A Study of PRO95780 Administered in Combination With the FOLFOX Regimen and Bevacizumab in Patients With Previously Untreated, Locally Advanced, Recurrent, and Metastatic Colorectal Cancer (APM4566g)

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This will be a multicenter, open-label study enrolling a total of up to 23 patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• Histologically confirmed CRC with evidence of locally advanced recurrent or metastatic disease and measurable tumor lesions

• Life expectancy > 3 months

• For patients of reproductive potential (males and females), use of reliable means for contraception throughout the trial and for 6 months following their final exposure to study treatment

• Willingness and capability to be accessible for study follow-up

Exclusion Criteria:

• Prior 5-FU, capecitabine, and/or oxaliplatin treatment with the exception of: prior oxaliplatin treatment≤ 6 weeks in the advanced or metastatic setting; prior treatment with 5-FU, capecitabine, and/or oxaliplatin in the adjuvant setting if relapse occurred > 6 months from concluding adjuvant therapy

• Peripheral neuropathy Grade ≥ 2

• Prior radiotherapy to a measurable metastatic lesion(s) to be used for response assessment, unless the lesion has progressed subsequent to the radiotherapy

• Radiotherapy to a peripheral lesion within 14 days prior to Cycle 1, Day 1, or radiotherapy to a thoracic, abdominal, or pelvic field within 28 days prior to Cycle 1, Day 1

• Chemotherapy, hormonal therapy, or immunotherapy within 4 weeks prior to Cycle 1, Day 1

• Evidence of clinically detectable ascites

• Other invasive malignancies within 5 years prior to Cycle 1, Day 1

• History or evidence upon physical examination of active central nervous system (CNS) disease

• Current or recent participation in another experimental drug study

• Clinically significant cardiovascular disease, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia within 1 year prior to Cycle 1, Day 1, or Grade II or greater peripheral vascular disease

• Active infection requiring parenteral antibiotics

• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Cycle 1, Day 1, fine needle aspirations within 7 days prior to Cycle 1, Day 1, or anticipation of need for major surgical procedure during the course of the study

• Known or suspected to be positive for the human immunodeficiency virus (HIV)

• Known to be positive for hepatitis C or hepatitis B surface antigen

• Inadequately controlled hypertension

• Prior history of hypertensive crisis or hypertensive encephalopathy

• History of arterial thromboembolic event 6 months prior to Cycle 1, Day 1

• History of abdominal fistula or gastrointestinal perforation within 6 months prior to Cycle 1, Day 1

• Bleeding diathesis or coagulopathy

• Pregnancy (positive pregnancy test) or breast feeding

• Serious, non-healing wound, ulcer, or bone fracture