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Chemotherapy

Adaptive Neoadjuvant Chemotherapy for Pancreatic Cancer (PANC Trial)

Phase 2

Recruiting

Led By Kathleen 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; additional biopsy is not required for the study.

Have adequate organ and bone marrow function as defined by: total leukocytes >3 x10^3/μL, absolute neutrophil count (ANC) >1.5x 10^3/μL, hemoglobin >9 g/dL, platelets >100 x 10^3/μL, creatinine clearance >60 mL/min or creatinine <1.5 mg/dL, bilirubin < 2 mg/dL, aspartate transaminases (AST/SGOT) and alanine transaminases (ALT/SGPT) <3 x upper limit of normal (ULN).

Must not have

No documentation of a CA19-9 value when total bilirubin < 2 prior to initiation of chemotherapy.

Has received any additional chemotherapy and/or radiation within three years prior to study enrollment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up five years.

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial is testing a new treatment for people with pancreas cancer that has not spread.

Who is the study for?

Adults with confirmed pancreatic adenocarcinoma that's resectable or borderline so, who haven't had extensive prior treatments and are in fairly good health (ECOG <2). They must have certain blood and organ function levels, not be pregnant or breastfeeding, use contraception if of childbearing potential, and can't have HIV/HBV/HCV or other serious conditions.

What is being tested?

This phase II trial is testing how well patients respond to different sequences of chemotherapy and chemoradiation before surgery. It's open-label, meaning everyone knows which treatment they're getting. The goal is to find the best approach for shrinking tumors pre-surgery.

What are the potential side effects?

Chemotherapy and chemoradiation may cause nausea, vomiting, fatigue, hair loss, low blood cell counts leading to increased infection risk or bleeding problems. There might also be liver issues due to medication toxicity.

Eligibility Criteria

Inclusion Criteria

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

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My cancer diagnosis was confirmed through a biopsy.

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My blood and organ tests meet the required levels for treatment.

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I can do most of my daily activities without help.

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I am 18 years old or older.

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

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My CA19-9 levels are high, but my bilirubin is low.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had a CA19-9 test done before starting chemotherapy when my bilirubin was low.

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I have had chemotherapy or radiation in the last 3 years.

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I have HIV, HBV, or HCV.

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I have had another type of cancer in the last 3 years.

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I have been treated with FOLFIRINOX or mFOLFIRINOX for over two months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ five years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~five years

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

Treatment Details

Study Objectives

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

Primary study objectives

Completion of all intended neoadjuvant therapy and surgical therapy

Secondary study objectives

Overall survival

Progression-free survival

Side effects data

From 2013 Phase 3 trial • 688 Patients • NCT00424255

63%

Mucosal inflammation

52%

Nausea

48%

Rash

44%

Vomiting

42%

Diarrhoea

42%

Dry mouth

36%

Dysphagia

26%

Weight decreased

25%

Lymphopenia

24%

Leukopenia

22%

Anaemia

20%

Neutropenia

18%

Pyrexia

18%

Decreased appetite

17%

Constipation

17%

Asthenia

16%

Radiation skin injury

14%

Stomatitis

13%

Cough

13%

Oropharyngeal pain

13%

Blood creatinine increased

12%

Odynophagia

12%

Skin reaction

12%

Fatigue

12%

Hypokalaemia

Hyponatraemia

Haemoglobin decreased

Dysgeusia

White blood cell count decreased

Alanine aminotransferase increased

Aspartate aminotransferase increased

Dyspepsia

Creatinine renal clearance decreased

Dysphonia

Pruritus

Productive cough

Oral pain

Thrombocytopenia

Lymphocyte count decreased

Headache

Neck pain

Oral candidiasis

Insomnia

Radiation mucositis

Musculoskeletal pain

Ejection fraction decreased

Pneumonia

Dehydration

Epistaxis

Oesophageal stenosis

Hepatic enzyme increased

Pharyngeal fistula

Hyperkalaemia

Acute respiratory failure

Mouth haemorrhage

Wound infection

Febrile neutropenia

General physical health deterioration

Hyperuricaemia

Malnutrition

Hypocalcaemia

Feeding disorder

Sepsis

Lung abscess

Oral infection

Blood uric acid increased

Dyspnoea

Pneumonia aspiration

Tracheostomy malfunction

Cerebral ischaemia

Renal failure

Renal impairment

Hyperbilirubinaemia

Depression

Death

Left ventricular dysfunction

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Lapatinib 1500 mg

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

3Treatment groups

Experimental Treatment

Group I: 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 II: 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 III: Restaging: Local Disease ProgressionExperimental Treatment1 Intervention

After the first restaging evaluation, further treatment will be based on treatment response. If, at the initial restaging, 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Chemoradiation

2006

Completed Phase 3

~990

0 / 11Eligibility criteria met