What is the mechanism of action of this treatment?

The most common treatments for pancreatic cancer include chemotherapy and targeted therapies. Chemotherapy agents like FOLFIRINOX (a combination of leucovorin, fluorouracil, oxaliplatin, and irinotecan) and gemcitabine work by interfering with the DNA replication process in cancer cells, thereby inhibiting their growth and inducing cell death. Targeted therapies, such as PARP inhibitors for patients with BRCA mutations, specifically target and inhibit proteins involved in DNA repair mechanisms, making cancer cells more susceptible to damage. These treatments are vital for pancreatic cancer patients as they can help control disease progression, improve survival rates, and provide options when surgery is not feasible.

What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as gemcitabine and nab-paclitaxel, are associated with several side effects. Gemcitabine can cause nausea, vomiting, diarrhea, and hematologic toxicities like neutropenia and thrombocytopenia. Nab-paclitaxel, when combined with gemcitabine, has been shown to increase the incidence of neutropenia, neuropathy, fatigue, and diarrhea. These side effects can vary in severity and may require supportive care to manage symptoms effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including gemcitabine and nab-paclitaxel, which are commonly used in combination for advanced cases. These drugs have shown efficacy in improving survival rates and managing symptoms. Other approved treatments include FOLFIRINOX, a combination of fluorouracil, leucovorin, irinotecan, and oxaliplatin, which is often used for patients with good performance status. Additionally, liposomal irinotecan in combination with fluorouracil and leucovorin has been approved for patients who have progressed on gemcitabine-based therapy. These treatments aim to extend survival and improve the quality of life for patients with advanced pancreatic cancer.

What other types of research exist?

Promising novel alternatives for pancreatic cancer treatment in 2024 include neoadjuvant treatment strategies and the combination of nanoliposomal irinotecan with fluorouracil and folinic acid (nal-IRI plus FF) for second-line treatment in metastatic cases. Ongoing and planned clinical trials are also exploring other novel therapeutics.

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Pancreatic Cancer Screening for Pancreatic Cancer (CAPS5 Trial)

Phase 3

Recruiting

Led By Michael Goggins, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

Hereditary Pancreatitis or Peutz-Jeghers Syndrome or Strong family history of pancreas cancer on one side of the family tree or Confirmed germline mutation carrier (BRCA2, FAMMM, PALB2, BRCA1, HNPCC, PRSS1/2, or CTRC

Be older than 18 years old

Must not have

Stricture or obstruction in the upper GI tract that does not allow passage of the echoendoscope

Medical comorbidities or coagulopathy that contraindicate endoscopy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is overseen by Johns Hopkins clinical research office. Team members at each location will report any major issues to the lead researcher.

Who is the study for?

This trial is for individuals with a scheduled endoscopic evaluation of the pancreas, who either have Hereditary Pancreatitis, Peutz-Jeghers Syndrome, a strong family history of pancreatic cancer, or specific genetic mutations. It's not suitable for those with upper GI tract obstructions, inability to consent, conditions that make endoscopy risky, certain prior surgeries like gastrectomy or if pregnant.

What is being tested?

The CAPS5 Study is testing the effectiveness of secretin and tumor marker gene tests (including CA19-9) alongside MRI in detecting pancreatic cancer in high-risk groups. The study will be monitored by Johns Hopkins' quality assurance group and sub-investigators at each site.

What are the potential side effects?

While this trial focuses on screening methods rather than treatments that typically have side effects like drugs do, procedures involved may include discomfort from endoscopy and potential risks associated with MRIs such as reactions to contrast agents used.

Eligibility Criteria

Inclusion Criteria

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

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I have a genetic condition or a strong family history of pancreatic cancer.

Exclusion Criteria

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

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I have a blockage in my upper digestive tract that prevents certain medical procedures.

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I have health conditions that make endoscopy unsafe for me.

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I've had surgery on my stomach that affects certain medical imaging tests.

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My health severely limits my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 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

Evaluate pancreatic juice for early cancer markers.

Secondary study objectives

Compare pancreas juice with pancreas cyst fluid

Other study objectives

CA-19-9 Antigen

Time disease progression and prevalence

Awards & Highlights

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

9Treatment groups

Active Control

Group I: Group 1 germline mutation carrierActive Control3 Interventions

High Risk Group 3 (Group 1 germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of \~10% or higher): a. \> 50 years old or 10 years younger than the age of the youngest relative affected, if pancreatic cancer is in family, and b. The Patient is a carrier of a confirmed BRCA2, ATM or PALB2 mutation, regardless of family history of pancreatic cancer. b.\> Individual is a carrier of a confirmed FAMMM (p16/CDKN2A) mutation, age 40 years or older, regardless of family history of pancreas cancer.

Group II: Peutz-Jeghers SyndromeActive Control3 Interventions

1. At least 30 years old, and 2. at least 2 of 3 criteria diagnostic of Peutz-Jeghers syndrome (characteristic intestinal hamartomatous polyps, mucocutaneous melanin deposition, or family history of Peutz-Jeghers syndrome), or, 3. known STK11 gene mutation carrier

Group III: Negative controlActive Control1 Intervention

1. are undergoing routine EGD or Colonoscopy; or Endoscopic Ultrasound (EUS) and/or Endoscopic Retrograde Cholangiopancreatography (ERCP) for non-pancreatic indications as part of their standard medical care, and 2. have no clinical or radiologic suspicion of pancreatic disease (chronic pancreatitis or pancreatic cancer)

Group IV: Pancreas cyst, IPMN evaluationActive Control1 Intervention

are undergoing EUS and/or ERCP for evaluation and/or treatment of suspected or proven pancreatic cancer precursor, intraductal papillary mucinous neoplasm (based on clinical presentation and radiologic or prior EUS or radiologic evidence of a dilated main pancreatic duct and/or pancreatic cystic lesion communicating with the pancreatic ductal system).

Group V: Chronic PancreatitisActive Control1 Intervention

1. are undergoing EUS and/or ERCP for evaluation and/or treatment of suspected or proven chronic pancreatitis as part of their standard medical care, and, 2. have no clinical or radiologic suspicion of pancreatic cancer

Group VI: Hereditary pancreatitisActive Control3 Interventions

High risk group 5 (hereditary pancreatitis) with confirmed gene mutations that predispose to chronic pancreatitis, such as PRSS1, PRSS2, CTRC) and age 50 years or older (these patients have an estimated lifetime risk for pancreatic cancer of 40%) or twenty-years since their first attack of pancreatitis, whichever age is younger.

Group VII: Familial pancreas cancer relativesActive Control3 Interventions

High Risk Group 2 (familial pancreatic cancer relatives): 1. \> 55 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and 2. come from a family with 2 or more members with a history of pancreatic cancer (2 of which have a first-degree relationship consistent with familial pancreatic cancer), and 3. have a first-degree relationship with at least one of the relatives with pancreatic cancer. If there are 2 or more affected blood relatives, at least 1 must be a first-degree relative of the individual being screened

Group VIII: Pancreas cancerActive Control1 Intervention

a. are undergoing EUS and/or ERCP for evaluation and/or treatment of suspected or proven pancreatic ductal adenocarcinoma (based on clinical and radiologic evidence)

Group IX: Group 2 germline mutation carrierActive Control3 Interventions

High Risk Group 4 (Group 2 germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of \~5%): 1. \> 50 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and 2. The patient is a carrier of a confirmed BRCA1 or HNPCC (hereditary non-polyposis colorectal cancer or Lynch syndrome, hMLH1, hMSH2, PMS1, hMSH6, EpCAM) gene mutation, and there is \> 1 pancreatic cancer in the family, one of whom is a first- or second-degree relative of the subject to be screened.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for pancreatic cancer include chemotherapy and targeted therapies. Chemotherapy agents like FOLFIRINOX (a combination of leucovorin, fluorouracil, oxaliplatin, and irinotecan) and gemcitabine work by interfering with the DNA replication process in cancer cells, thereby inhibiting their growth and inducing cell death. Targeted therapies, such as PARP inhibitors for patients with BRCA mutations, specifically target and inhibit proteins involved in DNA repair mechanisms, making cancer cells more susceptible to damage. These treatments are vital for pancreatic cancer patients as they can help control disease progression, improve survival rates, and provide options when surgery is not feasible.