Ph 2 Trial of Vitamin C & G-FLIP (Low Doses Gemcitabine, 5FU, Leucovorin, Irinotecan, Oxaliplatin) for Pancreatic Cancer

Launched by BRUCKNER ONCOLOGY · Jul 22, 2013

Keywords

ClinConnect Summary

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), when used in combination with ascorbic acid (Vitamin C), as first-line therapy in patients with advanced pancreatic cancer. The objective of this study is also to evaluate the safety, tolerability and efficacy of G-FLIP-DM (G-FLIP + Low Doses of Docetaxel and Mitomycin C), when used in combination with ascorbic acid, in patients with advanced pancreatic cancer who develop Disease Progression (DP...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.