A Study of Avastin (Bevacizumab) With XELOX or FOLFOX in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line FOLFIRI and Avastin

Roche

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: leucovorin; Drug: oxaliplatin; Drug: bevacizumab [Avastin]; Drug: capecitabine [Xeloda]; Drug: fluorouracil (5FU)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01077739

2009-012090-36

ML22519

Details and patient eligibility

About

This open-label single arm study will evaluate the efficacy and safety of Avastin added to XELOX or FOLFOX in patients with metastatic colorectal cancer and disease progression on 1st line therapy with FOLFIRI plus Avastin. Patients will receive either Avastin (7.5mg/kg iv infusion every 3 weeks) and standard XELOX (Xeloda [capecitabine] plus oxaliplatin) chemotherapy or Avastin (5 mg/kg iv infusion every 2 weeks) and standard FOLFOX (5-FU and leucovorin plus oxaliplatin) chemotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients >/=18 years of age
• metastatic colorectal cancer
• at least 1 measurable lesion according to RECIST v. 1.1
• patients with disease progression with prior FOLFIRI + Avastin therapy who are not candidates for primary metastasectomy
• disease progression </= 8 weeks after last dose of Avastin
• ECOG </=2
• No more than 8 weeks between 1st-line treatment with FOLFIRI + Avastin and 2nd-line treatment with XELOX or FOLFOX + Avastin

Exclusion criteria

• disease progression > 8 weeks after last Avastin administration
• clinically significant cardiovascular disease
• CNS disease except for treated brain metastasis
• history of other malignancies within 2 years prior to start of study treatment (with the exception of curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix)
• major surgery, open biopsy, or significant traumatic injury within 28 days prior to start of study treatment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Avastin (bevacizumab) + standard of care

Experimental group

Treatment:

Drug: fluorouracil (5FU)

Drug: capecitabine [Xeloda]

Drug: oxaliplatin

Drug: bevacizumab [Avastin]

Drug: leucovorin