EUCTR2016-001508-45-ES
Active, not recruiting
Phase 1
Phase II clinical trial to evaluate the efficacy of FOLFIRI + aflibercept in patients with metastatic colorectal cancer previously treated with oxaliplatin with or without ACE polymorphisms - POLAF
Grupo de Tratamiento de los Tumores Digestivos (TTD)0 sites100 target enrollmentJuly 15, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Metastatic colorectal cancer
- Sponsor
- Grupo de Tratamiento de los Tumores Digestivos (TTD)
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Informed consent form signed and dated, and willingness and ability to accomplish the protocol requirements.
- •2\. Histologically confirmed Adenocarcinoma of the colon and / or rectum
- •3\. Diagnosed metastatic disease.
- •4\. Evidence of at least one measurable lesion using one\-dimensional CT or MRI according to RECIST criteria, version 1\.1\.
- •5\. Patients with metastatic colorectal cancer (MCRC) that is resistant or has progressed after treatment with oxaliplatin.
- •6\. Age \= 18 years.
- •7\. Functional status (EF) of the World Health Organization (WHO) of 0 to 2\.
- •8\. Adequate bone marrow function: neutrophils (ANC) \= 1\.5 x 109 / l; platelets \= 100 x
- •109 / l; hemoglobin \= 9 g / dl.
- •9\. Adequate renal function: serum creatinine level \<1\.5 times the upper limit of normal (ULN).
Exclusion Criteria
- •1\. Uncontrolled hypercalcemia.
- •2\. Pre\-existing permanent Neuropathy (NCI grade\> 2\).
- •3\. Uncontrolled hypertension (defined as systolic blood pressure \> 150 mm Hg and / or diastolic blood pressure\> 100 mm Hg) or history of hypertensive crisis or hypertensive encephalopathy.
- •4\. Concomitant antineoplastic treatment non\-scheduled in the protocol (e.g., chemotherapy, targeted molecular therapy, immunotherapy).
- •5\. Treatment with any other investigational product within 28 days prior to inclusion in the study.
- •6\. Another serious and uncontrolled non\-malignant disease
- •7\. History or evidence of CNS metastases on physical examination, unless it is properly treated (e.g., non\-irradiated CNS metastases, convulsion uncontrolled with standard medical treatment).
- •8\. Diagnosis of Gilbert's syndrome.
- •9\. Atropine sulfate or loperamide intolerance.
- •10\. Diagnosis of dihydropyrimidine dehydrogenase deficiency.
Outcomes
Primary Outcomes
Not specified
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