Clinical trial NCT00107315: Bevacizumab and Capecitabine as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer
Official title: A Phase II Study of Capecitabine and Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: recurrent colon cancer
stage IV colon cancer
recurrent rectal cancer
stage IV rectal cancer
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2005-04-06
Enrollment: 16
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to Progression
timeFrame: 1 year
Secondary outcomes:
measure: Response Rate
timeFrame: 1 year
measure: Median Survival
timeFrame: 1 year
measure: Toxicity
timeFrame: 1 year
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Marwan Fakih, MD
role: PRINCIPAL_INVESTIGATOR
References: