Chemotherapy + Radiation Therapy for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

Eugene J. Koay | MD Anderson Cancer Center

Overseen byEugene J. Koay

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a phase II study using the Bayesian platform design. There are three clinical stage groups of localized pancreatic cancer: resectable, borderline resectable, and locally advanced disease. Each stage group will have a defined standard of care chemotherapy regimen for a control arm, serving as a basis of comparison. Each group may have one or more experimental arms. Experimental arms may be added to the platform over time, and the effects of the experimental treatments will be tested against the controls for each group.

Research Team

Eugene J. Koay

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Adults with resectable, borderline resectable, or locally advanced pancreatic cancer. Must not be pregnant/nursing and have a life expectancy over 6 months. Eligible participants need normal organ function (blood counts, liver/kidney tests within certain limits) and no prior treatments for those treatment-naive or only specific past chemotherapies for the previously treated.

Inclusion Criteria

Previously Treated Resectable PDAC Cohort: Creatinine =< 1.5 x upper limit of normal (ULN)

My white blood cell count is high enough for treatment.

My kidneys work well enough (creatinine clearance over 45 mL/min).

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Exclusion Criteria

I do not have serious heart rhythm problems.

I have a cancer other than basal cell carcinoma that hasn't been treated yet.

My pancreatic cancer was not just in the pancreas when diagnosed.

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Treatment Details

Interventions

Cisplatin (Alkylating agents)
Fluorouracil (Antimetabolites)
Gemcitabine (Antimetabolites)
Irinotecan (Topoisomerase I inhibitors)
Leucovorin (Antimetabolites)
Nab-paclitaxel (Taxane)
Oxaliplatin (Alkylating agents)
Radiation Therapy (Radiation)

Trial OverviewThe PIONEER-Panc study is testing various chemotherapy drugs (Cisplatin, Irinotecan, Oxaliplatin, Leucovorin, Fluorouracil) and Nab-paclitaxel plus Gemcitabine against standard care in different stages of pancreatic cancer using a phase II Bayesian platform design to determine their effectiveness.

Participant Groups

6Treatment groups

Active Control

Group I: Control arm GroupI(mFOLFIRINOX)Active Control4 Interventions

Patients receive mFOLFIRINOX for 3 months before and after surgery in the absence of disease progression or unacceptable toxicity.

Group II: Control arm GroupII(chemotherapy, FOLFIRINOX)Active Control7 Interventions

Patients receive gemcitabine, gemcitabine and nab-paclitaxel, gemcitabine and cisplatin, or FOLFIRINOX for up to 4 months in the absence of disease progression or unacceptable toxicity.

Group III: Control arm GroupIII(FOLFIRINOX, radiation therapy)Active Control5 Interventions

Patients receive FOLFIRINOX for 4-6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors.

Group IV: Control arm GroupVI(chemotherapy,FOLFIRINOX,radiation therapy)Active Control8 Interventions

Patients receive gemcitabine, gemcitabine and nab-paclitaxel, gemcitabine and cisplatin, or FOLFIRINOX for 6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors

Group V: Control arm GroupIV(chemotherapy,FOLFIRINOX,radiation therapy)Active Control8 Interventions

Group VI: Control arm GroupV(FOLFIRINOX, radiation therapy)Active Control5 Interventions

Patients receive FOLFIRINOX for 4-6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors

Cisplatin is already approved in Canada, Japan for the following indications: