Ascorbic Acid and Combination Chemotherapy in Treating Patients With Locally Advanced or Recurrent Pancreatic Cancer That Cannot Be Removed by Surgery
Condition: Pancreatic Adenocarcinoma; Recurrent Pancreatic Carcinoma; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer; Unresectable Pancreatic Carcinoma
MeSH terms: Carcinoma; Pancreatic Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This pilot clinical trial studies the side effects of ascorbic acid and combination
      chemotherapy in treating patients with pancreatic cancer that has spread to other places in
      the body, has come back, or cannot be removed by surgery. Nutrients found in food and dietary
      supplements, such as ascorbic acid, may improve the tolerability of chemotherapy regimens.
      Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, and oxaliplatin,
      work in different ways to stop the growth of tumor cells, either by killing the cells, by
      stopping them from dividing, or by stopping them from spreading. Giving ascorbic acid and
      combination chemotherapy may work better in treating patients with pancreatic cancer.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine safety of intravenous ascorbic acid in combination with fluorouracil,
      irinotecan hydrochloride, leucovorin calcium, and oxaliplatin (FOLFIRINOX) as defined by
      Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 in patients with advanced
      pancreatic cancer.

      SECONDARY OBJECTIVES:

      I. To test feasibility of collecting quality of life (QOL), patient reported outcomes (PRO)
      data and correlative studies on patients with advanced pancreatic cancer.
    

Intervention name(s): Oxaliplatin; Irinotecan Hydrochloride; Leucovorin Calcium; Fluorouracil; Ascorbic Acid
Intervention type(s): Drug; Drug; Drug; Drug; Dietary Supplement
Intervention description(s): Given IV; Given IV; Given IV; Given IV; Given IV
Other intervention name(s): Diaminocyclohexane Oxalatoplatinum; Eloxatin; Dacotin; Dacplat; 61825-94-3; [(1R,-2R)-1,2-cyclohexanediamine-N,N'][oxalato (2--)-O,O']platinum; [Sp-4-2-(1R-trans)]-(1,2,cyclohexanediamine-N,N')[ethanedioato(2--)-O,O']platinum; Ai Heng; Oxalatoplatin; trans-l diaminocyclohexane oxalatoplatinum; 136572-09-3; Campto; Camptosar; Camptothecin 11; 1492-18-8; 3590; 5-Formyl Tetrahydrofolate; 5-Formyl-5,6,7,8-tetrahydrofolic Acid; 5-Formyl-5,6,7,8-tetrahydropteroyl-L-glutamic Acid; Adinepar; Calcifolin; Calcium (6S)-Folinate; Calcium Folinate; Calcium N-(p-((((6RS)-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl)methyl)amino)benzoyl)-L-glutamate (1:1); Calfolex; Calinat; Cehafolin; Citofolin; Citrec; Citrovorum Factor; Cromatonbic Folinico; Dalisol; Disintox; Divical; Ecofol; Emovis; Flynoken A; Folaren; Folaxin; Foliben; Folinic Acid Calcium Salt Pentahydrate; Folix; Lederfolin; Leucosar; N-[4-[[(2-Amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amnio]benzoyl]-L-glutamic Acid; Rescufolin; Tonofolin; Rescuvolin; Wellcovorin; 19893; 2,4-Dioxo-5-fluoropyrimidine; 5-Fluoro-2,4(1H, 3H)-pyrimidinedione; 5-Fluorouracil; AccuSite; Fluracedyl; Fluracil; Fluroblastin; Ribofluor; Ro 2-9757; 2-(1,2-dihydroxyethyl)-4,5-dihydroxy-furan-3-one; 33832; 50-81-7; Asorbicap; C Vitamin; C-Long; Ce-Vi-Sol; Cecon; Cenolate; L-Ascorbic Acid; Vitamin C
Intervention MeSH terms: Calcium, Dietary; Vitamins; Leucovorin; Ascorbic Acid; Tetrahydrofolates; Formyltetrahydrofolates; Fluorouracil; Oxaliplatin; Irinotecan; Camptothecin; Calcium; Levoleucovorin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment