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An Open Label, Phase II Study of Capecitabine (Xeloda) Plus Conformal Radiotherapy for Patients With Locally Advanced, Non-Metastatic Rectosigmoid Carcinoma

Phase 4
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

An Open Label, Phase II Study of Capecitabine (Xeloda) Plus Conformal Radiotherapy for Patients With Locally Advanced, Non-Metastatic Rectosigmoid Carcinoma

Patients will all receive the combined treatment of 3-D external radiation therapy plus
Xeloda®. External Radiation Therapy to the pelvis, lower abdomen and rectal area will be
given once a day, five days a week, Monday through Friday, for about five to six weeks using
three dimensional techniques.

Xeloda® (oral chemotherapy) is a pill taken by mouth. This medication will be taken during
the course of radiation therapy on days that radiation treatments are given. Xeloda pills
will be taken twice daily beginning with the first day of radiation therapy treatments and
ending on the last day of radiation therapy treatment.

The following tests and procedures are part of regular medical treatment (standard care) for
the disease and are also required for this study:

- physical examinations, sometimes including a digital rectal exam

- blood tests including a (blood) pregnancy test will be done before starting treatment
if the patient is a woman able to have children.

- urinalysis

- ECG (heart tracing)

- chest X-ray

- ultrasound, which produces pictures of the rectal area using sound waves· CT scan of
the pelvis and abdomen

Some people may need surgery, others may require more chemotherapy, and others may require
no additional treatment depending on how their tumor responded to the Xeloda® and radiation
therapy treatments.

Patients will also be asked to complete two questionnaires about their fatigue, general
quality of life, and bowel functioning.

Inclusion Criteria:

- Provide written informed consent prior to study-specific screening procedures, with
the understanding that the patient has the right to withdraw from the study at any
time, without prejudice.

- Age >18 years

- Ambulatory outpatients (if applicable), with Karnofsky performance status of >60

- Histologically or cytologically confirmed locally advanced nonmetastatic T3-4 N0-3 M0
carcinomas of the rectosigmoid.

- Surgical exploration without resection is permissible.

- Protocol Specific Laboratory Values as defined in section 4.2

- Has a negative serum pregnancy test within 7 days prior to start of therapy (female
patients of childbearing potential).

- Have concomitant medications been reviewed with patient to address contraindicated
medications described in section 7.8 and have precautions been taken as recommended
for each drug? Includes Allopurinol, Cimetidine, Sorivudine and Brivudine,
Anticoagulants, Phenytoin, and Laxatives.

Exclusion Criteria:

Patients who fulfill any of the following criteria will be excluded:

- Pregnant or lactating woman. Woman of childbearing potential with either a positive
or no pregnancy test at baseline. Woman or 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

- Life expectancy < 3 months.

- Serious, uncontrolled, concurrent infection(s).

- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity
to 5-fluorouracil, or known DPD deficiency.

- Completion of previous chemotherapy regimen < four weeks prior to the start of study
treatment, or with related toxicities unresolved prior to the start of study

- Treatment for other carcinomas within the last five years, except cured non-melanoma
skin and treated in-situ cervical cancer.

- Participation in any investigational drug study within 4 weeks preceding the start of
study treatment.

- Clinically unstable cardiac disease (e.g. congestive heart failure, symptomatic
coronary artery disease and cardiac arrhythmias not well controlled with medication)
or myocardial infarction within the last 12 months.

- Evidence of metastases or history of uncontrolled seizures, central nervous system
disorders or psychiatric disability judged by the investigator to be clinically
significant, precluding informed consent, or interfering with compliance of oral drug

- Other serious uncontrolled medical conditions that the investigator feels might
compromise study participation.

- Major surgery within 4 weeks of the start of study treatment, without complete
recovery (e.g., delayed wound healing).

- Lack of physical integrity of the upper gastrointestinal tract or malabsorption

- Known, existing uncontrolled coagulopathy

- Any of the following laboratory values:

- Abnormal hematologic values (neutrophils < 1.5 x 109/L, platelet count < 100 x

- Impaired renal function (estimated creatinine clearance <30ml/min as calculated
with Cockroft-Gault equation.

- Note: In patients with moderate renal impairment (estimated creatinine clearance
30-50 mL/min) at baseline, a dose reduction to 75% of the capecitabine starting dose
is recommended.

- Serum bilirubin > 1.5 x upper normal limit.

- ALT (SGOT), AST (SGPT) > 2.5 x upper normal limit (or > 5 x upper normal limit
in the case of liver metastases).

- Alkaline phosphatase > 2.5 x upper normal limit (or > 5 x upper normal limit in
the case of liver metastases or > 10 x upper normal limit in the case of bone

- Unwillingness to give written informed consent or HIPAA privacy authorization.

- Unwillingness to participate or inability to comply with the protocol requirements
for the duration of the study.

- Patient taking a contraindicated medication(s) described in section 6.2.8 (see
inclusion criteria #8 for list of agents) and no appropriate substitute agent is
available, or patient unable or refuses to take substitute agent.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response and resectability of tumor following treatment with radiation and capecitabine (Xeloda).

Principal Investigator

Ismail Kazem, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James A. Haley Veterans Administration Hospital


United States: Federal Government

Study ID:




Start Date:

February 2005

Completion Date:

January 2007

Related Keywords:

  • Colorectal Cancer
  • Colon cancer
  • Rectal cancer
  • Carcinoma
  • Colorectal Neoplasms



James A. Haley Veterans Administration Hospital Tampa, Florida  33612