Status:
TERMINATED
Study of the Antitumor Activity of Capecitabine in Combination With Erlotinib in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Peter Kozuch
Collaborating Sponsors:
Hoffmann-La Roche
Genentech, Inc.
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To document the antitumor activity of capecitabine in combination with erlotinib in patients with previously untreated metastatic colorectal cancer. Time to tumor progression, objective response rate,...
Detailed Description
Approximately 150,000 people are diagnosed with colorectal cancer in the United States each year. Forty to fifty thousand people eventually will develop metastatic colorectal cancer and 40,000 people ...
Eligibility Criteria
Inclusion
- Patients who have histologically or cytologically confirmed diagnosis of metastatic colorectal adenocarcinoma.
- Patients must be \> 18 years old.
- Patients must have a performance status of \> 60 on the Karnofsky scale
- Patients must have an expected life expectancy of at least 12 weeks.
- Patients must give written informed consent as per institutional and federal regulatory requirements.
- Patients must have measurable or evaluable disease .
- Patients must have an absolute neutrophil count of \> 1,500/mm3 and a platelet count \> 100,000/mm3.
- Patients must have adequate liver and renal function defined by a bilirubin of \< 2.0 mg/dl and a creatinine of \< 1.5 mg/dl, respectively.
- Patients must be able to stay in the general area for the duration of their treatment on this clinical research study.
Exclusion
- Prior chemotherapy, treatment with inhibitors of EGFR of any kind, molecularly targeted
- Pregnant or lactating women
- Clinical signs of brain involvement or leptomeningeal disease
- Serious illness or medical conditions
- Congestive heart failure or unstable angina pectoris, uncontrolled hypertension or arrhythmias
- Active infections
- UnstaOphthalmic disorders that might increase the risk for epithelium related complications (bullous keratopathy, aniridia, severe chemical burns, neutrophilic keratitis e.g.)
- GI tract disease resulting in an inability to take oral medication such as uncontrolled inflammatory GI disease (e.g. Crohn's disease, ulcerative colitis) or post surgical malabsorption characterized by uncontrolled diarrhea that results in weight loss and vitamin deficiency orequires IV hyperalimentation (however, use of pancreatic enzyme supplementation is allowed provided that the above criteria are not met).
- Prior invasive malignancies for less 5 years
- Known to be HIV positive.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00459901
Start Date
June 1 2004
End Date
June 1 2005
Last Update
April 29 2015
Active Locations (1)
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1
Beth Israel Medical Center
New York, New York, United States, 10003