Pancreatic Cancer
Conditions
Keywords
Pancreatic, low dose
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.
Interventions
DRUGG-GLIP plus Mitomycin C
G-FLIP: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin plus Mitomycin C
Sponsors
Hirschfeld Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Contacts
Primary ContactAzriel Hirschfeld, MD
Outcome results
None listed