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

Phase 2

Not yet recruiting

• Conditions: Pancreatic Cancer
• Interventions: Drug: G-GLIP plus Mitomycin C

• Registration Number: NCT06233877
• Lead Sponsor: Hirschfeld Oncology

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Study Start: 2024-03-15
• Primary Completion: 2027-01-31
• Study Completion: 2028-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Response Rate	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."
Overall Survival	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.

Trial Locations

Locations (1)

Hirscheld Oncology; 🇺🇸 Brooklyn, New York, United States