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

60 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug G-FLIP plus Mitomycin C for pancreatic cancer?

Research shows that the G-FLIP regimen, which includes gemcitabine, 5-fluorouracil, leucovorin, and cisplatin, has been effective in treating metastatic pancreatic cancer, with a median overall survival of 8.1 months and a disease control rate of 55%. Additionally, mitomycin C has been used in combination with other drugs for pancreatic cancer, suggesting potential benefits when combined with G-FLIP. ^{1 2 3 4 5}

Is the G-FLIP + Mitomycin C treatment generally safe for humans?

The G-FLIP regimen, which includes gemcitabine, 5-fluorouracil, leucovorin, and cisplatin, has been found to be generally well tolerated in patients with metastatic pancreatic cancer, with some experiencing mild to moderate side effects like nausea, fatigue, and diarrhea. Mitomycin C, when used in isolated perfusion for pancreatic cancer, showed very mild short- and long-term toxicities in a canine model, suggesting it may be safe for clinical use. ^{1 2 3 6 7}

What makes the drug G-FLIP + Mitomycin C unique for treating pancreatic cancer?

The G-FLIP regimen combines four drugs (gemcitabine, 5-fluorouracil, leucovorin, and cisplatin) to maximize their combined effect while minimizing side effects, and adding Mitomycin C may enhance its effectiveness. This combination is designed to improve outcomes for patients with metastatic pancreatic cancer, offering a potentially more effective option than single-agent therapies. ^{1 2 3 5 7}

What is the purpose of this trial?

The study focuses on advanced metastatic pancreatic cancer, testing a combination of low-dose anti-cancer drugs (G-FLIP: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin) with the addition of Mitomycin C. The aim is to find a safer and more effective therapy for this devastating disease.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Irinotecan combined with gemcitabine, 5-fluorouracil, leucovorin, and cisplatin (G-FLIP) is an effective and noncrossresistant treatment for chemotherapy refractory metastatic pancreatic cancer. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Pooled efficacy analysis from a phase I-II study of biweekly irinotecan in combination with gemcitabine, 5-fluorouracil, leucovorin and cisplatin in patients with metastatic pancreatic cancer. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Long-term analysis of 2 prospective studies that incorporate mitomycin C into an adjuvant chemoradiation regimen for pancreatic and periampullary cancers. [2022]

4. Romania pubmed.ncbi.nlm.nih.gov

Prospective study on warfarin and regional chemotherapy in patients with pancreatic carcinoma. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of gemcitabine plus cisplatin versus gemcitabine alone in the treatment of metastatic pancreatic cancer. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Isolated perfusion of pancreas with mitomycin C. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Phase II study of profiromycin vs mitomycin-C utilizing acute intermittent schedules. [2019]