What side effects are associated with this type of intervention?

Common treatments for gastrointestinal cancer that involve mechanisms similar to Lurbinectedin, such as DNA damage, include chemotherapeutic agents like fluoropyrimidines (e.g., 5-FU), oxaliplatin, and irinotecan. Known side effects of these treatments include gastrointestinal symptoms (nausea, vomiting, diarrhea), hematologic toxicities (neutropenia, anemia), neurotoxicity (peripheral neuropathy), and mucositis. These side effects can vary in severity and may require supportive care or dose adjustments.

What prior FDA approvals exist?

Several FDA-approved drugs for the treatment of gastrointestinal cancers work by causing DNA damage or inhibiting transcription. For instance, oxaliplatin, often used in combination regimens like FOLFOX, induces DNA crosslinking, leading to apoptosis. Another example is irinotecan, which inhibits topoisomerase I, causing DNA damage during replication. These drugs, like Lurbinectedin, target the DNA of cancer cells to inhibit their growth and proliferation.

What other types of research exist?

Promising novel alternatives to Lurbinectedin for gastrointestinal cancer patients include: 1) Riccardin D, which has shown efficacy in reducing cell proliferation, inducing apoptosis, and inhibiting the Wnt signaling pathway in intestinal adenoma formation. 2) Sulindac, which has demonstrated tumorigenesis suppression in genetically defined models of colorectal cancer. 3) Carotenoids and curcumins, such as fucoxanthin, lutein, and THC, which have potential chemopreventive effects against colon carcinogenesis.

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Alkylating agents

Lurbinectedin for Pancreatic Cancer

Phase 2

Recruiting

Led By Erkut Borazanci, MD

Research Sponsored by HonorHealth Research Institute

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed gastrointestinal carcinoma

Eastern Cooperative Oncology Group (ECOG) performance status (PS) score ≤1

Must not have

Neuroendocrine differentiation subtype in histology

Known brain metastases or leptomeningeal disease involvement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up initiation of study treatment up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a medication called lurbinectedin in adults with advanced gastrointestinal cancers. Lurbinectedin works by stopping the cancer cells from growing. The goal is to see how effective and safe this treatment is for these patients.

Who is the study for?

Adults with advanced pancreatic cancer and specific DNA repair mutations who have had up to three prior chemotherapy treatments can join. They must have a measurable tumor, adequate organ function, and an ECOG performance status of ≤1. Pregnant or breastfeeding women, those with more than three chemo treatments, brain metastases, severe heart conditions, or active infections cannot participate.

What is being tested?

The trial is testing the effectiveness and safety of Lurbinectedin (Zepzelca), a drug given through injection for treating advanced pancreatic cancer in patients with certain DNA repair mutations. The goal is to see how well it works on tumors that haven't responded well to previous treatments.

What are the potential side effects?

While not specified here, common side effects of Lurbinectedin may include fatigue, nausea, decreased appetite, diarrhea; blood cell count changes leading to increased risk of infection or bleeding; liver enzyme alterations; and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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My cancer in the digestive system has been confirmed by lab tests.

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I can carry out all my self-care but cannot do heavy physical work.

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I haven't had chemotherapy, investigational drugs, or significant radiotherapy recently.

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My cancer cannot be removed by surgery and has spread.

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I have harmful mutations in specific genes related to DNA repair.

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My blood, liver, and kidney functions are within normal ranges.

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I have recovered from side effects of cancer treatment to mild symptoms.

Exclusion Criteria

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

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My cancer is of the neuroendocrine subtype.

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My cancer has spread to my brain or the lining around my brain.

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I have previously been treated with lurbinectedin or trabectedin.

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I have had more than three chemotherapy treatments for my advanced disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ initiation of study treatment up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~initiation of study treatment up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and initiation of study treatment 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

Evaluate the antitumor activity

Secondary study objectives

Clinical benefit

Duration of response (DOR)

Measure amount of CA19-9, CEA, or CA125

+6 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: LurbinectedinExperimental Treatment1 Intervention

Lurbinectedin will be administered intravenously (IV) as a 1-hour (±10 min) infusion on Day 1 of each cycle (one cycle = 3 weeks ± 48 hours).

0 / 11Eligibility 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

Common treatments for gastrointestinal cancer often target the DNA or cellular pathways to inhibit cancer progression. Lurbinectedin, for example, binds to the minor groove of DNA, causing DNA damage and inhibiting transcription, which leads to cancer cell death. Similarly, other chemotherapeutic agents like fluorouracil (5-FU) and oxaliplatin cause DNA damage or interfere with DNA synthesis, leading to apoptosis of cancer cells. Targeted therapies, such as cetuximab and bevacizumab, inhibit specific pathways like the epidermal growth factor receptor (EGFR) and angiogenesis, respectively, to prevent tumor growth and metastasis. Understanding these mechanisms is crucial for gastrointestinal cancer patients as it helps in selecting the most effective treatment strategy, potentially improving survival rates and reducing side effects.

The effects of intracolonic EGF on mucosal growth and experimental carcinogenesis.The gut microbiome switches mutant p53 from tumour-suppressive to oncogenic.Deciphering the molecular mechanism and apoptosis underlying the in-vitro and in-vivo chemotherapeutic efficacy of vanadium luteolin complex in colon cancer.