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Optimization of Bevacizumab Scheduling With Chemotherapy for Metastatic Colorectal Cancer (OBELICS)

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ClinicalTrials.gov Identifier: NCT01718873
Recruitment Status : Unknown
Verified March 2017 by National Cancer Institute, Naples.
Recruitment status was:  Active, not recruiting
First Posted : October 31, 2012
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples

Study Description
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Brief Summary:
The purpose of this study is to evaluate if giving bevacizumab prior to chemotherapy compared to giving bevacizumab at the same time as chemotherapy improves patient overall response to treatment.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Bevacizumab Drug: Oxaliplatin Drug: levo-folinic acid Drug: 5-fluorouracil Drug: Capecitabine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase 3 Study on the Optimization of Bevacizumab With mFOLFOX/mOXXEL in the Treatment of Patients With Metastatic Colorectal Cancer
Study Start Date : May 2012
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: bevacizumab before chemotherapy
Bevacizumab administered 4 days before each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)
 Drug: Bevacizumab
5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.
Other Name: Avastin

Drug: Oxaliplatin
85mg/m2 IV every 2 weeks for up to 24 weeks

Drug: levo-folinic acid
200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks

Drug: 5-fluorouracil
400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)

Drug: Capecitabine
1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)
Active Comparator: bevacizumab with chemotherapy
Bevacizumab administered on the first day of each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)
 Drug: Bevacizumab
5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.
Other Name: Avastin

Drug: Oxaliplatin
85mg/m2 IV every 2 weeks for up to 24 weeks

Drug: levo-folinic acid
200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks

Drug: 5-fluorouracil
400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)

Drug: Capecitabine
1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)


Outcome Measures
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Primary Outcome Measures :
  1. number of objective responses [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. progression free survival [ Time Frame: one year ]
  2. overall survival [ Time Frame: 30 months ]
  3. worst grade toxicity per patient [ Time Frame: evaluated every 2 weeks up to 6 months ]
  4. changes in quality of life [ Time Frame: measured at baseline, 12 weeks, and 24 weeks ]

Other Outcome Measures:
  1. evaluation of prognostic and predictive factors [ Time Frame: 1 year ]
    circulating endothelial cell counts, cytokines, antiangiogenic factors, single nucleotide polymorphisms of VEGF, leukocyte count 24 hours after administration of bevacizumab, and mRNA will be evaluated in blood samples of participating consenting patients, for correlation with clinical outcomes of patients

  2. change in metabolic tumor volume [ Time Frame: 11 days from first day of first cycle of chemotherapy ]
    measured by PET scan


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological diagnosis of colorectal adenoma carcinoma
  • Stage IV disease
  • Presence of at least one measurable target lesion (according to RECIST), and not previously radiated.
  • Age ≥ 18 e ≤ 75 years
  • ECOG Performance status 0-1
  • Life expectancy >3 months
  • Adequate recovery from surgery, with at least 28 days from surgery to date of pre-study biopsy.
  • Adequate contraception for male and female patients of child bearing potential
  • informed consent

Exclusion Criteria:

  • More than one previous line of therapy for metastatic disease
  • Prior treatment with bevacizumab or oxaliplatin (previous treatment with irinotecan,, cetuximab, fluoropyrimidine, folic acid are permitted)
  • Primary tumor that is stenosing and/or that infiltrates the entire thickness of the intestinal wall
  • Regular use of NSAIDs or aspirin
  • Bleeding disorders or coagulopathy
  • Concurrent anticoagulant therapy
  • Suspected or cerebral metastases (to verify in the presence of symptoms)
  • Neutrophils < 2000 / mm3, platelets < 100,000 / mm3, hemoglobin < 9g/dl
  • Creatinine > 1.5 times the upper normal limit
  • GOT and/or GPT > 2.5 times the upper normal limit, bilirubin > 1.5 times the upper normal limit in absence of liver metastases
  • GOT and/or GPT > 5 times the upper normal limit, bilirubin > 3 times the upper normal limit in presence of liver metastases
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal and squamous cell carcinoma or cervical cancer in situ
  • Congestive heart failure, ischemic coronary events within past 12 months, uncontrolled cardiac arrhythmia
  • Uncontrolled hypertension
  • Active or uncontrolled infection
  • Any concomitant condition that, in the investigator's opinion, would contraindicate the use of any of the study drugs
  • Pregnancy or lactation
  • Central nervous system disorders or peripheral neuropathy > grade 1 (CTCAE v. 4.0)
  • Inability to comply with follow up procedures of the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718873


Locations
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Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
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Principal Investigator: Antonio Avallone, M.D. National Cancer Institute, Naples
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT01718873    
Other Study ID Numbers: OBELICS
2011-004997-27 ( EudraCT Number )
First Posted: October 31, 2012    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Keywords provided by National Cancer Institute, Naples:
metastatic
stage IV
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Folic Acid
Bevacizumab
Fluorouracil
 Capecitabine
Oxaliplatin
Levoleucovorin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors