A Study of EZN-2208 Administered With or Without Cetuximab in Patients With Metastatic Colorectal Carcinoma
| Status: | Archived |
|---|---|
| Conditions: | Colorectal Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | June 2009 |
| End Date: | May 2011 |
A Phase 2 Study of EZN-2208 (PEG-SN38) Administered With or Without Cetuximab in Patients With Metastatic Colorectal Carcinoma (mCRC)
This is a Phase 2, multicenter, multiple-arm, open-label study to evaluate the efficacy,
safety, and tolerability of EZN-2208. EZN-2208 will be administered as a single agent in
patients with K-RAS mutations in the tumors. Patients with wild type K-RAS in tumors will be
randomized to EZN-2208 + cetuximab or to standard of care (Camptosar® + cetuximab), patients
must have failed regimens containing irinotecan (Camptosar®, CPT-11), oxaliplatin
(Eloxatin®), and fluoropyrimidine.
After discontinuation of study treatment, patients will receive care as considered
appropriate by the investigator. Patients will continue to be followed for disease
progression, subsequent anticancer therapy, and survival.
EZN-2208 will be administered by i.v. infusion weekly for 3 weeks in 4-week cycles. The
cetuximab infusion will be administered before the EZN-2208 (Arm B) or irinotecan (Arm C)
infusion. Study treatment will be continued until evidence of disease progression,
unacceptable toxicity, or withdrawal of the patient's consent for participation in the
study.
Approximately 220 patients will be enrolled in this study: approximately 100 patients in the
K-RAS mutated arm and approximately 120 patients in the wild-type K-RAS arm.
We found this trial at
45
sites
1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
Port Saint Lucie, Florida 34952
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Roswell Park Cancer Center Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer...
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Umass Memorial Medical Center UMass Memorial Medical Center is the region's trusted academic medical center,...
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