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Phase II Study of Oxaliplatin, Capecitabine and Bevacizumab as First Line Treatment for Patients With Advanced Colorectal Cancer

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

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Trial Information

Phase II Study of Oxaliplatin, Capecitabine and Bevacizumab as First Line Treatment for Patients With Advanced Colorectal Cancer

Inclusion Criteria:

- Histologically or cytologically confirmed metastatic or recurrent colorectal tumors
with no previous treatment for advanced disease.

- Age greater than or equal to 18 years

- SWOG performance status 0-1.

- At least one measurable lesion according to the RECIST criteria which has not been
irradiated (i.e. newly arising lesions in previously irradiated areas are accepted).
Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by
conventional techniques.

- Have a negative serum pregnancy test within 7 days prior to initiation of
chemotherapy (female patients of childbearing potential).

- Availability of tumor biopsy (paraffin embedded or fresh frozen) at the time of
diagnosis and/or prior to study entry is required.

- Patients must agree to have a 20 cc blood sample drawn in addition to routine labs
with each cycle of chemotherapy.

Exclusion Criteria:

- Pregnant or lactating woman.

- Life expectancy < 3 months.

- Serious, uncontrolled, concurrent infection(s) or illness(es)

- Any prior oxaliplatin treatment, with the exception of adjuvant therapy given > 12
months prior to the beginning of study therapy

- Prior unanticipated severe reaction to fluoropyrimidine therapy, known
hypersensitivity to 5-fluorouracil, or known DPD deficiency

- Prior unanticipated severe reaction or hypersensitivity to platinum based compounds.

- Treatment for other carcinomas within the last five years, except cured non-melanoma
skin and treated in-situ cervical cancer.

- Current, recent (within 4 weeks of first infusion on this study) or planned
participation in an investigational drug study.

- Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic
coronary artery disease and cardiac arrhythmias not well controlled with medication)
within the last 6 months.

- History of clinically significant interstitial lung disease and/or pulmonary

- History of persistent neurosensory disorder including but not limited to peripheral

- Presence of central nervous system or brain mets.

- Major surgery, open biopsy, or significant traumatic injury within 28 days prior to
Day 0, or anticipation of need for major surgical procedure during the course of the

- Lack of physical integrity of the upper gastrointestinal tract or malabsorption

- Any of the following laboratory values:

- Abnormal hematologic values (neutrophils < 1.5 x 109/L, platelet count <
100 x 109/L)

- Urine protein: creatinine ratio >/= 1.0 Impaired renal function with estimated
creatinine clearance < 30 ml/min as calculated with Cockroft et Gault equation:

- Serum bilirubin > 1.5 x upper normal limit. ALT, AST > 2.5 x upper normal limit
(or > 5 x upper normal limit in the case of liver metastases)

- Alkaline phosphatase > 2.5 x upper normal limit (or > 5 x upper normal limit in
the case of liver metastases or > 10 x upper normal limit in the case of bone

- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days
prior to Day 0

- Blood pressure > 150/100 mmHg

- Unstable angina

- New York Heart Association (NYHA) Grade II or greater congestive heart failure

- History of myocardial infarction or stroke within 6 months

- Clinically significant peripheral vascular disease

- Evidence of bleeding diathesis or coagulopathy

- History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess
within 28 days prior to Day 0.

- Serious, non-healing wound, ulcer or bone fracture

- Carcinoma of any histology in close proximity to a major vessel, cavitation or
history of hemoptysis.

- Completion of previous adjuvant chemotherapy regimen < four weeks prior to the start
of study treatment (within six weeks of study treatment for mitomycin C and
nitroureas), or with related toxicities unresolved prior to the start of study

Type of Study:


Study Design:

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

Outcome Measure:

To determine the median time for progression free survival in patients with advanced colorectal cancer treated with a combination of capecitabine, oxaliplatin and bevacizumab.

Outcome Time Frame:

every 2 cycles

Safety Issue:


Principal Investigator

Syma Iqbal, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

U.S.C. Norris Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2005

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • colorectal
  • cancer
  • Colorectal Neoplasms



U.S.C./Norris Comprehensive Cancer Center Los Angeles, California  90033