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Anti-metabolites

Perioperative Chemotherapy for Pancreatic Cancer

Phase 3

Recruiting

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

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

Must have

Less than 180 degree interface between tumor and vessel wall of the portal vein or superior mesenteric vein, and patent portal vein/splenic vein confluence

TNM Stage: Tx-4, N0-1, M0 (M0 disease does not include spread to distant lymph nodes and organs)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time between randomization and death from any cause, assessed up to 6 years.

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery.

Who is the study for?

This trial is for adults with removable pancreatic cancer who have not had prior treatments. They must have normal bilirubin and creatinine levels or adequate kidney function, no severe liver conditions like Gilbert's Syndrome, and be fit for surgery. Pregnant or nursing women can't join, nor those on certain drugs affecting the liver enzyme CYP3A4. Participants need to be in good physical condition (ECOG 0-1) with minimal nerve damage from neuropathy.

What is being tested?

The study compares two approaches using chemotherapy drugs fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin: one where patients receive chemo before and after surgery (perioperative), versus only after surgery (adjuvant). The goal is to see which method is more effective at treating pancreatic cancer that can be surgically removed.

What are the potential side effects?

Possible side effects of the chemotherapy may include nausea, vomiting, diarrhea, fatigue, hair loss, decreased blood cell counts leading to increased infection risk or bleeding problems. Nerve damage causing numbness or tingling in hands and feet might also occur.

Eligibility Criteria

Inclusion Criteria

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

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My tumor partially touches the blood vessels near my liver or intestine but hasn't blocked them.

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My cancer has not spread to distant parts of my body.

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I have not had any treatment for pancreatic cancer.

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My kidney function, measured by creatinine levels or clearance, is within the required range.

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I do not have Gilbert's Syndrome or a specific genetic condition.

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I have no health issues that prevent surgery to remove pancreatic cancer.

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My cancer is confirmed as pancreatic adenocarcinoma or adenosquamous carcinoma.

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My tumor can be surgically removed according to my scans.

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I am not pregnant or breastfeeding.

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My disease is confirmed to be removable by surgery according to a specialized imaging review.

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I am not taking strong CYP3A4 inhibitors, or I can stop them before joining.

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I am not taking any strong CYP3A4 inducer medications.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time between randomization and death from any cause, assessed up to 6 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time between randomization and death from any cause, assessed up to 6 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and time between randomization and death from any cause, assessed up to 6 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

Overall survival (OS)

Secondary study objectives

Computed tomography (CT)-based radiomics as non-invasive predictors of overall survival

Disease-free survival (DFS)

Fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (modified [m]FOLFIRINOX) number of cycles received

+12 more

Side effects data

From 2016 Phase 2 trial • 60 Patients • NCT00096226

93%

Fatigue

81%

Dyspnea

72%

Cough

67%

Hemoglobin

65%

Leukopenia NOS

61%

Nausea

60%

Anorexia

60%

Hyperglycemia NOS

58%

Dysphagia

56%

Esophagitis NOS

53%

Dermatitis radiation NOS

49%

Peripheral sensory neuropathy

46%

Weight decreased

44%

Constipation

44%

Alopecia

39%

Neutrophil count

35%

Pneumonitis NOS

33%

Chest pain

32%

Skin hyperpigmentation

30%

Platelet count decreased

30%

Chest wall pain

28%

Hypoalbuminemia

26%

Hyponatremia

25%

Lymphopenia

25%

Diarrhea NOS

25%

Pleural effusion

23%

Dyspepsia

23%

Vomiting NOS

21%

Aspartate aminotransferase increased

21%

Arthralgia

21%

Insomnia

19%

Sinus tachycardia

19%

Pain - Other

19%

Alanine aminotransferase increased

19%

Dehydration

19%

Hypocalcemia

19%

Myalgia

18%

Esophageal pain

18%

Pericardial effusion

18%

Supraventricular arrhythmia NOS

18%

Pyrexia

18%

Hypokalemia

18%

Atelectasis

18%

Pneumothorax NOS

16%

Blood alkaline phosphatase increased

16%

Hyperkalemia

16%

Dysgeusia

14%

Hypomagnesemia

14%

Back pain

14%

Headache

14%

Dizziness

14%

Pharyngolaryngeal pain

14%

Pruritus

12%

Blood/bone marrow - Other

12%

Pulmonary fibrosis

12%

Dry skin

12%

Sweating increased

12%

Hypersensitivity NOS

11%

Radiation recall syndrome

11%

Metabolic/laboratory - Other

11%

Pain in extremity

11%

Depression

11%

Hypoxia

11%

Laryngitis NOS

11%

Dermatitis exfoliative NOS

11%

Hypotension NOS

Dry mouth

Stomatitis

Blood bilirubin increased

Blood creatinine increased

Anxiety

Thrombosis

Pulmonary/upper respiratory - Other

Dermatology/skin - Other

Edema: limb

Hypermagnesemia

Bone pain

Pollakiuria

Bronchospasm

Hot flushes NOS

Rigors

Gastritis NOS

Vision blurred

Mucositis/stomatitis (functional/symptomatic): Esophagus

Blood bicarbonate decreased

Hypercalcemia

Hypophosphatemia

Muscle weakness NOS

Peripheral motor neuropathy

Ataxia

Confusional state

Epistaxis

Rhinitis allergic NOS

Prolonged chest tube drainage or air leak after pulmonary resection

Arrhythmia NOS

Myocardial ischemia

Abdominal distention

Colonic obstruction

Ocular/visual - Other

Ileus paralytic

Serum sickness

Infection with normal ANC or Grade 1 or 2 neutrophils: Wound

Anal infection NOS

Gingival infection

Urinary retention

Acute respiratory distress syndrome

Erythema multiforme

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Chemoradiation, Surgery, Chemotherapy

Awards & Highlights

All Individual Drugs Already Approved

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

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (perioperative chemotherapy, surgery)Experimental Treatment6 Interventions

Patients receive oxaliplatin intravenously (IV) over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-3. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Within 2-8 weeks of completing neoadjuvant chemotherapy, patients undergo surgical resection. Patients then receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-3. Treatment repeats every 14 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (surgery, adjuvant chemotherapy)Active Control6 Interventions

Patients undergo surgical resection. Beginning 3-12 weeks after surgery, patients then receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-3. Treatment repeats every 14 days for 12 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Irinotecan

FDA approved

Oxaliplatin

FDA approved

Fluorouracil

FDA approved

Leucovorin

FDA approved