Radiation Therapy and Capecitabine With or Without Curcumin Before Surgery in Treating Patients With Rectal Cancer
Condition: Rectal Mucinous Adenocarcinoma; Rectal Signet Ring Cell Adenocarcinoma; Recurrent Rectal Carcinoma; Stage IIA Rectal Cancer AJCC v7; Stage IIB Rectal Cancer AJCC v7; Stage IIC Rectal Cancer AJCC v7; Stage IIIA Rectal Cancer AJCC v7; Stage IIIB Rectal Cancer AJCC v7; Stage IIIC Rectal Cancer AJCC v7
MeSH terms: Adenocarcinoma; Rectal Neoplasms; Adenocarcinoma, Mucinous; Cystadenocarcinoma; Carcinoma, Signet Ring Cell
Intervention: Capecitabine; Curcumin; Laboratory Biomarker Analysis; Pharmacological Study; Placebo; Quality-of-Life Assessment; Radiation Therapy
Intervention description: Given PO; Given PO; Correlative studies; Optional correlative studies; Given PO; Ancillary studies; Undergo radiation therapy
Intervention MeSH terms: Curcumin; Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies how well radiation therapy and capecitabine with or
      without curcumin before surgery works in treating patients with rectal cancer. Drugs such as
      curcumin may make tumor cells more sensitive to radiation therapy. Drugs used in
      chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells,
      either by killing the cells or by stopping them from dividing. Giving chemotherapy with
      radiation therapy before surgery may make the tumor smaller and reduce the amount of normal
      tissue that needs to be removed. It is not yet known whether chemotherapy and radiation
      therapy is more effective with or without curcumin when given before surgery in patients with
      rectal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients must have clinical stage T3,4 N0,1,2 or T2N1,2 adenocarcinoma of the
             rectum; patients will be clinically staged using endorectal ultrasound, pelvic
             computed tomography (CT) or magnetic resonance imaging (MRI), and physical examination

          -  Histology must be confirmed with review by the Department of Pathology at MD Anderson
             Cancer Center (MDACC)

          -  All patients must have no distant metastatic disease in the liver, peritoneum, lungs,
             or paraaortic lymph nodes

          -  Patients must have a performance status (Karnofsky scale) of 70% or greater

          -  Absolute neutrophil count (ANC) > 1200 cells/mm^3

          -  Platelets > 100,000/mm^3

          -  Total serum bilirubin < 2 mg/dl

          -  Blood urea nitrogen (BUN) < 30 mg/dl

          -  Creatinine < 1.5 mg/dl or creatinine clearance > 50cc/min (estimated as calculated
             with Cockcroft-Gault equation)

          -  Patients must have signed informed consent indicating that they are aware of the
             investigational nature of the study, and are aware that participation is voluntary;
             patients must also agree to refrain from use of additional herbal supplements during
             the course of the study

          -  Patients will agree to continue contraception for 30 days from the date of the last
             study drug administration; sexually active males must practice contraception during
             the study

          -  Postmenopausal woman must have been amenorrheic for at least 12 months to be
             considered of non-childbearing potential

        Exclusion Criteria:

          -  Prior complete course up to 5 Gy of radiotherapy to the pelvis

          -  Pregnant or lactating woman; women of childbearing potential who have not undergone a
             hysterectomy with either a positive or no pregnancy test at baseline; women / men of
             childbearing potential not using a reliable and appropriate contraceptive method
             (oral, injectable, or implantable hormonal contraceptive; tubal ligation;
             intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner)

          -  Treatment for other carcinomas within the last five years, except cured non-melanoma
             skin and treated in-situ cervical cancer

          -  Patients with uncontrolled intercurrent illness including, but not limited to, ongoing
             or requiring IV antibiotics, cardiac disease New York Heart Association (NYHA) class
             III or IV, unstable angina pectoris, unstable cardiac arrhythmia or tachycardia (heart
             rate > 100 beats/minute), or psychiatric illness/ social situations that would limit
             compliance with the study requirements are excluded

          -  Other serious uncontrolled medical conditions that the investigator feels might
             compromise study participation

          -  Major surgery within 4 weeks of the start of study treatment

          -  Prior unanticipated severe reaction to fluoropyrimidine therapy or known
             hypersensitivity to 5-fluorouracil or capecitabine or curcumin

          -  Concurrent use of Coumadin other than low dose (1 mg) Coumadin used for line patency;
             patients on Coumadin must be changed to Lovenox at least 1 week prior to starting
             capecitabine

          -  Concurrent use of cimetidine, allopurinol, or aluminium hydroxide and magnesium
             hydroxide-containing antacids such as Maalox

          -  Sorivudine and brivudine use within 4 weeks of the start of study treatment