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

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bevacizumab
capecitabine
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral capecitabine twice daily on days 1-7

Outcomes

Primary Outcome Measures

Time to Progression

Secondary Outcome Measures

Response Rate
Overall Response (OR) = CR + PR.
Median Survival
Toxicity
Number of participants with an adverse event. Please refer to the adverse event reporting for more detail.

Full Information

First Posted
April 5, 2005
Last Updated
June 3, 2014
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00107315
Brief Title
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

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to low accrual
Study Start Date
July 2004 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral capecitabine twice daily on days 1-7
Intervention Type
Biological
Intervention Name(s)
bevacizumab
Intervention Type
Drug
Intervention Name(s)
capecitabine
Primary Outcome Measure Information:
Title
Time to Progression
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Response Rate
Description
Overall Response (OR) = CR + PR.
Time Frame
1 year
Title
Median Survival
Time Frame
1 year
Title
Toxicity
Description
Number of participants with an adverse event. Please refer to the adverse event reporting for more detail.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwan Fakih, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

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

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