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Anti-metabolites

Adaptive Neoadjuvant Chemotherapy for Pancreatic Cancer (PANCREAS Trial)

Phase 2

Recruiting

Led By Kathleen K Christians, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have documentation of histologically confirmed adenocarcinoma. Biopsy must have been completed prior to start of treatment Have an Eastern Cooperative Group (ECOG) performance status < 2 (please see the appendix).

Have clinical stage consistent with resectable or borderline resectable adenocarcinoma of the pancreas, based on CT or MRI findings.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial is testing a new cancer treatment in patients with resectable or borderline resectable pancreatic cancer.

Who is the study for?

This trial is for adults with resectable or borderline resectable pancreatic cancer. Participants must have confirmed adenocarcinoma, an ECOG performance status less than 2 (meaning they are able to carry out all self-care but unable to carry out any work activities), and adequate organ/bone marrow function. They need a CA19-9 level above 35 mg/dL and must understand the study well enough to give informed consent.

What is being tested?

The study tests two chemotherapy regimens: mFOLFIRINOX and Gemcitabine/Nab-paclitaxel, along with chemoradiation in patients with operable pancreatic cancer. It's a phase II trial where doctors will adapt treatment based on RNA expression profiles from biopsy samples taken through endoscopic ultrasound (EUS).

What are the potential side effects?

Common side effects of these treatments may include nausea, vomiting, diarrhea, fatigue, decreased blood cell counts leading to increased infection risk or bleeding problems, hair loss, and potential nerve damage that can cause pain or numbness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is confirmed as adenocarcinoma and I can do most daily activities.

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My pancreatic cancer is at a stage where surgery might be possible.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Subjects who receive PurIST classification-directed therapy.

Secondary study objectives

Subjects with basal subtype tumors who complete all intended neoadjuvant therapy and surgical therapy.

Subjects with classical subtype tumors who complete all intended neoadjuvant therapy and surgical therapy.

Treatment response for subjects with basal subtype tumors.

+1 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

8Treatment groups

Experimental Treatment

Group I: Subtype diagnosis and classification: ClassicalExperimental Treatment1 Intervention

Patients will be classified by (molecular) subtype (using the PurIST classifier) into two groups: basal and classical pancreatic cancer. Patients in the classical group will receive two months of the mFOLFIRINOX Treatment Regimen.

Group II: Subtype diagnosis and classification: BasalExperimental Treatment1 Intervention

Patients will be classified by (molecular) subtype (using the PurIST classifier) into two groups: basal and classical pancreatic cancer. Upon diagnosis, patients categorized as basal will receive two months of the Gemcitabine/Nab-paclitaxel Treatment Regimen.

Group III: Classical Group: Restaging: Response to TreatmentExperimental Treatment1 Intervention

After the first restaging evaluation, further treatment will be based on treatment response. Patients who demonstrate a response \[decline in carbohydrate antigen 19-9 (CA19-9) values\] and radiographic response, along with preserved performance status) will be maintained on the first line chemotherapy for an additional two months.

Group IV: Classical Group: Restaging: Patients with Stable DiseaseExperimental Treatment1 Intervention

Patients who do not have a significant decline in CA19-9 values will be changed to a second-line therapy for an additional two months.

Group V: Classical Group: Restaging: Local Disease ProgressionExperimental Treatment1 Intervention

Further treatment will be based on treatment response. If the patient has local disease progression amenable to surgical resection, he or she will receive chemoradiation, rather than continued chemotherapy, so the window of opportunity for surgical resection is not lost.

Group VI: Basal Group: Restaging: Response to TreatmentExperimental Treatment1 Intervention

Group VII: Basal Group: Restaging: Patients with Stable DiseaseExperimental Treatment1 Intervention

Patients who do not have a significant decline in CA19-9 values will be changed to a second-line therapy for an additional two months.

Group VIII: Basal Group: Restaging: Local Disease ProgressionExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Chemoradiation

2006

Completed Phase 3

~990