G-FLIP + Mitomycin C for Pancreatic Cancer

(GFLIPM Trial)

Overseen By Azriel Hirschfeld, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hirschfeld Oncology

Disqualifiers: Brain metastases, Cardiovascular diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of cancer drugs for advanced pancreatic cancer that has spread. Researchers are combining several low-dose anti-cancer drugs (called G-FLIP) with Mitomycin C to determine if this mix is safer and more effective than current treatments. The trial seeks participants whose pancreatic cancer has not responded to initial chemotherapy. Participants should also maintain a good level of daily functioning and have an expected survival of more than three months. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that the combination of G-FLIP and Mitomycin C is being tested for safety in treating advanced pancreatic cancer. Previous studies indicate that G-FLIP, which uses low doses of several cancer-fighting drugs, is usually well-tolerated by patients. These drugs are given at about half the usual dose, helping to reduce side effects.

Earlier trials reported that adding Mitomycin C to G-FLIP remains manageable for patients. Some side effects have been observed, but they generally align with typical cancer treatments. While discomfort can occur, serious problems are less common.

Overall, this combination aims to offer a safer treatment option by using lower doses. However, anyone considering this treatment should discuss potential side effects with their doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pancreatic cancer?

Researchers are excited about the combination of G-FLIP and Mitomycin C for pancreatic cancer because it offers a novel strategy by combining several chemotherapy agents that target cancer cells in different ways. While standard treatments like FOLFIRINOX or gemcitabine with nab-paclitaxel focus on disrupting cancer cell DNA or cell division, G-FLIP includes a broader mix of drugs: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin, each with unique mechanisms that together may enhance their effectiveness. Adding Mitomycin C, which can crosslink DNA strands, further distinguishes this treatment by potentially increasing cancer cell death. This multifaceted approach could lead to improved outcomes for patients with pancreatic cancer.

What evidence suggests that G-FLIP plus Mitomycin C might be an effective treatment for pancreatic cancer?

Research has shown that combining G-FLIP with Mitomycin C, which participants in this trial will receive, may help treat advanced pancreatic cancer that has spread. Studies have found that G-FLIP, using low doses of four drugs—gemcitabine, fluorouracil, leucovorin, and irinotecan—can work against pancreatic cancer. Adding Mitomycin C, another cancer-fighting drug, might enhance this treatment. Early results suggest this combination could be safer and more effective than higher doses. This method aims to use lower doses to reduce side effects while still targeting cancer cells. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced pancreatic cancer that has spread, who have already tried one chemotherapy but need a new option. They should be expected to live more than 3 months and be able to do some daily activities on their own.

Inclusion Criteria

My cancer is a type of pancreatic cancer that has spread.

Expected survival of more than 3 months.

My first cancer treatment did not work.

Exclusion Criteria

I have cancer that has spread to my brain.

I do not have severe heart disease or other uncontrolled conditions.

Pregnant or breastfeeding women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive G-FLIP every 2 weeks and Mitomycin C every 4 weeks

6 months

Bi-weekly visits for G-FLIP, monthly visits for Mitomycin C

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Annual visits

What Are the Treatments Tested in This Trial?

Interventions

• G-FLIP plus Mitomycin C

Trial Overview The study tests a low-dose mix of anti-cancer drugs (G-FLIP: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, Oxaliplatin) plus Mitomycin C in patients with stage IV pancreatic cancer to find a treatment that's both safer and more effective.

How Is the Trial Designed?

Group I: G-GLIP plus Mitomycin C Experimental Treatment 1 Intervention

G-FLIP: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin every 2 weeks plus Mitomycin C every 4 weeks

Who Is Running the Clinical Trial?

Hirschfeld Oncology

Lead Sponsor

Trials

2

Recruited

90+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01905150

Ph 2 Trial of Vitamin C & G-FLIP (Low Doses Gemcitabine ... The objective of this study is to evaluate the safety, tolerability and efficacy of G-FLIP (Low Doses of Gemcitabine, Fluorouracil [5FU], Leucovorin, Irinotecan ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06233877

Clinical Trial Evaluating Low Dose G-FLIP Plus Mitomycin ... The study focuses on advanced metastatic pancreatic cancer, testing a combination of low-dose anti-cancer drugs (G-FLIP: Gemcitabine, Fluorouracil, Leucovorin, ...

3. asco.org asco.org/abstracts-presentations/ABSTRACT170882

An open-label phase II trial of G-FLIP (low doses ... Background: G-FLIP is a low dose combination chemotherapeutic regimen which utilizes drugs at approximately 1/2 of the standard doses.

4. withpower.com withpower.com/trial/phase-2-pancreatic-neoplasms-1-2024-62290

G-FLIP + Mitomycin C for Pancreatic Cancer (GFLIPM Trial) Research shows that the G-FLIP regimen, which includes gemcitabine, 5-fluorouracil, leucovorin, and cisplatin, has been effective in treating metastatic ...

5. asco.org asco.org/abstracts-presentations/ABSTRACT84609

Adding docetaxel and mitomycin-C to low-dose multi-drug ... Conclusions: Adding TXT and MMC to GFLIP/Ox is a feasible second line option for patients with refractory pancreatic cancer. These data further support the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3435778/

FOLFIRI regimen in metastatic pancreatic adenocarcinoma ... We have evaluated the efficacy and safety of the FOLFIRI regimen after the failure of both gemcitabine and platinum salts in 63 patients with metastatic PAC ...