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Randomized Phase 3 Study on the Optimization of Bevacizumab With mFOLFOX/mOXXEL in the Treatment of Patients With Metastatic Colorectal Cancer


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

Randomized Phase 3 Study on the Optimization of Bevacizumab With mFOLFOX/mOXXEL in the Treatment of Patients With Metastatic Colorectal Cancer


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

number of objective responses

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Antonio Avallone, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute, Naples

Authority:

Italy: Ethics Committee

Study ID:

OBELICS

NCT ID:

NCT01718873

Start Date:

May 2012

Completion Date:

August 2015

Related Keywords:

  • Colorectal Cancer
  • metastatic
  • stage IV
  • Colorectal Neoplasms

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