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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00107315
• Other study ID #: I 22204
• Secondary ID: RPCI-I-22204GENE
• Status: Terminated
• Phase: Phase 2
• First received: April 5, 2005
• Last updated: June 3, 2014
• Start date: July 2004

Study information

• Verified date: June 2014
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Biological:
• bevacizumab

Drug:
• capecitabine

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Progression		1 year	No
Secondary	Response Rate	Overall Response (OR) = CR + PR.	1 year	No
Secondary	Median Survival		1 year	No
Secondary	Toxicity	Number of participants with an adverse event.; Please refer to the adverse event reporting for more detail.	1 year	Yes