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NCT Number: NCT06233877

Clinical Trial Evaluating Low Dose G-FLIP Plus Mitomycin C for Stage IV Pancreatic Cancer

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hirscheld Oncology

Brooklyn, New York, 11206, United States

Location contact

Azriel Hirschfeld, MD

PRINCIPAL_INVESTIGATOR

Karla Witkowski

CONTACT

[email protected]

718-732-4050

About this study

Objective: Evaluate the safety, tolerability, and efficacy of G-FLIP combined with Mitomycin C for advanced pancreatic cancer.

Design: Open-label study with 60 evaluable subjects. Treatments: G-FLIP administered every 2 weeks, with Mitomycin administered every 4 weeks.

Efficacy Assessments: Based on response criteria (Complete Response, Partial Response, Stable Disease, Progressive Disease), Response Rate, Progression-Free-Survival, Overall Survival, and 12-Month Survival Rate.

Safety Assessments: Include physical exams, symptom evaluation, vital signs, ECOG performance status, clinical pathology, urinalysis, and Quality of Life assessments.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed metastatic (Stage IV) pancreatic adenocarcinoma.
  • Failed first-line chemotherapy.
  • ECOG performance status of 0-2.
  • Expected survival of more than 3 months.
  • Adequate organ function as indicated by lab values.
  • Age 18 or older.
  • Signed informed consent.

Exclusion criteria

  • • Known brain metastases.
  • Significant cardiovascular or other uncontrolled diseases.
  • Pregnant or breastfeeding women

Treatment and study plan

G-GLIP plus Mitomycin C

Drug

G-FLIP: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin plus Mitomycin C

Primary outcomes

  1. Overall Survival

    Time frame: Baseline, 3 months, 6 months, 1 year, and then annually up to 5 years.

    This measure assesses the duration of time from the start of the study until death from any cause.

  2. Response Rate

    Time frame: Baseline, 3 months, 6 months, 1 year, and then annually up to 5 years.

    This measure assesses the rate of disease progression or worsening, as determined by changes in tumor size and appearance on radiological scans. The evaluation is conducted using the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, which provide a standardized method for measuring tumor size and categorizing response to treatment."

Study contacts

Contact information is provided by the study sponsor or research team.

Azriel Hirschfeld, MD

CONTACT

[email protected]

7187324050

Sponsors and collaborators

Lead sponsor

Hirschfeld Oncology

Other Gov

Registry information

Official study title

An Open Label Phase 2 Trial to Evaluate the Safety, Tolerability, and Efficacy of Low Dose G-FLIP in Combination With Mitomycin C in Patients With Stage IV Pancreatic Cancer Who Have Failed First-Line Treatment

Acronym: GFLIPM

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jan 31, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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