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Trial Title:
Clinical Trial Evaluating Low Dose G-FLIP Plus Mitomycin C for Stage IV Pancreatic Cancer
NCT ID:
NCT06233877
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Mitomycins
Mitomycin
Conditions: Keywords:
Pancreatic
low dose
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
G-GLIP plus Mitomycin C
Description:
G-FLIP: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin plus Mitomycin
C
Arm group label:
G-GLIP plus Mitomycin C
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hirscheld Oncology
Address:
City:
Brooklyn
Zip:
11206
Country:
United States
Contact:
Last name:
Karla Witkowski
Phone:
718-732-4050
Email:
karla@honcology.com
Investigator:
Last name:
Azriel Hirschfeld, MD
Email:
Principal Investigator
Start date:
March 15, 2024
Completion date:
January 31, 2028
Lead sponsor:
Agency:
Hirschfeld Oncology
Agency class:
Other
Source:
Hirschfeld Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06233877
