Bevacizumab and Capecitabine as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with capecitabine may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with capecitabine works as first-line therapy in treating older patients with metastatic colorectal cancer.

Detailed Description
-----------------
OBJECTIVES: Primary Determine the time to disease progression in older patients with metastatic colorectal cancer treated with bevacizumab and capecitabine as first-line therapy. Secondary Determine the response rate in patients treated with this regimen. Determine the median survival of patients treated with this regimen. Determine the toxic effects of this regimen in these patients. OUTLINE: This is an open-label study. Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral capecitabine twice daily on days 1-7. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 13-16 months.

Official Title
-----------------
A Phase II Study of Capecitabine and Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Biological: bevacizumab
* Drug: capecitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically* or cytologically* confirmed colorectal cancer Site of primary tumor must have been confirmed by endoscopy, radiography, or surgery Metastatic disease NOTE: *Patients with a history of surgically treated colorectal cancer who subsequently develop recurrent metastatic disease do not require histologic or cytologic confirmation of metastatic disease unless an interval of > 5 years has elapsed between initial primary surgery and the development of metastases Measurable disease At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan No known curative therapy exists No history or evidence of CNS disease by physical exam (e.g., primary brain tumor or brain or CNS metastases) PATIENT CHARACTERISTICS: Age 70 and over Performance status ECOG 0-1 Life expectancy More than 3 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9 g/dL No bleeding diathesis or coagulopathy Hepatic Bilirubin normal AST and ALT ≤ 3 times upper limit of normal (ULN) INR < 1.5 (unless on therapeutic anticoagulants) No unstable or uncompensated hepatic disease Renal Creatinine < 1.2 times ULN OR Creatinine clearance > 60 mL/min No unstable or uncompensated renal disease Cardiovascular No history of stroke No uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg on medication) No myocardial infarction within the past year No New York Heart Association class II-IV congestive heart failure No unstable angina No serious cardiac dysrhythmia requiring medication No other clinically significant cardiovascular disease No other unstable or uncompensated cardiac disease Pulmonary No unstable or uncompensated respiratory disease Other Fertile patients must use effective contraception Able to receive oral medication No known hypersensitivity to fluorouracil or capecitabine No known dihydropyrimidine dehydrogenase deficiency No seizures not controlled by standard medical therapy No serious nonhealing wound, ulcer, or bone fracture No other malignancy within the past 5 years except completely excised nonmelanoma skin cancer (with no evidence of recurrent disease) or carcinoma in situ of the cervix No other severe or uncontrolled systemic disease PRIOR CONCURRENT THERAPY: Biologic therapy No prior bevacizumab Chemotherapy Prior adjuvant fluorouracil and leucovorin calcium allowed provided the last treatment was administered > 6 months before the development of metastatic disease No prior chemotherapy for metastatic colon cancer No prior irinotecan or oxaliplatin Endocrine therapy Not specified Radiotherapy Not specified Surgery See Disease Characteristics More than 28 days since prior and no concurrent major surgery More than 28 days since prior open biopsy More than 7 days since prior fine needle aspiration or core biopsy Other More than 4 weeks since prior and no concurrent participation in another experimental drug study More than 30 days since prior non-approved or investigational drugs

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral capecitabine twice daily on days 1-7 | Biological: bevacizumab<br> <br> Drug: capecitabine<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progression |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate | Overall Response (OR) = CR + PR. | 1 year | 
| Median Survival |  | 1 year | 
| Toxicity | Number of participants with an adverse event. Please refer to the adverse event reporting for more detail. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer