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

This study has been terminated.
(Terminated due to low accrual)
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00107315
First received: April 5, 2005
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Biological: bevacizumab
Drug: capecitabine
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Capecitabine and Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Time to Progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Overall Response (OR) = CR + PR.

  • Median Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    Number of participants with an adverse event.

    Please refer to the adverse event reporting for more detail.



Enrollment: 16
Study Start Date: July 2004
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral capecitabine twice daily on days 1-7
Biological: bevacizumab Drug: capecitabine

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

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107315

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Marwan Fakih, MD Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00107315     History of Changes
Other Study ID Numbers: I 22204, RPCI-I-22204, GENENTECH-RPCI-I-22204
Study First Received: April 5, 2005
Results First Received: January 8, 2014
Last Updated: June 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
recurrent colon cancer
stage IV colon cancer
recurrent rectal cancer
stage IV rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Fluorouracil
Bevacizumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014