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)

Sponsor

Genentech, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00851136

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Metastatic Colorectal Cancer	Drug: bevacizumab Drug: FOLFOX Drug: PRO95780	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

May 1, 2009

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: bevacizumab Intravenous repeating dose Drug: FOLFOX Intravenous repeating dose Drug: PRO95780 Intravenous repeating dose

Arm

Intervention/Treatment

Experimental: 1

Drug: bevacizumab

Intravenous repeating dose

Drug: FOLFOX

Intravenous repeating dose

Drug: PRO95780

Intravenous repeating dose

Outcome Measures

Primary Outcome Measures

Incidence and nature of dose-limiting toxicities [Length and study]

Secondary Outcome Measures

Incidence, nature, and severity of adverse events [Length of study]
Change in vital signs [Length of study]
Incidence and severity of infusion reactions [Length of study]
Change in clinical laboratory results [Length of study]
Incidence of anti-PRO95780 antibodies [Length of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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