Status:
COMPLETED
Ph 2 Trial of Vitamin C & G-FLIP (Low Doses Gemcitabine, 5FU, Leucovorin, Irinotecan, Oxaliplatin) for Pancreatic Cancer
Lead Sponsor:
Bruckner Oncology
Collaborating Sponsors:
Hirschfeld Oncology
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Pancreatic cancer, especially at advanced metastatic stage, is a devastating disease. It is the fourth leading cause of cancer death. Its prognosis is grim - 5-year survival rate being 6%. The current...
Detailed Description
STUDY OBJECTIVE The objective of this study is to evaluate the safety, tolerability and efficacy of G-FLIP (Low Doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, and Oxaliplatin), w...
Eligibility Criteria
Inclusion
- Patients must have histologically and cytologically confirmed metastatic (Stage IV), locally advanced unresectable (stage III), or locally recurrent pancreatic adenocarcinoma, with or without prior chemotherapy for their cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status being 0-2.
- Expected survival \>3 months.
- Patients 18 years of age and older of both genders.
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device \[IUD\], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 2 weeks prior to treatment initiation.
- Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists.
- At least 2 weeks must have elapsed from any prior surgery or hormonal therapy.
- Laboratory values ≤2 weeks must be:
- Adequate hematologic
- Adequate hepatic function
- Adequate renal function
- No evidence of active infection and no serious infections within the past month.
- Mentally competent, able to understand and willing to sign the informed consent form.
Exclusion
- Patients under the age of 18.
- Locally advanced resectable disease from pancreatic cancer
- Previous radiotherapy for cerebral metastases, central nervous system (CNS) or epidural tumor.
- Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any non-cancer indication within the past 4 weeks.
- Patients with any active uncontrolled bleeding, or a bleeding diathesis.
- Pregnant women, or women of child-bearing potential not using reliable means of contraception.
- Lactating females.
- Fertile men unwilling to practice contraceptive methods during the study period.
- Life expectancy less than 3 months.
- Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients.
- Unwilling or unable to follow protocol requirements.
- Active heart disease including but not limited to symptomatic congestive heart failure, symptomatic coronary artery disease, symptomatic angina pectoris, symptomatic myocardial infarction, or symptomatic congestive heart failure.
- Patients with a history of myocardial infarction that is \< 3 months prior to registration.
- Patients with any amount of clinically significant pericardial effusion.
- Evidence of active serious infection.
- Patients with known HIV infection.
- Requirement for immediate palliative treatment of any kind including surgery and radiation.
- Patients that have received a chemotherapy regimen requiring stem cell support in the previous 6 months.
- Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient.
Key Trial Info
Start Date :
August 13 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01905150
Start Date
August 13 2014
End Date
January 1 2020
Last Update
December 11 2024
Active Locations (1)
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1
Bruckner Oncology
The Bronx, New York, United States, 10469