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Anti-metabolites

Chemotherapy Combinations for Advanced Pancreatic Cancer

Phase 2

Waitlist Available

Led By Efrat Dotan

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

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

Must have

Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

Male patients must agree not to father children while on study

Must not have

Patients with the following histology are excluded: acinar cell; adenosquamous carcinoma

Patients with a history of hepatitis C virus (HCV) infection who have not been treated and cured, or currently have detectable HCV viral load

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two different combinations of drugs to see which is better at treating metastatic pancreatic cancer in older patients.

Who is the study for?

This trial is for older English-speaking patients with newly diagnosed, untreated metastatic pancreatic cancer. They must have adequate blood counts, organ function, and controlled HIV or hepatitis if present. Men must agree to avoid fathering children during the study. Patients should not be 'frail' as per geriatric assessment and cannot take certain drugs that affect chemotherapy metabolism.

What is being tested?

The trial compares two chemotherapy combinations: gemcitabine hydrochloride with nab-paclitaxel versus fluorouracil with leucovorin calcium and liposomal irinotecan. It aims to determine which combination better prolongs life in older patients with metastatic pancreatic cancer.

What are the potential side effects?

Chemotherapy can cause side effects like nausea, vomiting, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems, fatigue, allergic reactions, liver toxicity (elevated bilirubin), and potential heart complications.

Eligibility Criteria

Inclusion Criteria

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

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I had hepatitis C but am cured, or I'm being treated with no detectable virus.

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I agree not to father a child during the study.

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My hepatitis B virus is under control with treatment.

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I agree not to take any strong CYP3A4 affecting drugs or UGT1A1 inhibitors if assigned to the liposomal irinotecan treatment.

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I am able to care for myself and perform daily activities.

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I have a new, untreated metastatic pancreatic cancer but may have had surgery or therapy before.

Exclusion Criteria

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

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My cancer is not acinar cell or adenosquamous carcinoma.

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I have hepatitis C that is either untreated or still active.

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I am HIV positive and on a treatment that includes ritonavir or cobicistat.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years post treatment 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

Instrumental Activities of Daily Living (IADL)

Other study objectives

Change in functional status

Changes in levels of CRP and IL-6 and toxicity

Comprehensive Geriatric Assessment (CGA) domains

+8 more

Side effects data

From 2022 Phase 3 trial • 87 Patients • NCT02066181

73%

Fatigue

71%

Palmar-plantar erythrodysesthesia syndrome

63%

Hypertension

61%

Papulopustular rash

55%

Diarrhea

51%

Nausea

39%

Myalgia

37%

Alopecia

35%

Arthralgia

33%

Abdominal pain

31%

Anorexia

27%

Vomiting

22%

Mucositis oral

22%

Constipation

18%

Anemia

18%

Alanine aminotransferase increased

16%

Platelet count decreased

14%

Pruritus

14%

Hyperglycemia

14%

Rash maculo-papular

14%

Skin and subcutaneous tissue disorders - Other, specify

12%

Aspartate aminotransferase increased

12%

Rash acneiform

12%

Peripheral sensory neuropathy

10%

Investigations - Other, specify

10%

Dry skin

10%

Neutrophil count decreased

10%

Blood bilirubin increased

Back pain

Headache

Nervous system disorders - Other, specify

Pain in extremity

General disorders and administration site conditions - Other, specify

Skin infection

White blood cell decreased

Hypercalcemia

Hypokalemia

Musculoskeletal and connective tissue disorder - Other, specify

Dizziness

Respiratory, thoracic and mediastinal disorders - Other, specify

Eye disorders - Other, specify

Hyperkalemia

Pain

Alkaline phosphatase increased

Hypocalcemia

Cough

Flushing

Tinnitus

Dental caries

Gastrointestinal disorders - Other, specify

Hemoglobin increased

Weight loss

Metabolism and nutrition disorders - Other, specify

Dysgeusia

Anxiety

Irregular menstruation

Menorrhagia

Sore throat

Lymphocyte count decreased

Hyperuricemia

Non-cardiac chest pain

Infections and infestations - Other, specify

Hypernatremia

Hypoglycemia

Scalp pain

Dry mouth

Hemorrhoids

Blurred vision

Hypothyroidism

Urticaria

Acute kidney injury

Palpitations

Leukocytosis

Myocardial infarction

Vertigo

Anal hemorrhage

Dysphagia

Esophageal pain

Periodontal disease

Fever

Sinusitis

Urinary tract infection

Bruising

Dermatitis radiation

Cholesterol high

Creatinine increased

Neck pain

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Concentration impairment

Memory impairment

Spasticity

Depression

Insomnia

Allergic rhinitis

Productive cough

Sleep apnea

Pregnancy, puerperium and perinatal conditions - Other, specify

Dry eye

Lymphedema

Chest pain - cardiac

Heart failure

Gastric perforation

Hypertriglyceridemia

Dyspnea

Cardiac disorders - Other, specify

Gastroesophageal reflux disease

Oral dysesthesia

Chills

Hypophosphatemia

Chest wall pain

Psychiatric disorders - Other, specify

Hematuria

Urinary tract obstruction

Dysmenorrhea

Skin hypopigmentation

Unintended pregnancy

Flu like symptoms

Nail infection

Pancreatitis

Blood and lymphatic system disorders - Other, specify

Oral pain

Fall

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (Sorafenib Tosylate)

Arm II (Placebo)

Crossover Group

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (fluorouracil, leucovorin, liposomal irinotecan)Experimental Treatment6 Interventions

Patients receive fluorouracil IV over 46 hours starting on day 1. Patients also receive leucovorin IV over 90-120 minutes and liposomal irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm A (gemcitabine, nab-paclitaxel)Experimental Treatment5 Interventions

Patients receive gemcitabine IV over 30 minutes and nab-paclitaxel IV over 30 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fluorouracil

2014

Completed Phase 3

~11700

Gemcitabine

2017

Completed Phase 3

~1920