Curcumin With Pre-operative Capecitabine and Radiation Therapy Followed by Surgery for Rectal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00745134
First received: September 2, 2008
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

The goal of this clinical research study is to learn if combining a curcumin preparation with standard radiation therapy and chemotherapy (capecitabine) can help to shrink or slow the growth of rectal cancer. The safety of this combination and whether curcumin can help to decrease some of the side effects of standard radiotherapy and chemotherapy will also be studied.


Condition Intervention Phase
Rectal Cancer
Drug: Curcumin
Drug: Placebo
Radiation: Radiotherapy
Drug: Capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: A Randomized Double Blinded Study of Curcumin With Pre-operative Capecitabine and Radiation Therapy Followed by Surgery for Rectal Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Pathologic Complete Response (pCR) rate [ Time Frame: 18 weeks of treatment prior to surgery, pCR rate evaluated at the time of surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: July 2008
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Radiotherapy + Capecitabine + Curcumin
Radiotherapy 45 Gy once a day, for 5 days in a row for 5-6 weeks (up to 28 treatments in all). Capecitabine 825 mg/m^2 by mouth twice a day only on days of radiation (Monday through Friday). Curcumin 4 gm tablets by mouth twice a day.
Drug: Curcumin
4 gm tablets by mouth twice a day
Radiation: Radiotherapy
45 Gy once a day, for 5 days in a row for 5-6 weeks (up to 28 treatments in all)
Other Names:
  • Radiation Therapy
  • XRT
Drug: Capecitabine
825 mg/m^2 by mouth twice a day only on days of radiation (Monday through Friday).
Other Name: Xeloda
Placebo Comparator: Radiotherapy + Capecitabine + Placebo
Radiotherapy 45 Gy once a day, for 5 days in a row for 5-6 weeks (up to 28 treatments in all). Capecitabine 825 mg/m^2 by mouth twice a day only on days of radiation (Monday through Friday). Placebo tablets by mouth twice a day.
Drug: Placebo
Tablets by mouth twice a day
Radiation: Radiotherapy
45 Gy once a day, for 5 days in a row for 5-6 weeks (up to 28 treatments in all)
Other Names:
  • Radiation Therapy
  • XRT
Drug: Capecitabine
825 mg/m^2 by mouth twice a day only on days of radiation (Monday through Friday).
Other Name: Xeloda

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. 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 CT, and physical examination.
  2. Histology must be confirmed with review by the Department of Pathology at MDACC.
  3. All patients must have no distant metastatic disease in the liver, peritoneum, lungs, or paraaortic lymph nodes.
  4. Patients must have a performance status (Karnofsky scale) of 70% or greater.
  5. Patient must be >/= 18 years of age.
  6. Patients must have ANC > 1200 cells/mm^3, platelets > 100,000/mm^3, total serum bilirubin < 2 mg/dl, BUN <30 mg/dl, creatinine < 1.5 mg/dl or creatinine clearance > 50cc/min (estimated as calculated with Cockcroft-Gault equation). Creatinine Clearance (men) = {(140 - age) x lean body weight (in kg.)}/ {Plasma creatinine (mg/dl) x 72} Creatinine Clearance (women) = 0.85 x {(140 - age) x lean body weight (in kg.)}/ {Plasma creatinine (mg/dl) x 72}
  7. 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.
  8. 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.
  9. Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.

Exclusion Criteria:

  1. Prior complete course up to 5 Gy of radiotherapy to the pelvis.
  2. 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).
  3. Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.
  4. Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or requiring IV antibiotics, cardiac disease NYHA class III or IV, unstable angina pectoris, unstable cardiac arrythmia or tachycardia (heart rate > 100 beats/minute), or psychiatric illness/ social situations that would limit compliance with the study requirements are excluded.
  5. Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
  6. Major surgery within 4 weeks of the start of study treatment.
  7. Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil or capecitabine or curcumin.
  8. 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.
  9. Concurrent use of cimetidine, allopurinol, or aluminium hydroxide and magnesium hydroxide-containing antacids such as Maalox.
  10. Sorivudine and brivudine use within 4 weeks of the start of study treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745134

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Sunil Krishnan, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00745134     History of Changes
Other Study ID Numbers: 2006-0644, P07010
Study First Received: September 2, 2008
Last Updated: November 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Rectum
Rectal Cancer
Colon Cancer
Curcumin
Diferuloylmethane
Capecitabine
Radiation Therapy
RT
XRT
Surgery for Rectal Cancer

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Fluorouracil
Curcumin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 01, 2014