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)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
bevacizumab
cetuximab
FOLFIRI regimen
irinotecan
PRO95780
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring CRC, Colon cancer, Avastin, APM4187g
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Incidence and nature of dose-limiting toxicities
Secondary Outcome Measures
Incidence, nature, and severity of adverse events
Change in vital signs
Incidence and severity of infusion reactions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00497497
Brief Title
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)
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2007 (Actual)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
CRC, Colon cancer, Avastin, APM4187g
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Intervention Description
(Only for patients not previously treated with bevacizumab) Intravenous repeating dose
Intervention Type
Drug
Intervention Name(s)
cetuximab
Intervention Description
Intravenous repeating dose
Intervention Type
Drug
Intervention Name(s)
FOLFIRI regimen
Intervention Description
Intravenous repeating dose
Intervention Type
Drug
Intervention Name(s)
irinotecan
Intervention Description
Intravenous repeating dose
Intervention Type
Drug
Intervention Name(s)
PRO95780
Intervention Description
Intravenous repeating dose
Primary Outcome Measure Information:
Title
Incidence and nature of dose-limiting toxicities
Time Frame
Through study completion or early study discontinuation
Secondary Outcome Measure Information:
Title
Incidence, nature, and severity of adverse events
Time Frame
Through study completion or early study discontinuation
Title
Change in vital signs
Time Frame
Through study completion or early study discontinuation
Title
Incidence and severity of infusion reactions
Time Frame
Through study completion or early study discontinuation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon Bray, M.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
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)
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