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


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

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Trial Information

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


OBJECTIVES:

Primary

- Determine the response rate in patients with unresectable metastatic or recurrent
colorectal adenocarcinoma treated with capecitabine, cetuximab, oxaliplatin, and
bevacizumab.

Secondary

- Determine the safety and tolerability of this regimen in these patients.

- Determine the progression-free and overall survival of patients treated with this
regimen.

Exploratory

- Determine the effect of this regimen on the angiogenesis biomarkers in these patients.

- Determine the effect of this regimen on wound angiogenesis in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral capecitabine twice daily on days 1-14. Patients will also receive
cetuximab IV over 1-2 hours, oxaliplatin IV over 2 hours, and bevacizumab IV over 30-90
minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed for 1 month.

PROJECTED ACCRUAL: Approximately 45 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the colon or rectum

- Unresectable disease

- Metastatic or recurrent disease

- Not amenable to potentially curative treatment

- No untreated leptomeningeal or brain metastases

PATIENT CHARACTERISTICS:

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

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

- Platelet count ≥ 100,000/mm^3

- No known uncontrolled coagulopathy

Hepatic

- AST and ALT < 2.5 times upper limits of normal (ULN) (5 times ULN if liver metastases
are present)

- Bilirubin < 2.0 times ULN

Renal

- Creatinine clearance > 40 mL/min

- Urine protein negative

- Urine protein:creatinine ratio > 1

Cardiovascular

- No unstable or uncontrolled hypertension (i.e., blood pressure [BP] > 150/100 mm Hg
despite antihypertensive therapy)

- Patients who recently started or have adjusted antihypertensive medications are
eligible provided BP is < 140/90 mm Hg for ≥ 3 different measurements over 14
days

- No arterial thromboembolic events within the past 6 months, including any of the
following:

- Transient ischemic attack

- Cerebrovascular accident

- Unstable angina

- Myocardial infarction

- Clinically significant peripheral vascular disease

- No New York Heart Association class III-IV congestive heart failure

- No uncontrolled symptomatic coronary artery disease or cardiac arrhythmia

- No other significant uncontrolled cardiac disease

Gastrointestinal

- No lack of physical integrity of the upper gastrointestinal tract

- No malabsorption syndrome

- No inability to tolerate oral medication

Immunologic

- No prior severe infusion reaction to a monoclonal antibody

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

- No prior unanticipated, severe reaction to fluoropyrimidine therapy or known
hypersensitivity to fluoroucacil

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during the study and for 3-4 months
after completion of study treatment

- No peripheral neuropathy ≥ grade 2

- No other malignancy within the past 5 years except adequately treated nonmelanoma
skin cancer or carcinoma in situ of the cervix

- No known dihydropyrimidine dehydrogenase deficiency

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior adjuvant bevacizumab or cetuximab

- No other concurrent anticancer immunotherapy or biologic therapy

Chemotherapy

- At least 6 months since a prior adjuvant fluorouracil-, leucovorin calcium-, or
capecitabine-based regimen

- At least 12 months since prior adjuvant oxaliplatin

- No prior chemotherapy for metastatic or recurrent disease

Endocrine therapy

- No concurrent hormonal therapy

Radiotherapy

- No concurrent radiotherapy

Surgery

- More than 4 weeks since prior major surgery and recovered

- More than 6 months since vascular surgery, stenting, or angioplasty

Other

- At least 4 weeks since prior and no concurrent sorivudine or brivudine

- More than 4 weeks since prior participation in any investigational drug study

- No prior therapy that affects or targets the epidermal growth factor pathway

- No concurrent cimetidine

- Concurrent ranitidine, famotidine, or proton-pump inhibitors allowed

- Concurrent anticoagulation therapy with full-dose anticoagulant allowed provided dose
is stable for at least 2 weeks

Type of Study:

Interventional

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:

No

Principal Investigator

Herbert I. Hurwitz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

Pro00007431 (CDR0000449945)

NCT ID:

NCT00290615

Start Date:

January 2006

Completion Date:

January 2011

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

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096