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)
This study has been completed.
Sponsor:
Genentech
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00497497
First received: July 3, 2007
Last updated: February 15, 2011
Last verified: February 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: bevacizumab Drug: cetuximab Drug: FOLFIRI regimen Drug: irinotecan Drug: PRO95780 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- Incidence and nature of dose-limiting toxicities [ Time Frame: Through study completion or early study discontinuation ]
Secondary Outcome Measures:
- Incidence, nature, and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ]
- Change in vital signs [ Time Frame: Through study completion or early study discontinuation ]
- Incidence and severity of infusion reactions [ Time Frame: Through study completion or early study discontinuation ]
| Enrollment: | 20 |
| Study Start Date: | October 2007 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: cetuximab
Intravenous repeating dose
Drug: irinotecan
Intravenous repeating dose
Drug: PRO95780
Intravenous repeating dose
|
| Experimental: 2 |
Drug: bevacizumab
(Only for patients not previously treated with bevacizumab) Intravenous repeating dose
Drug: FOLFIRI regimen
Intravenous repeating dose
Drug: PRO95780
Intravenous repeating dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Clinical Trials Posting Group, Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT00497497 History of Changes |
| Other Study ID Numbers: | APM4187g |
| Study First Received: | July 3, 2007 |
| Last Updated: | February 15, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Genentech:
|
CRC Colon cancer Avastin APM4187g |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Irinotecan Bevacizumab Cetuximab |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013