Skip to content

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

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00107315
Enrollment
16
Registered
2005-04-06
Start date
2004-07-31
Completion date
Unknown
Last updated
2014-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer

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.

Interventions

BIOLOGICALbevacizumab
DRUGcapecitabine

Sponsors

Roswell Park Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Time to Progression1 year

Secondary

MeasureTime frameDescription
Response Rate1 yearOverall Response (OR) = CR + PR.
Median Survival1 year
Toxicity1 yearNumber of participants with an adverse event. Please refer to the adverse event reporting for more detail.

Countries

United States

Participant flow

Participants by arm

ArmCount
Combination of Capecitabine and Bevacizumab
Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
16
Total16

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event4
Overall StudyDisease Progression9
Overall StudyWithdrawal by Subject2

Baseline characteristics

CharacteristicCombination of Capecitabine and Bevacizumab
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
16 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age, Continuous78 years
STANDARD_DEVIATION 4.9
Sex: Female, Male
Female
11 Participants
Sex: Female, Male
Male
5 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
16 / 16
serious
Total, serious adverse events
11 / 16

Outcome results

Primary

Time to Progression

Time frame: 1 year

Population: Due to the study's early termination and inadequate number of patients, no patients were analyzed.

Secondary

Median Survival

Time frame: 1 year

Population: Due to the study's early termination and inadequate number of patients, no patients were analyzed.

Secondary

Response Rate

Overall Response (OR) = CR + PR.

Time frame: 1 year

Population: Due to the study's early termination and inadequate number of patients, no patients were analyzed.

Secondary

Toxicity

Number of participants with an adverse event. Please refer to the adverse event reporting for more detail.

Time frame: 1 year

Population: Due to the study's early termination and inadequate number of patients, no patients were analyzed.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026