A Phase I/II Trial of Proton Therapy With Concurrent Capecitabine for Locally Advanced and Recurrent Rectal Cancer
18 Years
N/A
Both
Rectal Cancer
Trial Information
A Phase I/II Trial of Proton Therapy With Concurrent Capecitabine for Locally Advanced and Recurrent Rectal Cancer
Proton beams can be used to deliver a high dose of radiation to the treatment area while
sparing surrounding normal tissues. Capecitabine is a drug that interferes with the growth
of cancer cells.
Before you can start treatment on this study, you will have what are called "screening
tests." These tests will help the doctor decide if you are eligible to take part in this
study. You will have a complete physical exam. Blood (about 2 tablespoons) will be drawn
for routine tests. Urine will be collected for routine tests. Chest x-rays and computed
tomography (CT) scans of the abdomen (stomach area) and pelvis will be done. Women who are
able to have children must have a negative blood or urine pregnancy test.
If you are found to be eligible to take part in this study, you will receive radiation
therapy 1 time a day, for 5 days in a row (Monday-Friday) for 6 -7 weeks (30-35 treatments
in all). You will take the chemotherapy drug, capecitabine, by mouth 2 times a day, at
morning and night, on each of the days that you receive radiation therapy. These pills will
not be taken on Saturday or Sunday. These pills should be taken within 30 minutes of eating
and with a full glass of water.
During the study, every week you will have a physical exam and blood (about 2 teaspoons)
will be drawn to check for side effects from chemotherapy and radiation therapy. You will be
asked about any side effects you are experiencing.
You will be evaluated by a surgeon 4-6 weeks after the completion of treatment. Those with
tumors that can be surgically removed will have surgery to remove the tumor 6-8 weeks after
completion of treatment, as they would for the standard of care for their disease.
You will be taken off study if the disease gets worse or intolerable side effects occur.
Two (2) weeks after completing radiation therapy, you will have a follow-up visit. At this
visit, you will have a physical exam. Blood (about 2 teaspoons) will be collected for
routine tests. You will be asked about any side effects you are experiencing. Six (6)
weeks after completing radiation therapy, you will have a follow-up visit. At this visit,
you will have a physical exam, chest x-ray, and CT scan of your abdomen and pelvis. Blood
(about 2 teaspoons) and urine will be collected for routine tests. You will be asked about
any side effects you are experiencing.
After finishing treatment, you will have a follow-up visit every 3 months for the first 2
years, and every 6 months after that. At each visit, you will have a physical exam. Blood
(about 2 teaspoons) and urine will be collected for routine tests. You will have a chest
x-ray and CT scan of the abdomen and pelvis. You will be asked about any side effects you
are experiencing.
One (1) year after you finish treatment, you will also have a colonoscopy or sigmoidoscopy.
You will receive a separate consent for these procedures.
After participation in the study is over, you will have follow-up evaluation as needed for
standard of care.
This is an investigational study. Capecitabine is FDA approved for treating colon cancer
after surgery, and for treating metastatic colorectal cancer. The use of capecitabine with
proton beam therapy in this study is investigational. About 50 patients will take part in
this study. All will be enrolled at M. D. Anderson.
Inclusion Criteria:
1. All patients must have clinical stage T4 or recurrent adenocarcinoma of the rectum.
Patients will be regarded as having clinical stage T4 if there is evidence of
invasion of other structures on one or more of the following: endorectal ultrasound,
pelvic CT, and physical examination, including pelvic examination
2. Histology must be confirmed with review by the Department of Pathology at UT MD
Anderson Cancer Center.
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, and be
able to tolerate the proposed radiation and chemotherapy regimen.
5. There are no age restrictions for this protocol.
6. Patients must have WBC > 4000 cells/mm^3, platelets > 150,000/mm^3, total serum
bilirubin < 2 mg/dl, BUN <30 mg/dl, creatinine < 1.5 mg/dl and creatinine clearance >
50cc/min (estimated as calculated with Cockcroft-Gault equation).
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 sign a study-specific consent form, which is attached to this protocol.
Exclusion Criteria:
1. Prior radiotherapy to the pelvis.
2. Pregnant or lactating woman. Woman of childbearing potential with either a positive
or no pregnancy test at baseline. Woman / men of childbearing potential not using a
reliable and appropriate contraceptive method. (Postmenopausal woman must have been
amenorrheic for at least 12 months to be considered of non-childbearing potential).
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.
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 active infection, cardiac disease NYHA class III or IV, unstable angina
pectoris, unstable cardiac arrythmia or tachycardia (heart rate > 100 beats/minute),
poorly controlled hypertension (systolic blood pressure > 160 mm Hg or diastolic
blood pressure > 100 mm Hg) 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, without complete
recovery.
7. Prior unanticipated severe reaction to fluoropyrimidine therapy or known
hypersensitivity to 5-fluorouracil or capecitabine.
8. Patients on coumadin must be changed to Lovenox at least 1 week prior to starting
capecitabine. Low dose (1 mg) coumadin is allowed.
9. Aluminium hydroxide and magnesium hydroxide-containing antacids such as Maalox must
be stopped during this study.
10. Patients
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum Tolerated Dose (MTD)
Outcome Description:
MTD of a fixed dose of capecitabine (825 mg/m²) and 3 escalating doses of proton radiotherapy (5400, 5940, 6300 cobalt centiGray equivalent) as measured by dose-limiting toxicities using the continual reassessment method (CRM).
Outcome Time Frame:
2 weeks after completion of radiotherapy
Safety Issue:
Yes
Principal Investigator
Prajnan Das, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2005-0657
NCT ID:
NCT00503932
Start Date:
July 2007
Completion Date:
April 2008
Related Keywords:
- Rectal Cancer
- Rectal Cancer
- Capecitabine
- Proton Therapy
- Adenocarcinoma of the rectum
- Gastrointestinal
- Proton Radiotherapy
- Rectal Neoplasms
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