT, INR within 1.5 x ULN unless on therapeutic doses of warfarin

• Must have measurable disease outside the pancreas by RECIST criteria

• No clinically significant abnormalities in urinalysis results

• Voluntary agreement to participate in this study after being informed about the nature of the study including potential risks and benefits and having the ability to have questions addressed. The patient must sign and date the IRB approved Informed Consent Form (ICF) prior to participation in any study-related procedures

Exclusion Criteria:

• Has pancreatic islet cell neoplasms

• Is pregnant or lactating

• Has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy

• Known infection with HIV, Hepatitis B or Hepatitis C.

• Patient with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies (see section 4.4.9)

• Has a serious medical risk factor(s) involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.

• Is unwilling or unable to comply with study procedures.

• Is enrolled in any other investigational trial.

Caution of observation for interstitial pneumonitis in patients prior to enrollment:

Before enrollment, evaluate candidate patients fro familial, environmental or occupational exposure to opportunistic pathogens, and do not enroll those with a history of slowly progressive dyspnea and unproductive cough, or of conditions such as sarcoidosis, silicosis. idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies.