Clinical trial NCT00388206: A Study of Avastin in Combination With Chemotherapy for Treatment of Colorectal Cancer and Non-Small Cell Lung Cancer (ARIES)
Official title: An Observational Study of Avastin (Bevacizumab) in Combination With Chemotherapy for Treatment of Metastatic or Locally Advanced and Unresectable Colorectal Cancer and Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Excluding Predominant Squamous Cell Histology)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Non-Small Cell Lung Cancer
Keywords: NSCLC
Avastin
anti-VEGF
lung cancer
colorectal cancer
ARIES
Colon Cancer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2006-10-16
Enrollment: 3998
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: This is an observational study designed to follow patients with metastatic or locally advanced and unresectable CRC or locally advanced or metastatic NSCLC (excluding predominant squamous histology) who are receiving Avastin in combination with first-line chemotherapy. Second-line metastatic CRC patients are also eligible. Patients who started their Avastin containing therapy \<4 months prior to enrollment are eligible.


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent Form
* Metastatic or locally advanced and unresectable CRC or locally advanced or metastatic NSCLC (excluding predominant squamous histology)
* Eligible for Avastin as a component of intended therapy
* First-line chemotherapy (or second-line chemotherapy for CRC) plus Avastin initiated ≤ 4 months prior to study enrollment

Exclusion Criteria:

* Any medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to provide informed consent or comply with the treatment and follow-up, as specified by the investigator
* Enrollment in a blinded, placebo-controlled bevacizumab trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Wozniak AJ, Kosty MP, Jahanzeb M, Brahmer JR, Spigel DR, Leon L, Fish S, Flick ED, Hazard SJ, Lynch TJ Jr. Clinical outcomes in elderly patients with advanced non-small cell lung cancer: results from ARIES, a bevacizumab observational cohort study. Clin Oncol (R Coll Radiol). 2015 Apr;27(4):187-96. doi: 10.1016/j.clon.2014.12.002. Epub 2015 Jan 7.
citation: Douillard JY, Ostoros G, Cobo M, Ciuleanu T, Cole R, McWalter G, Walker J, Dearden S, Webster A, Milenkova T, McCormack R. Gefitinib treatment in EGFR mutated caucasian NSCLC: circulating-free tumor DNA as a surrogate for determination of EGFR status. J Thorac Oncol. 2014 Sep;9(9):1345-53. doi: 10.1097/JTO.0000000000000263.
citation: Lynch TJ Jr, Spigel DR, Brahmer J, Fischbach N, Garst J, Jahanzeb M, Kumar P, Vidaver RM, Wozniak AJ, Fish S, Flick ED, Leon L, Hazard SJ, Kosty MP; ARIES Study Investigators. Safety and effectiveness of bevacizumab-containing treatment for non-small-cell lung cancer: final results of the ARIES observational cohort study. J Thorac Oncol. 2014 Sep;9(9):1332-9. doi: 10.1097/JTO.0000000000000257.