What is the mechanism of action of this treatment?

FOLFOX and FOLFIRI are chemotherapy regimens commonly used to treat pancreatic cancer. FOLFOX combines folinic acid (leucovorin), fluorouracil (5-FU), and oxaliplatin. Folinic acid enhances the effectiveness of fluorouracil, which inhibits DNA synthesis in cancer cells, leading to cell death. Oxaliplatin causes DNA crosslinking and damage, further preventing cancer cell replication. FOLFIRI includes folinic acid, fluorouracil, and irinotecan. Irinotecan inhibits topoisomerase I, an enzyme crucial for DNA replication, causing DNA damage and cell death. These mechanisms are vital for pancreatic cancer patients as they target rapidly dividing cancer cells, aiming to reduce tumor size and slow disease progression, thereby potentially improving survival and quality of life.

What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as FOLFOX and FOLFIRI, have several known side effects. FOLFOX, which includes folinic acid, fluorouracil, and oxaliplatin, can cause neuropathy, neutropenia, nausea, vomiting, diarrhea, and fatigue. FOLFIRI, which includes folinic acid, fluorouracil, and irinotecan, is associated with side effects like diarrhea, neutropenia, nausea, vomiting, and fatigue. Both regimens can also lead to mucositis and increased risk of infection due to immunosuppression.

What prior FDA approvals exist?

The FDA has approved several chemotherapy regimens for the treatment of pancreatic cancer. Notably, FOLFIRINOX, which includes folinic acid, fluorouracil, oxaliplatin, and irinotecan, has been approved and shown to improve survival over gemcitabine alone in metastatic pancreatic cancer. Additionally, gemcitabine combined with nanoparticle albumin-bound paclitaxel (nab-paclitaxel) has also been approved for advanced pancreatic cancer, demonstrating a clear survival benefit. These regimens are similar to FOLFOX (folinic acid, fluorouracil, and oxaliplatin) and FOLFIRI (folinic acid, fluorouracil, and irinotecan), which are used in other gastrointestinal cancers and are being studied for their efficacy in pancreatic cancer.

What other types of research exist?

Promising novel alternatives to FOLFOX and FOLFIRI for pancreatic cancer patients include: 1) Gemcitabine plus nanoparticle albumin-bound paclitaxel (nab-paclitaxel), which has shown a clear survival benefit over single-agent gemcitabine. 2) Liposomal irinotecan in combination with fluorouracil (FU) and leucovorin (LV), which has been approved for patients with metastatic pancreatic cancer following prior gemcitabine-based treatment. 3) Oxaliplatin-based regimens combined with capecitabine or S-1, which have demonstrated activity in patients who have failed single-agent gemcitabine.

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Anti-metabolites

Chemotherapy for Pancreatic Cancer

Phase 2

Recruiting

Research Sponsored by Fox Chase Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients must have bone marrow and organ function within specified ranges.

Age 65 years or older

Must not have

Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active bacterial infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Patients with chronic diarrhea unresolved despite best supportive care for greater than 2 weeks.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests alternating chemotherapy treatments for patients over 65 with newly diagnosed metastatic pancreatic cancer. The goal is to see how well these treatments are tolerated and how effective they are. The drugs work by attacking and killing cancer cells to slow down or stop the cancer from spreading.

Who is the study for?

This trial is for people over 65 with a specific type of untreated pancreatic cancer that has spread. They must have finished any previous radiation at least 2 weeks before and any adjuvant therapy over 6 months prior to consent. Participants need good organ function, understand English, be able to complete assessments, and use effective contraception if applicable.

What is being tested?

The study tests the effectiveness of alternating FOLFOX and FOLFIRI chemotherapy regimens in older patients with metastatic pancreatic cancer. It aims to evaluate how well they tolerate this treatment combination and what toxic effects may occur.

What are the potential side effects?

Possible side effects include reactions related to chemotherapy such as nausea, vomiting, diarrhea, fatigue, decreased blood cell counts leading to increased infection risk or bleeding problems, nerve damage causing numbness or tingling sensations.

Eligibility Criteria

Inclusion Criteria

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

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My blood tests show my organs and bone marrow are working well.

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I am 65 years old or older.

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I am able to get out of my bed or chair and move around.

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I have a new, untreated pancreatic cancer that has spread, with measurable tumors.

Exclusion Criteria

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

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I do not have any severe illnesses that could interfere with the study.

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I have had chronic diarrhea for more than 2 weeks despite treatment.

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My cancer is a type of pancreatic cancer.

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I have brain metastases, whether treated or not.

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I haven't had chemotherapy for cancer that has spread or cannot be removed by surgery.

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I have not had radiation therapy in the last 2 weeks.

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I have severe nerve damage in my hands or feet.

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I have had cancer signs within the last 2 years without complete treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

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

To assess the toxicity profile of a regimen of alternating FOLFOX and FOLFIRI patients assessed as per NCI's CTCAE v5.0 criteria.

Secondary study objectives

To assess the Delayed Toxicity Rate

To assess the Objective Response Rate (ORR)

To assess the Overall Survival (OS)

+1 more

Side effects data

From 2023 Phase 2 trial • 19 Patients • NCT01595321

100%

Lymphocyte count decreased

100%

Febrile neutropenia

100%

Chills

100%

Diarrhea

100%

Fatigue

100%

Bone pain

67%

Abdominal pain

67%

Alopecia

67%

Neutrophil count decreased

67%

Hypomagnesemia

67%

Epistaxis

67%

Nausea

67%

Flatulence

67%

White blood

67%

Hypokalemia

67%

Weight loss

67%

Anorexia

67%

Vomiting

67%

Platelet count decreased

67%

Dry Skin

67%

Anemia

33%

Dehydration

33%

Agitation

33%

Insomnia

33%

Small intestinal obstruction, partial

33%

Skin tears

33%

Atelectasis

33%

Fall

33%

Headache

33%

Pleural effusion

33%

Hypophosphatemia

33%

Hepatic infection

33%

Pain

33%

Bruising

33%

Concentration impairment

33%

Fecal incontinence

33%

Mucositis (oral ulcers)

33%

Wound dehiscence

33%

Peripheral sensory neuropathy

33%

Somnolence

33%

Lip infection

33%

Decreased breath sounds

33%

Hoarseness

33%

Hearing imaired

33%

Dysgeusia

33%

Gastroesophageal reflux disease

33%

Hypocalcemia

33%

Sepsis

33%

Sinus tachycardia

33%

Syncope

33%

Sore throat

33%

Ascities

33%

Dizziness

33%

Gastrointestinal pain

33%

Hypoalbuminemia

33%

Peripheral motor neuropathy

33%

Fever

33%

Skin and Subcutaneous Tissue disorder

33%

Lower gastrointestinal hemorrhage

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1: SBRT and FOLFIRINOX

Cohort 2: SBRT and Modified FOLFIRINOX

Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX

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: Experimental: FOLFIRINOXExperimental Treatment1 Intervention

FOLFIRINOX: Oxaliplatin, Leucovorin and 5-Fluorouracl, Irinotecan,

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

FOLFIRINOX

2013

Completed Phase 3

~800

0 / 12Eligibility 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

FOLFOX and FOLFIRI are chemotherapy regimens commonly used to treat pancreatic cancer. FOLFOX combines folinic acid (leucovorin), fluorouracil (5-FU), and oxaliplatin. Folinic acid enhances the effectiveness of fluorouracil, which inhibits DNA synthesis in cancer cells, leading to cell death. Oxaliplatin causes DNA crosslinking and damage, further preventing cancer cell replication. FOLFIRI includes folinic acid, fluorouracil, and irinotecan. Irinotecan inhibits topoisomerase I, an enzyme crucial for DNA replication, causing DNA damage and cell death. These mechanisms are vital for pancreatic cancer patients as they target rapidly dividing cancer cells, aiming to reduce tumor size and slow disease progression, thereby potentially improving survival and quality of life.