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)

Metastatic Colorectal Cancer Clinical Trial

Official title:

A Phase Ib Study of the Safety and Pharmacokinetics of PRO95780 Administered in Combination With the FOLFOX Regimen and Bevacizumab in Patients With Previously Untreated, Locally Advanced, Recurrent, and Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00851136
• Other study ID #: APM4566g
• Status: Completed
• Phase: Phase 1
• Start date: May 2009
• Est. completion date: June 2010

Study information

• Verified date: December 2022
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• bevacizumab
Intravenous repeating dose
• FOLFOX
Intravenous repeating dose
• PRO95780
Intravenous repeating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and nature of dose-limiting toxicities		Length and study
Secondary	Incidence, nature, and severity of adverse events		Length of study
Secondary	Change in vital signs		Length of study
Secondary	Incidence and severity of infusion reactions		Length of study
Secondary	Change in clinical laboratory results		Length of study
Secondary	Incidence of anti-PRO95780 antibodies		Length of study