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Phase 2 N=30 Treatment

Capecitabine, Cetuximab, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer That Cannot Be Removed By Surgery

Colorectal Cancer

Enrolled (actual)
30
Serious AEs
33.3%
Results posted
May 2013
Primary outcome: Primary: Response Rate (Percentage of Participants With Partial or Complete Response) — 43 percentage of participants with response

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
bevacizumab (Biological); cetuximab (Biological); capecitabine (Drug); oxaliplatin (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Herbert Hurwitz
Primary completion
Jan 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Response Rate (Percentage of Participants With Partial or Complete Response)
43
SECONDARY
Safety and Tolerability
30
SECONDARY
Progression-free Survival
10.3
SECONDARY
Overall Survival
18.8

Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as cetuximab and 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. Cetuximab and bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving capecitabine together with cetuximab, oxaliplatin, and bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving capecitabine together with cetuximab, oxaliplatin, and bevacizumab works in treating patients with metastatic or recurrent colorectal cancer that cannot be removed by surgery.

Eligibility 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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00290615). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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