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Clinical Trial for Stage IV Pancreatic Cancer with G-FLIP Plus Mitomycin C

This study is for people with advanced (Stage IV) pancreatic cancer that has not responded to initial chemotherapy. Researchers are testing a combination of several anti-cancer drugs, called G-FLIP (Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin), along with another drug called Mitomycin C. The goal is to see if this combination is a safe and effective treatment. To join, you must be at least 18 years old, have metastatic pancreatic cancer, and generally be well enough to participate. The study will measure how long people live (Overall Survival) and how well their cancer responds to the treatment (Response Rate) over several years. The current recruitment status is unclear.

Study design
This is an open-label study, meaning both you and your doctors will know which treatment you are receiving. It plans to include 60 participants.
What's involved
You would receive G-FLIP every two weeks and Mitomycin C every four weeks. You would also have physical exams, symptom evaluations, and blood tests.
Compensation
Not stated in the trial record.
Follow-up
Your overall survival and response to treatment will be measured at baseline, 3 months, 6 months, 1 year, and then annually for up to 5 years.

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NCT06233877

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

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
Hirschfeld Oncology
~60 participants
Updated 2024-02-28 on ClinicalTrials.gov
What's tested:G-GLIP plus Mitomycin C

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival
Measured over Baseline, 3 months, 6 months, 1 year, and then annually up to 5 years.
+1 more outcome measured

Conditions

Pancreatic Cancer

Explore related trials

Pancreatic Carcinoma

Where it's being run

1 sites across 1 states
New York1

Who to contact

Azriel Hirschfeld, MD
[email protected]
7187324050
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Overall SurvivalBaseline, 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 RateBaseline, 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."