A Randomized Double Blinded Study of Curcumin With Pre-operative Capecitabine and Radiation Therapy Followed by Surgery for Rectal Cancer
18 Years
N/A
Both
Rectal Cancer
Trial Information
A Randomized Double Blinded Study of Curcumin With Pre-operative Capecitabine and Radiation Therapy Followed by Surgery for Rectal Cancer
The Study Therapy:
Radiation therapy and capecitabine are commonly used treatments for rectal cancer.
Curcumin is the active ingredient in the spice, turmeric, which is commonly used in Indian
cooking. Researchers hope the curcumin will interfere with the coping mechanism that cancer
cells use to avoid being killed by radiation, thus allowing the radiation to have a greater
likelihood of killing the cancer cells.
Study Therapy Administration:
If you are found to be eligible to take part in this study, you will receive radiation
therapy once a day, for 5 days in a row (Monday-Friday) for 5-6 weeks (up to 28 treatments
in all). You will take capecitabine capsules by mouth twice a day, at morning and night, on
each of the days that you receive radiation therapy. These capsules will not be taken on
Saturday or Sunday. These capsules should be taken within 30 minutes after eating and with
a full glass of water, but not with fruit juice.
You will also be randomly assigned (as in the roll of dice) to one of two groups.
Participants in one group will receive additional treatment with a curcumin preparation.
Participants in the other group will receive a placebo. The placebo is a substance that
looks like curcumin but has no active ingredients. You have a 2 in 3 chance of getting
curcumin. This means that for every 3 participants enrolled, 2 will get curcumin and 1 will
get placebo. Neither you nor your doctor will know to which group you are assigned.
You will take curcumin/placebo capsules by mouth twice a day, every day that you receive
chemotherapy and radiation therapy, on an empty stomach. The first dose of the day should
be taken about 1 hour before radiation therapy and the second dose should be taken later in
the evening. These capsules must be taken on Saturday and Sunday as well. The placebo or
curcumin treatment will continue after you complete chemotherapy and radiation therapy and
for an additional 6 weeks.
Study Visits:
Every week while you are having chemotherapy and radiation treatments, you will have the
following procedures performed:
- You will have a physical exam.
- Blood (about 2 tablespoons) will be drawn to check for side effects from chemotherapy
and radiation therapy.
- You will be asked about any side effects you are experiencing.
- A plain X-ray film will be taken to check if you have been positioned correctly.
Questionnaires:
You will be asked to fill out 2 questionnaires about your symptoms at the time of
enrollment, 1 time a week while receiving radiation therapy, and just before surgery. The 2
questionnaires should take a total of about 10 minutes to fill out.
Length of Treatment:
You will receive up to 11 1/2 weeks of curcumin or placebo on this study. You will be taken
off study if the disease gets worse or intolerable side effects occur.
End-of-Treatment Visit:
About 6-12 weeks after completing radiation therapy, you will have a follow-up visit. At
this visit, you will have a physical exam. Blood (about 2 tablespoons) will be drawn for
routine tests. You will be asked about any side effects you are experiencing. You will be
evaluated by a surgeon at this time. If the tumor can be surgically removed, you will be
offered surgery to remove the tumor, as is standard of care for the disease. In addition, no
matter when you had surgery, at about 1 month (+/- 1 week) after finishing the study drug,
you will receive a telephone call from the study staff. They will ask you about any side
effects you are experiencing that may be related to the study drug.
Your medical record will be reviewed from time to time to check your health status
information.
This is an investigational study. Capecitabine, radiation therapy and curcumin are all
commercially available. Capecitabine is FDA approved for treating colon cancer after
surgery, and for treating rectal cancer (a specific type of colon cancer) that has spread.
Radiation therapy is a standard treatment for rectal cancers. The use of curcumin with
capecitabine and radiation therapy in this study is investigational. At this time, the
combination is being used in research only.
Up to 45 patients will take part in this study. All will be enrolled at M. D. Anderson.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Outcome Measure:
Pathologic Complete Response (pCR) rate
Outcome Time Frame:
18 weeks of treatment prior to surgery, pCR rate evaluated at the time of surgery
Safety Issue:
Yes
Principal Investigator
Sunil Krishnan, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
2006-0644
NCT ID:
NCT00745134
Start Date:
July 2008
Completion Date:
Related Keywords:
- Rectal Cancer
- Rectum
- Rectal Cancer
- Colon Cancer
- Curcumin
- Diferuloylmethane
- Capecitabine
- Radiation Therapy
- RT
- XRT
- Surgery for Rectal Cancer
- Rectal Neoplasms
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
