What is the mechanism of action of this treatment?

Common treatments for pancreatic cancer include chemotherapy agents like FOLFIRINOX (a combination of fluorouracil, leucovorin, irinotecan, and oxaliplatin) and gemcitabine-based regimens. These treatments work by interfering with DNA replication and repair mechanisms, which is crucial for rapidly dividing cancer cells. For instance, glufosfamide, an alkylating agent, disrupts DNA replication and transcription, leading to cell death. This is particularly important for pancreatic cancer patients as these mechanisms target the cancer cells' ability to proliferate, potentially slowing disease progression and improving survival outcomes.

What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as alkylating agents like glufosfamide, often cause side effects including myelosuppression, gastrointestinal disturbances, and nephrotoxicity. Other treatments like 5-fluorouracil (5-FU) can lead to mucositis, hand-foot syndrome, and cardiotoxicity, while gemcitabine is associated with flu-like symptoms, fatigue, and hematologic toxicities such as neutropenia and thrombocytopenia.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, focusing on improving survival and quality of life. Gemcitabine was one of the first drugs approved for first-line therapy due to its significant improvements in clinical benefit and survival. Combination therapies such as FOLFIRINOX (a regimen including fluorouracil, leucovorin, irinotecan, and oxaliplatin) and gemcitabine plus nab-paclitaxel have shown clear survival benefits over single-agent gemcitabine. These regimens are often used in patients with good performance status. For patients with specific genetic mutations, such as BRCA or PALB2, the PARP inhibitor olaparib is an option following platinum-based chemotherapy. While glufosfamide, an alkylating agent, is being studied, it is not yet FDA-approved for pancreatic cancer.

What other types of research exist?

Promising novel alternatives to Glufosfamide for pancreatic cancer patients include investigational agents such as regorafenib, cabozantinib, sorafenib, and lenvatinib. These agents have shown some limited activity in cancer treatment and may offer new therapeutic options for pancreatic cancer patients.

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Anti-metabolites

Glufosfamide vs Fluorouracil for Pancreatic Cancer

Phase 3

Recruiting

Research Sponsored by Eleison Pharmaceuticals LLC.

Eligibility Criteria Checklist

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

Must have

All women of childbearing potential and all men must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose of chemotherapy

Pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided)

Must not have

Major surgery within 3 weeks of the start of study treatment, without complete recovery

Active clinically significant infection requiring antibiotics

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 3-6 months

Awards & highlights

Approved for 5 Other Conditions

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing if the chemotherapy drug glufosfamide can help people with advanced pancreatic cancer live longer. These patients have already tried another treatment called gemcitabine, which didn't work for them. Glufosfamide aims to stop cancer cells from growing by damaging their DNA.

Who is the study for?

This trial is for adults with metastatic pancreatic cancer who have not responded to gemcitabine-based treatment. They must be in good physical condition, able to consent, and agree to use contraception. Exclusions include symptomatic brain metastases, active infections or other cancers, recent major surgery without recovery, significant lab abnormalities, pregnancy or breastfeeding, insulin-dependent diabetes, and certain heart conditions.

What is being tested?

The study compares the effectiveness of glufosfamide versus fluorouracil (5-FU) in improving survival for patients with advanced pancreatic cancer after first-line therapy failure. Participants will receive either glufosfamide or bolus 5-FU as a second-line treatment option.

What are the potential side effects?

Potential side effects may include reactions at the infusion site, nausea and vomiting from chemotherapy drugs like fluorouracil (5-FU), low blood counts leading to increased infection risk or bleeding tendencies, liver enzyme alterations suggesting liver stress or damage.

Eligibility Criteria

Inclusion Criteria

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

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I agree to use effective contraception during and for 6 months after the study.

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My pancreatic cancer was confirmed through a biopsy.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My cancer has spread from the pancreas to other parts of my body.

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My condition worsened despite treatment with gemcitabine.

Exclusion Criteria

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

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I had major surgery less than 3 weeks ago and haven't fully recovered.

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I am currently taking antibiotics for a serious infection.

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I cannot or do not want to have multiple CT scans.

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I have had more than one treatment for my metastatic pancreatic cancer.

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I have brain metastases but do not show symptoms.

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I am HIV positive or have active hepatitis B or C.

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My kidney function, measured by creatinine clearance, is below 60 mL/min.

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I am not pregnant or breastfeeding.

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I have had serious heart problems or symptoms in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 3-6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 3-6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3-6 months 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

Side effects data

From 2008 Phase 2 trial • 22 Patients • NCT00441467

50%

Nausea

50%

Vomiting

23%

Fatigue

23%

Renal failure

23%

Alopecia

18%

Neutropenia

18%

Anorexia

14%

Fatigue aggravated

14%

Anemia aggravated

14%

Insomnia

14%

Nausea aggravated

Weakness

Pain aggravated

Shoulder pain

Dehydration

Anemia

Thrombocytopenia

Hypokalemia

Hypophosphatemia

Depression aggravated

Dizziness

Headache

Cough

Dyspnea

Dyspnea exacerbated

Sore throat

Abdominal bloating

Abdominal pain

Constipation

Constipation agravated

Diarrhea

Mucositis oral

Back pain aggravated

General body pain

Intractable nausea and vomiting

Sarcoma site hemorrhage

100%

80%

60%

40%

20%

Study treatment Arm

Glufosfamide

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: glufosfamideExperimental Treatment1 Intervention

Glufosfamide: 4500 mg/m2 IV over 6 hours on Day 1 of each 21-day cycle

Group II: 5-FUActive Control1 Intervention

Fluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Glufosfamide

Not yet FDA approved

0 / 15Eligibility 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 pancreatic cancer include chemotherapy agents like FOLFIRINOX (a combination of fluorouracil, leucovorin, irinotecan, and oxaliplatin) and gemcitabine-based regimens. These treatments work by interfering with DNA replication and repair mechanisms, which is crucial for rapidly dividing cancer cells. For instance, glufosfamide, an alkylating agent, disrupts DNA replication and transcription, leading to cell death. This is particularly important for pancreatic cancer patients as these mechanisms target the cancer cells' ability to proliferate, potentially slowing disease progression and improving survival outcomes.

Phospho-Aspirin (MDC-22) Prevents Pancreatic Carcinogenesis in Mice.