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Phase II Study of Oxaliplatin, Capecitabine and Bevacizumab in the Treatment of Metastatic Colorectal Cancer

Phase 2
18 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

Phase II Study of Oxaliplatin, Capecitabine and Bevacizumab in the Treatment of Metastatic Colorectal Cancer



- Evaluate the response rate in patients with previously untreated metastatic colorectal
cancer treated with capecitabine, oxaliplatin, and bevacizumab.


- Assess time to progression (TTP), disease-free survival (DFS), and overall survival
(OS) in patients treated with this regimen.

- Assess the safety and tolerability of bevacizumab, oxaliplatin, and capecitabine in
patients with previously untreated metastatic colorectal cancer.


- Evaluate the effect of this regimen on the biomarkers of angiogenesis.

- Assess the effect of this regimen on wound angiogenesis.

OUTLINE: Patients receive oral capecitabine twice daily on days 1-5 and 8-12, oxaliplatin IV
over 2 hours on day 1, and bevacizumab IV over 1-1½ hours on day 1. Courses repeat every 14
days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Inclusion Criteria


- Histologically documented adenocarcinoma of the colon or rectum

- Metastatic or recurrent disease not amenable to potentially curative treatment
(e.g., inoperable metastatic disease)

- No leptomeningeal or brain metastases


- ECOG performance status 0-2

- Absolute neutrophil count ≥ 2,000/mm^3

- Platelet count ≥ 100,000/mm^3

- AST/ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if known liver

- Bilirubin < 1.5 times ULN

- Creatinine clearance > 50 mL/min

- No unstable or poorly controlled hypertension (> 150/100 mm Hg)

- Patients who have recently started or adjusted antihypertensive medications are
eligible provided blood pressure is < 140/90 mm Hg on any new regimen for at
least 3 different observations over 14 days

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during study and for at least 3-4
months after study completion

- No arterial or venous thrombosis (including cerebrovascular accident) within the last
3 months

- No known, existing, uncontrolled coagulopathy

- No clinically significant cardiac disease

- No congestive heart failure

- No symptomatic coronary artery disease

- No cardiac arrhythmias not well controlled with medication

- No myocardial infarction within the last 12 months

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to oxaliplatin, capecitabine, or bevacizumab

- No history of other disease, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or condition
that contraindicates the use of an investigational drug or that might affect the
interpretation of the results of the study or render the patient at high risk from
treatment complications


- At least 4 weeks since prior sorivudine or brivudine

- At least 6 months since prior adjuvant treatment with fluorouracil and leucovorin
calcium or a fluorouracil and leucovorin calcium-based regimen

- No major surgery within 4 weeks without complete recovery

- No prior chemotherapy for metastatic/recurrent disease

- No cancer immunotherapy or other biologic therapy while on therapy

- No radiotherapy while on study

- No hormonal therapy for cancer while on study

- No full-dose warfarin (INR of > 1.5), heparin (> 10,000 units/day), or thrombolytic

- Allopurinol and cimetidine should be discontinued prior to starting on this regimen

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate (Percentage of Participants With Partial or Complete Response)

Outcome Description:

Restaging scans occurred every 9 weeks from time of study drug initiation until disease progression. Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines. The definitions were: Complete response (CR)- Disappearance of all target lesions Partial response (PD)- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

Outcome Time Frame:

After all subjects were evaluated for restaging which occured every 9 weeks from drug initiation until disease progression, assesed up to 24 months.

Safety Issue:


Principal Investigator

Herbert I. Hurwitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

September 2003

Completion Date:

January 2016

Related Keywords:

  • Colorectal Cancer
  • adenocarcinoma of the colon
  • recurrent colon cancer
  • stage IV colon cancer
  • adenocarcinoma of the rectum
  • recurrent rectal cancer
  • stage IV rectal cancer
  • Colorectal Neoplasms