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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
Creatinine =< institutional ULN unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2 (obtained within 4 weeks of registration)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years post treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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My kidney function is within the safe range for the study.
Select...
I agree not to father a child during the study.
Select...
My hepatitis B virus is under control with treatment.
Select...
My disease can be measured and I've had scans within the last 4 weeks.
Select...
My kidney function is within the safe range for the trial.
Select...
I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.
Select...
I agree not to take any strong CYP3A4 affecting drugs or UGT1A1 inhibitors if assigned to the liposomal irinotecan treatment.
Select...
I am able to care for myself and perform daily activities.
Select...
I have a new, untreated metastatic pancreatic cancer but may have had surgery or therapy before.
Select...
My heart is healthy enough for treatment, even with my history of heart issues or treatments.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Instrumental Activities of Daily Living (IADL)
Other outcome measures
Change in functional status
Changes in levels of CRP and IL-6 and toxicity
Co-morbidities as a predictor of chemotherapy tolerance
+14 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
8%
Back pain
8%
Headache
8%
Nervous system disorders - Other, specify
8%
Pain in extremity
6%
General disorders and administration site conditions - Other, specify
6%
Skin infection
6%
White blood cell decreased
6%
Hypercalcemia
6%
Hypokalemia
6%
Musculoskeletal and connective tissue disorder - Other, specify
6%
Dizziness
6%
Respiratory, thoracic and mediastinal disorders - Other, specify
6%
Eye disorders - Other, specify
6%
Hyperkalemia
6%
Pain
6%
Alkaline phosphatase increased
6%
Hypocalcemia
6%
Cough
4%
Flushing
4%
Tinnitus
4%
Dental caries
4%
Gastrointestinal disorders - Other, specify
4%
Hemoglobin increased
4%
Weight loss
4%
Metabolism and nutrition disorders - Other, specify
4%
Dysgeusia
4%
Anxiety
4%
Irregular menstruation
4%
Menorrhagia
4%
Sore throat
4%
Lymphocyte count decreased
4%
Hyperuricemia
4%
Non-cardiac chest pain
4%
Infections and infestations - Other, specify
4%
Hypernatremia
4%
Hypoglycemia
4%
Scalp pain
4%
Dry mouth
2%
Hypothyroidism
2%
Hemorrhoids
2%
Blurred vision
2%
Palpitations
2%
Acute kidney injury
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Anal hemorrhage
2%
Dysphagia
2%
Esophageal pain
2%
Periodontal disease
2%
Fever
2%
Sinusitis
2%
Urinary tract infection
2%
Bruising
2%
Dermatitis radiation
2%
Cholesterol high
2%
Creatinine increased
2%
Neck pain
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Concentration impairment
2%
Memory impairment
2%
Spasticity
2%
Depression
2%
Insomnia
2%
Allergic rhinitis
2%
Productive cough
2%
Sleep apnea
2%
Pregnancy, puerperium and perinatal conditions - Other, specify
2%
Dry eye
2%
Lymphedema
2%
Chest pain - cardiac
2%
Heart failure
2%
Gastric perforation
2%
Hypertriglyceridemia
2%
Dyspnea
2%
Cardiac disorders - Other, specify
2%
Gastroesophageal reflux disease
2%
Oral dysesthesia
2%
Chills
2%
Hypophosphatemia
2%
Chest wall pain
2%
Psychiatric disorders - Other, specify
2%
Hematuria
2%
Urinary tract obstruction
2%
Dysmenorrhea
2%
Skin hypopigmentation
2%
Urticaria
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Sorafenib Tosylate)
Arm II (Placebo)
Crossover Group

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
~11540
Gemcitabine
2017
Completed Phase 3
~2070
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Leucovorin
2005
Completed Phase 4
~5730
Leucovorin Calcium
2011
Completed Phase 3
~12290
Liposomal Irinotecan
2019
Completed Phase 1
~20
Nab-paclitaxel
2014
Completed Phase 3
~2030

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
115 Previous Clinical Trials
176,646 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,470 Total Patients Enrolled
Efrat DotanPrincipal InvestigatorECOG-ACRIN Cancer Research Group
2 Previous Clinical Trials
8 Total Patients Enrolled

Media Library

Fluorouracil (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04233866 — Phase 2
Pancreatic Cancer Research Study Groups: Arm A (gemcitabine, nab-paclitaxel), Arm B (fluorouracil, leucovorin, liposomal irinotecan)
Pancreatic Cancer Clinical Trial 2023: Fluorouracil Highlights & Side Effects. Trial Name: NCT04233866 — Phase 2
Fluorouracil (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04233866 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment size for this research endeavor?

"Affirmative. According to clinicaltrials.gov, this medical trial is actively seeking participants and has been since June 18th 2020; the study's details were most recently updated on June 8th 2022. 184 people across 43 sites must be enrolled in order for it to be successful."

Answered by AI

How is Quality-of-Life Assessment typically utilized?

"Quality-of-Life Assessment is a viable therapeutic option for mesotheliomas, as well as other afflictions such as osteomalacia, hemodialysis and advanced soft tissue sarcoma."

Answered by AI

What other trials have examined the Quality-of-Life Assessment of participants?

"Quality-of-Life Assessment has been studied since 1997 at the City of Hope Comprehensive Cancer Center, with 3216 completed clinical trials to date. Presently, 1560 active studies are being conducted in several locations across America - many out of Lancaster, Idaho."

Answered by AI

How many geographical areas are the research participants located in?

"This clinical trial is enrolling patients in various hospitals, such as Fairfield Medical Center, Walter Knox Memorial Hospital and Kalispell Regional Medical Center. Additionally, there are 43 additional sites recruiting subjects for this study."

Answered by AI

What risks can be associated with Quality-of-Life Evaluation?

"The safety of Quality-of-Life Assessment was assessed by our team at Power as a 2, due to the lack of clinical data demonstrating efficacy but with some evidence supporting its security."

Answered by AI

Is there still a possibility to join this medical research experiment?

"Affirmative. The information on clinicaltrials.gov indicates this clinical trial is still recruiting participants, which was initially posted on June 18th 2020 and last amended on June 8th 2022. 184 patients need to be recruited from 43 distinct sites."

Answered by AI

Who else is applying?

What site did they apply to?
Genesis Healthcare System Cancer Care Center
Phelps Memorial Hospital Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
~58 spots leftby Dec 2025