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

This study has been completed.
Sponsor:
Collaborators:
Hoffmann-La Roche
Genentech, Inc.
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT00159432
First received: September 7, 2005
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

This study is for people with colorectal cancer, who have tumors that cannot be completely removed by surgery. This study is being done to find out how long it takes tumors to grow after patients receive the drugs capecitabine, oxaliplatin and bevacizumab. Capecitabine (also called Xeloda) is a drug that has been approved by the FDA for treatment of advanced colorectal cancer. Capecitabine prevents some colorectal cancer cancer cells from reproducing, and causes some of them to die. Oxaliplatin (also called Eloxatin) has also been approved by the FDA for treatment of advanced colorectal cancer. Oxaliplatin prevents some colorectal cancer cells from reproducing. Bevacizumab is an investigational drug. Bevacizumab is an antibody (a protein that acts against a specific substance) directed against vascular endothelial growth factor (VEGF). VEGF promotes the growth of blood vessels that bring nutrients to cells. Bevacizumab inhibits the growth of colon cancer cells, by blocking the effects of VEGF. The combination of the drugs used in this study is experimental. The purpose of this study is to see how long it takes patients' tumors to grow when they are taking this combination of drugs.


Condition Intervention Phase
Colorectal Cancer
Drug: Oxaliplatin
Drug: Bevacizumab
Drug: Capecitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Oxaliplatin, Capecitabine and Bevacizumab as First Line Treatment for Patients With Advanced Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Median Time for Progression Free Survival [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
    Progression-free survival was measured from the start of treatment until the time the subject is first recorded as having disease progression (progression = 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in the opinion of treating physician, appearance of new lesion/site, death due to disease), or death due to any cause. If a subject has not progressed or died, progression-free survival was censored at the time of last follow-up or the start of another treatment, whichever came first.


Secondary Outcome Measures:
  • Number of Participants With Grade 3 or Higher Toxicity [ Time Frame: Baseline, every 2 weeks of each cycle, and at end of treatment, up to 18 months. ] [ Designated as safety issue: Yes ]
    Summary of grade 3 (per CTCAE v3.0) or higher toxicities which generally is described as a severe adverse reaction or symptom.


Enrollment: 63
Study Start Date: February 2005
Study Completion Date: March 2013
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxaliplatin, followed by Bevacizumab with Capecitabine
oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
Drug: Oxaliplatin
Other Name: Eloxatin
Drug: Bevacizumab
Other Name: Avastin
Drug: Capecitabine
Other Name: Xeloda

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 fibrosis.
  • History of persistent neurosensory disorder including but not limited to peripheral neuropathy.
  • 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 study.
  • Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
  • 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 disease)
  • 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 treatment.
  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: NCT00159432

Locations
United States, California
U.S.C./Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Hoffmann-La Roche
Genentech, Inc.
Investigators
Principal Investigator: Syma Iqbal, M.D. U.S.C. Norris Comprehensive Cancer Center
  More Information

No publications provided by University of Southern California

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00159432     History of Changes
Other Study ID Numbers: 3C-04-10
Study First Received: September 7, 2005
Results First Received: November 27, 2013
Last Updated: July 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Southern California:
colorectal
cancer

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

ClinicalTrials.gov processed this record on November 25, 2014