A single-arm, open-label phase II study: Treatment beyond progression by adding Bevacizumab to XELOX or FOLFOX chemotherapy in patients with metastatic colorectal cancer and disease progression, under first-line FOLFIRI + bevacizumab combination - AVASTAY

.V. Roche S.A.0 sites100 target enrollmentJune 25, 2009

ConditionsMetastatic colorectal cancer with disease progression under first-line FOLFIRI + Bevacizumab combination (Patients no candidates for primary metastectomy)MedDRA version: 14.1Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

DrugsAvastin 25 mg/ml concentrate for solution for infusion

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Metastatic colorectal cancer with disease progression under first-line FOLFIRI + Bevacizumab combination (Patients no candidates for primary metastectomy)
Sponsor: .V. Roche S.A.
Enrollment: 100
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 25, 2009

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

.V. Roche S.A.

Eligibility Criteria

Inclusion Criteria

•\- Patients with histological onfirmed diagnosis of metastatic CRC and disease progression (according to RECIST assessed by investigator, documented by CT or MRI) previously treated with first\-line therapy (FOLFIRI \+ Bevacizumab) until progression and who are no candidates for primary metastectomy.
•\- At least one measurable lesion according to RECIST version 1\.1
•\- Disease Progression \= 8 weeks after last bevacizumab administration.
•\- No more than 8 weeks between last administration 1st line treatment with FOLFIRI \+ bevacizumab and start 2nd line XELOX or FOLFOX \+ Bevacizumab
•\- Evaluation of tumor disease according to RECIST by investigator, 4 weeks or less prior inclusion.
•\- No major surgery within 4 weeks prior to inclusion
•\- Wound healing completed
•\- Age \= 18 years
•\- Life expectancy \> 3 months
•\- ECOG \= 2

Exclusion Criteria

•\- Diagnosis of progression of disease more than 8 weeks after last Bevacizumab administration
•\- Current and/or previous treatment with any other investigational agent or other biological agent (e.g. cetuximab)
•\- Participation in another clinical trial (except for the non\-interventiolal trial ML22517 \- Avastart) within 30 days prior to entering this study
•\- Inadequately controlled hypertension (definded as systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg)
•\- Prior history of hypertensive crisis or hypertensive encephalopathy
•\- NYHA Class II or greater CHF
•\- History of myocardial infarction or unstable angina within 6 months prior to Day 1
•\- Known CNS disease, except for treated brain metastasis (treated brain metastasis are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvultants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radio surgery (RS; Gamma Knife; LINAC; or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months of start of study therapy will be excluded).
•\- Significant vascular disease (e.g. aortic aneurysm requiring surgical intervention, pulmonary embolism or recent peripheral arterial thrombosis) within 6 months prior start of study treatment.
•\- History of haemoptysis (\= ½ teaspoon of bright red blood per episode) within 1 month prior to start of study treatment