Curcumin With Pre-operative Capecitabine and Radiation Therapy Followed by Surgery for Rectal Cancer
Summary
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.
Description
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.
Screening Tests:
Before you can start treatment on this study, you will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:
- You will have a complete physical exam.
- Blood (about 2 tablespoons) will be drawn for routine tests.
- You will be asked how well you are able to perform the normal activities of daily living.
- Chest x-rays and computed tomography (CT) scans of the abdomen and pelvis will be done to check the status of the disease.
- You will have a colonoscopy performed within 3 months and an endoscopic ultrasound done within 30 days of enrollment of the study. These are standard procedures, and you will be asked to sign separate consent forms that will describe the procedures and their risks.
- Women who are able to have children must have a negative urine pregnancy test.
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.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Conditions
Rectal Cancer
Intervention
Curcumin, Placebo, Radiotherapy, Capecitabine
Location
UT MD Anderson Cancer Center
Houston
Texas
United States
77030
Status
Recruiting
Source
M.D. Anderson Cancer Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00745134
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Radiotherapy, Adjuvant
Radiotherapy given to augment some other form of treatment such as surgery or chemotherapy. Adjuvant radiotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.
Curcumin
A yellow-orange dye obtained from tumeric, the powdered root of CURCUMA longa. It is used in the preparation of curcuma paper and the detection of boron. Curcumin appears to possess a spectrum of pharmacological properties, due primarily to its inhibitory effects on metabolic enzymes.
Rectal Neoplasms
Tumors or cancer of the RECTUM.
Radiotherapy Dosage
The total amount of radiation absorbed by tissues as a result of radiotherapy.
Radiation Oncology
A subspecialty of medical oncology and radiology concerned with the radiotherapy of cancer.
Clinical Trials
Dual REctcal Angiogenesis or MEK Inhibition radioTHERAPY Trial
To determine the maximum tolerated dose (MTD) of AZD6244 or AZD2171 when combined with pre-operative capecitabine and radiotherapy in patients with locally advanced rectal cancer.
This is a nonrandomised pilot trial to establish the role of intravenous cetuximab when added to a schedule of capecitabine plus pelvic radiation in patients who have locally advanced prim...
Preoperative Chemoradiotherapy With Capecitabine Plus Irinotecan in Rectal Cancer
This study is to evaluate the pathologic complete response rate to pre-operative concurrent chemoradiotherapy with capecitabine plus irinotecan in resectable rectal cancer
A Phase II study aimed to evaluate the efficacy and toxicity of preoperative chemoradiotherapy with capecitabine in locally advanced resectable rectal cancer.
This is a phase II study of induction chemotherapy (capecitabine, oxaliplatin and cetuximab (erbitux)) followed by capecitabine, oxaliplatin, cetuximab and radiotherapy followed by surgery...
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