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


Phase 2
70 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to progression

Safety Issue:

No

Principal Investigator

Marwan Fakih, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

I 22204

NCT ID:

NCT00107315

Start Date:

July 2004

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • recurrent colon cancer
  • stage IV colon cancer
  • recurrent rectal cancer
  • stage IV rectal cancer
  • Colorectal Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263