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

Arm | Intervention/treatment |
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Experimental: bevacizumab before chemotherapy
Bevacizumab administered 4 days before each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)
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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)
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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) |
- number of objective responses [ Time Frame: 6 months ]
- progression free survival [ Time Frame: one year ]
- overall survival [ Time Frame: 30 months ]
- worst grade toxicity per patient [ Time Frame: evaluated every 2 weeks up to 6 months ]
- changes in quality of life [ Time Frame: measured at baseline, 12 weeks, and 24 weeks ]
- 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
- change in metabolic tumor volume [ Time Frame: 11 days from first day of first cycle of chemotherapy ]measured by PET scan

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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 |
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

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
Italy | |
Istituto Nazionale Tumori Fondazione G. Pascale | |
Napoli, Italy |
Principal Investigator: | Antonio Avallone, M.D. | National Cancer Institute, Naples |
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 |
metastatic stage IV |
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 |