A Study of PRO95780 in Combination With Cetuximab and Irinotecan Chemotherapy or the FOLFIRI Regimen With Bevacizumab in Patients With Previously Treated Metastatic Colorectal Cancer (APM4187g)

Colorectal Cancer Clinical Trial

Official title:

A Phase Ib, Dose-Escalation Study of the Safety and Pharmacokinetics of PRO95780 in Combination With Cetuximab and Irinotecan Chemotherapy or the FOLFIRI Regimen With Bevacizumab in Patients With Previously Treated Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00497497
• Other study ID #: APM4187g
• Status: Completed
• Phase: Phase 1
• First received: July 3, 2007
• Last updated: May 18, 2017
• Start date: October 2007
• Est. completion date: September 2010

Study information

• Verified date: May 2017
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase Ib, open-label, multicenter, dose-escalation study designed to assess if PRO95780 in combination with two different irinotecan-containing regimens is safe and tolerable in patients with metastatic colorectal cancer (mCRC) who have progressed following, or cannot tolerate, first-line therapy with 5-fluorouracil-, oxaliplatin-, and bevacizumab-containing regimens. This study will also make a preliminary assessment of the anti-tumor activity of PRO95780 in combination with irinotecan and cetuximab or the FOLFIRI regimen plus bevacizumab.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent

• Age = 18 years

• Histologically confirmed CRC with evidence of metastases and measurable tumor lesions

• Documented disease progression following, or intolerance to, treatment with 5-fluorouracil, oxaliplatin, and bevacizumab-based therapy

• Life expectancy > 3 months

• For patients of reproductive potential (males and females), use of reliable means for contraception (e.g., contraceptive pill, intrauterine device [IUD], physical barrier) 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:

• Patients who have a Kras mutation will be excluded from receiving cetuximab-containing regimens

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

• Recent radiotherapy to a peripheral lesion, thoracic, abdominal, or pelvic field

• Recent chemotherapy, hormonal therapy, or immunotherapy

• Evidence of clinically detectable ascites

• Other invasive malignancies within 5 years

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

• Current or recent participation in another experimental drug study

• Clinically significant cardiovascular disease

• Active infection requiring parenteral antibiotics

• Recent major surgical procedure, open biopsy, significant traumatic injury, fine needle aspirations, 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

• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or specified study treatment

• Pregnancy (positive pregnancy test) or breast feeding

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

• Known sensitivity to any of the products administered during the study

• Any disorder that compromises the ability of the patient to provide written informed consent and/or comply with study procedures

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• bevacizumab
(Only for patients not previously treated with bevacizumab) Intravenous repeating dose
• cetuximab
Intravenous repeating dose
• FOLFIRI regimen
Intravenous repeating dose
• irinotecan
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		Through study completion or early study discontinuation
Secondary	Incidence, nature, and severity of adverse events		Through study completion or early study discontinuation
Secondary	Change in vital signs		Through study completion or early study discontinuation
Secondary	Incidence and severity of infusion reactions		Through study completion or early study discontinuation