Status:
COMPLETED
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)
Lead Sponsor:
Genentech, Inc.
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This will be a multicenter, open-label study enrolling a total of up to 23 patients.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00851136
Start Date
May 1 2009
End Date
June 1 2010
Last Update
December 13 2022
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