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 often leads to myelosuppression, resulting in neutropenia, anemia, and thrombocytopenia, along with flu-like symptoms, elevated liver enzymes, and gastrointestinal issues like nausea and vomiting. Nab-paclitaxel frequently causes neuropathy, myelosuppression, and gastrointestinal symptoms. When these agents are combined, the risk of these side effects can increase, requiring careful monitoring and potential dose adjustments.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer that inhibit DNA synthesis and cell division. Gemcitabine, a nucleoside analog, was approved in 1996 and works by inhibiting DNA synthesis. Nab-paclitaxel, an albumin-bound formulation of paclitaxel, was approved in 2013 for use in combination with gemcitabine. This combination has shown improved survival rates in patients with metastatic pancreatic cancer. These drugs are similar to the ones being studied in the trial involving Lonsurf, gemcitabine, and nab-paclitaxel, as they all target the disruption of cancer cell replication and division.

What other types of research exist?

Promising novel alternatives for pancreatic cancer treatment include: 1) Platinum-based regimens such as gemcitabine plus cisplatin or FOLFIRINOX, especially for patients with BRCA or PALB2 mutations. 2) Maintenance therapy with PARP inhibitors like olaparib after initial platinum-based chemotherapy for patients with germline BRCA or PALB2 mutations. These alternatives have shown significant efficacy and are recommended by updated consensus-based guidelines.

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Anti-metabolites

Lonsurf + Chemotherapy for Pancreatic Cancer

Phase 1

Waitlist Available

Led By Patrick J Loehrer, MD

Research Sponsored by Patrick Joseph Loehrer Sr.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment until treatment discontinuation (i.e. up to 2 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of three drugs to treat pancreatic cancer. It aims to find the best dose and see how safe and effective the treatment is for patients with this type of cancer. Gemcitabine has been a mainstay treatment for metastatic pancreatic cancer, often used in combination therapies to improve outcomes.

Who is the study for?

This trial is for adults with confirmed pancreatic ductal adenocarcinoma (PDAC) who have adequate organ function and can consent to treatment. Women must not be pregnant and participants must agree to use contraception. Exclusions include recent major surgery, bowel obstruction, uncontrolled illnesses or infections, certain heart conditions, known hypersensitivity to study drugs, neuropathy greater than Grade 1, untreated brain metastases, or prior chemotherapy for other cancers within the last three years.

What is being tested?

The trial is testing the combination of Lonsurf with Gemcitabine and Nab-Paclitaxel in patients with advanced PDAC. The goal is to determine the safest and most effective dose level for this drug combination.

What are the potential side effects?

Potential side effects may include nausea, vomiting, diarrhea (all expected to be mild), blood disorders like low hemoglobin levels or platelet counts, liver enzyme elevations indicating potential liver damage. There's also a risk of allergic reactions due to sensitivity towards gemcitabine or taxanes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment until treatment discontinuation (i.e. up to 2 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment until treatment discontinuation (i.e. up to 2 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment until treatment discontinuation (i.e. up to 2 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

Frequency of Dose Limiting Toxicities (DLTs)

Secondary study objectives

Disease control rate (DCR)

European Organization for Research and Treatment of Cancer quality of life questionnaire

Frequency of adverse events in the safety evaluable population

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Combination of lonsurf + gemcitabine + nab-paclitaxelExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nab-Paclitaxel

2014

Completed Phase 3

~4540

Gemcitabine

2017

Completed Phase 3

~1920

Do I qualify?Apply below to find out

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

Common treatments for pancreatic cancer, such as Lonsurf, Gemcitabine, and Nab-paclitaxel, work by inhibiting DNA synthesis and cell division. Lonsurf combines trifluridine, which incorporates into DNA and inhibits its function, with tipiracil, which prevents trifluridine degradation. Gemcitabine is a nucleoside analog that interferes with DNA replication, while Nab-paclitaxel stabilizes microtubules, preventing cell division. These mechanisms are crucial as they target the rapid proliferation of cancer cells, offering a strategic approach to slow down or stop tumor growth, which is vital for managing pancreatic cancer.