Trial record 11 of 101 for:    Open Studies | "Ascorbic Acid"

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

This study is not yet open for participant recruitment.
Verified July 2013 by Bruckner Oncology
Sponsor:
Information provided by (Responsible Party):
Bruckner Oncology
ClinicalTrials.gov Identifier:
NCT01905150
First received: July 18, 2013
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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 therapies for advanced metastatic pancreatic cancer are very toxic and with limited efficacy. A safer and more effective therapy for this devastating disease is greatly needed.

G-FLIP regimen is a combination of low doses (doses lower than those approved by the FDA and used in the clinic) of several anti-cancer drugs, Gemcitabine, Fluorouracil, Leucovorin, Irinotecan and Oxaliplatin. The efficacy of G-FLIP against cancers (especially pancreatic cancer) is based on laboratory and clinical results, which indicates the synergistic efficacy of these anti-cancer drugs against cancer cells and overcoming tumor drug resistance that cancer cells frequently develop. Also, because of their low doses, this regimen is less toxic than when these drugs are used alone.

Meanwhile, intravenous infusion of high doses (doses significantly higher than the daily nutritional requirements) of Vitamin C (ascorbic acid) has been observed to have anti-cancer activities. This is especially true when Vitamin C is used in combination with other anti-cancer drugs.


Condition Intervention Phase
Stage IV Pancreatic Cancer
Drug: G-FLIP
Drug: G-FLIP-DM
Dietary Supplement: Vitamin C
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ph 2 Trial of G-FLIP (Low Doses Gemcitabine, 5FU, Leucovorin, Irinotecan & Oxaliplatin), Followed by G-FLIP-DM (G-FLIP + Low Doses Docetaxel & Mitomycin C), When Used in Combination With Vitamin C in Patients With Stage IV Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Bruckner Oncology:

Primary Outcome Measures:
  • 12-month survival rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The number of subjects that survive 12 months after the start of treatment


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The number of study subjects survive for 2 years since the start of treatment.


Other Outcome Measures:
  • Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The Quality of Life for a year since the start of treatment.

  • Response Rate (RR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The number of study subjects that have a Partial Response (PR) or Complete Response (CR).

  • Progression-Free-Survival (PFS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The duration of Stable Disease (SD), Partial Response (PR), or Complete Response (CR)

  • Adverse Events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    The incidence of adverse events, as measured by blood tests, signs/symptoms, etc.


Estimated Enrollment: 30
Study Start Date: August 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: G-FLIP+VitaminC, then G-FLIP-DM+VitaminC
G-FLIP in combination with Vitamin C, then G-FLIP-DM in combination with Vitamin C
Drug: G-FLIP
G-FLIP is a combination of Low Doses of Gemcitabine, Fluorouracil [5FU], Leucovorin, Irinotecan, and Oxaliplatin
Other Names:
  • Low doses of Gemcitabine
  • Low dose Fluorouracil [5FU]
  • Leucovorin
  • Low dose Irinotecan
  • Low dose Oxaliplatin)
Drug: G-FLIP-DM
G-FLIP-DM is low doses of Gemcitabine, Fluorouracil [5FU], Leucovorin, Irinotecan, Oxaliplatin, Docetaxel and Mitomycin C
Other Names:
  • Low dose Gemcitabine
  • Low dose Fluorouracil or 5FU
  • Leucovorin
  • Low dose Irinotecan
  • Low dose Oxaliplatin
  • Low dose Docetaxel
  • Low dose Mitomycin C
Dietary Supplement: Vitamin C
High dose of Vitamin C, used in combination with G-FLIP and then G-FLIP-DM
Other Name: Ascorbic Acid
Active Comparator: G-FLIP, then G-FLIP-DM
G-FLIP alone, then G-GLIP-DM alone
Drug: G-FLIP
G-FLIP is a combination of Low Doses of Gemcitabine, Fluorouracil [5FU], Leucovorin, Irinotecan, and Oxaliplatin
Other Names:
  • Low doses of Gemcitabine
  • Low dose Fluorouracil [5FU]
  • Leucovorin
  • Low dose Irinotecan
  • Low dose Oxaliplatin)
Drug: G-FLIP-DM
G-FLIP-DM is low doses of Gemcitabine, Fluorouracil [5FU], Leucovorin, Irinotecan, Oxaliplatin, Docetaxel and Mitomycin C
Other Names:
  • Low dose Gemcitabine
  • Low dose Fluorouracil or 5FU
  • Leucovorin
  • Low dose Irinotecan
  • Low dose Oxaliplatin
  • Low dose Docetaxel
  • Low dose Mitomycin C

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically and cytologically confirmed metastatic (Stage IV) pancreatic adenocarcinoma and have never been treated with any 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.
  • Prior treatment with any chemotherapy for metastatic 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01905150

Contacts
Contact: Azriel Hirschfeld, MD 917-686-3953 azihirsch@yahoo.com

Locations
United States, New York
Bruckner Oncology Not yet recruiting
Bronx, New York, United States, 10469
Contact: Azriel Hirschfeld, MD    917-686-3953    azihirsch@yahoo.com   
Sponsors and Collaborators
Bruckner Oncology
Investigators
Principal Investigator: Azriel Hirschfeld, MD Bruckner Oncology
  More Information

Publications:
Bruckner H, Simon K, Hrehorovich V. Low-dose sequential multi-drug regimens for advanced pancreatic cancer. Journal of Clinical Oncology, 2008, 26 (15S, May 20 Supplement) 15568 (Abstract)

Responsible Party: Bruckner Oncology
ClinicalTrials.gov Identifier: NCT01905150     History of Changes
Other Study ID Numbers: 119005
Study First Received: July 18, 2013
Last Updated: July 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bruckner Oncology:
pancreatic Cancer
G-FLIP, Gemcitabine 5FU Leucovorin Irinotecan Oxaliplatin
G-FLIP-DM (G-FLIP + Low doses Docetaxel and Mitomycin C)
Vitamin C (ascorbic acid)

Additional relevant MeSH terms:
Ascorbic Acid
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Mitomycins
Mitomycin
Gemcitabine
Oxaliplatin
Irinotecan
Docetaxel
Fluorouracil
Leucovorin
Vitamins
Levoleucovorin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014