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IV Ascorbic Acid in Advanced Gastric Cancer

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ClinicalTrials.gov Identifier: NCT03015675
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):
Ruihua Xu, Sun Yat-sen University

January 8, 2017
January 10, 2017
May 18, 2017
March 12, 2017
December 2017   (Final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: up to 5 years ]
Time-to-event outcome measure (initial disease progression) measured in days from cycle 1 day 1 to day of first progression as defined by RECIST1.1 criteria from NCI
Same as current
Complete list of historical versions of study NCT03015675 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: up to 5 years ]
    Time to event outcome measure (death), measured in days from cycle 1 day 1
  • Response Rate [ Time Frame: up to 5 years ]
    To utilize CT or PET/CT scans to assess overall tumor response rate (complete and partial response) and evaluate disease progression in subjects with advanced or recurrent RAS mutant colorectal cancer treated with the combination of ascorbic acid and FOLOX/FORFIRI +/- bevacizumab versus treatment with FOLFOX/FORFIRI +/- bevacizumab alone
Same as current
Not Provided
Not Provided
 
IV Ascorbic Acid in Advanced Gastric Cancer
Phase Ⅲ Study of IV Ascorbic Acid in Combination With XELOX vs Treatment With XELOX Alone as First-line Therapy for Advanced Gastric Cancer
Linus Pauling and Dr Ewan Cameron have published two retrospective studies about using high dose vitamin C to treat cancer patients forty years ago. Their studies have shown that high dose vitamin C usage could significantly prolong overall survival of patients with advanced cancer. Recently, preclinical study has shown that human colorectal cancer cells harboring KRAS or BRAF mutations are selectively killed by high levels of ascorbic acid (AA). High dose of AA impairs tumor growth in Apc/KRASG12D mutant mice. Previous phaseⅠclinical trials have found that high dose (1.5g/kg or 90g/m2) iv AA is well tolerated in cancer patients. This protocol is a phase Ⅲ, study of ascorbic acid (AA) infusions combined with treatment with mFOLOX6 versus mFOLOX6 alone as first-line therapy in patients with recurrent or advanced gastric cancer.
Linus Pauling and Dr Ewan Cameron have published two retrospective studies about using high dose vitamin C to treat cancer patients forty years ago. Their studies have shown that high dose vitamin C usage could significantly prolong overall survival of patients with advanced cancer. Recently, preclinical study has shown that human colorectal cancer cells harboring KRAS or BRAF mutations are selectively killed by high levels of ascorbic acid (AA). High dose of AA impairs tumor growth in Apc/KRASG12D mutant mice. Previous phaseⅠclinical trials have found that high dose (1.5g/kg or 90g/m2) iv AA is well tolerated in cancer patients. This protocol is a phase Ⅲ, study of ascorbic acid (AA) infusions combined with treatment with mFOLOX6 versus mFOLOX6 alone as first-line therapy in patients with recurrent or advanced gastric cancer.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastric Cancer
  • Drug: ascorbic acid
    20g/day, D1-3, every 2 weeks
    Other Name: vitamin C
  • Drug: mFOLFOX6

    mFOLFOX6

    • Oxaliplatin 85 mg/m² d1 concurrent with
    • Leucovorin 400 mg/m², followed by
    • Bolus 5FU 400 mg/m² , followed by
    • Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks
    Other Name: chemotherapy
  • Experimental: Ascorbic Acid with mFOLFOX6 group

    Ascorbic Acid with mFOLFOX6 Ascorbic Acid (20g/day, D1-3) every 2 weeks

    mFOLOX6:

    • Oxaliplatin 85 mg/m² d1 concurrent with
    • Leucovorin 400 mg/m², followed by
    • Bolus 5FU 400 mg/m² , followed by
    • Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks
    Interventions:
    • Drug: ascorbic acid
    • Drug: mFOLFOX6
  • Active Comparator: mFOLFOX6 group

    mFOLOX6:

    • Oxaliplatin 85 mg/m² d1 concurrent with
    • Leucovorin 400 mg/m², followed by
    • Bolus 5FU 400 mg/m² , followed by
    • Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks
    Intervention: Drug: mFOLFOX6
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Same as current
December 2019
December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Age≥18 years, ≤75 years; Histologically proven metastatic adenocarcinoma of stomach (stage 4 disease), unresectable metastatic disease; G6PD status > lower limit of normal; Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2; Life expectancy of at least 12 weeks; ANC ≥1,500/mm3; Hemoglobin > 8g/dL; platelet ≥ 100,000/mm3; Laboratory at baseline evaluation for inclusion in the study: creatinine ≤1.5X upper limit [if the creatinine is elevated, but ≤1.5X the ULN, a 24 hour ;creatinine clearance will be obtained, Creatinine clearance > 50 mL/min (calculated according to Cockroft and Gault)]; Transaminase (AST/ALT) ≤2.5X upper limit of normal and bilirubin levels ≤1.5X upper limit of normal without liver metastasis; Transaminase (AST/ALT) ≤5X upper limit of normal and bilirubin levels ≤1.5X upper limit of normal with liver metastasis; Women of childbearing potential will confirm a negative pregnancy test and must practice effective contraception during the study; Written informed consent

Exclusion Criteria:

Prior treatment for metastatic disease (adjuvant therapy with fluoropyrimidines +/-oxaliplatin based regimens allowed if stopped 12 months prior to registration on study); Surgery (excluding diagnostic biopsy) or irradiation within 3 weeks prior to study entry; Administration of any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment; Concurrent chronic systemic immune therapy, chemotherapy, radiation therapy (palliative radiation therapy allowed) or hormone therapy not indicated in the study protocol; Brain metastasis (known or suspected); Pregnant or lactating women; Other uncontrolled concomitant illness, including serious uncontrolled intercurrent infection; Known allergy or any other adverse reaction to any of the drugs or to any related compound; Previous (within 5 years) or concurrent malignancies at other sites with the exception of surgically cured or adequately treated carcinoma in-situ of the cervix and basal cell carcinoma of the skin; Patients who are on strong inducers of CYP3A4 which include but are not limited to: Aminoglutethimide, Bexarotene, Bosentan, Carbamazepine, Dexamethasone, Efavirenz, Fosphenytoin, Griseofulvin, Modafinil, Nafcillin, Nevirapine, Oxcarbazepine, Phenobarbital, Phenytoin, Primidone, Rifabutin, Rifampin, Rifapentine, St. John's wort; Medical, social or psychological condition which, in the opinion of the investigator, would not permit the patient to complete the study or sign meaningful informed consent; Organ allograft requiring immunosuppressive therapy; Patients with HIV infection

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact: Feng Wang, MD.,PhD. +862087343795 wangfeng@sysucc.org.cn
China
 
 
NCT03015675
GCV 001
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: Undecided
Ruihua Xu, Sun Yat-sen University
Sun Yat-sen University
Not Provided
Principal Investigator: Rui-hua Xu, MD.,PhD. Sun Yat-sen University
Sun Yat-sen University
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP