Study of the Antitumor Activity of Capecitabine in Combination With Erlotinib in Patients With Metastatic Colorectal Cancer

• Status: Terminated
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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, time to confirmed response rate, duration of confirmed response rate, time to treatment failure, and CEA response will be assessed.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peter Kozuch
• Collaborators: Genentech, Inc.; Hoffmann-La Roche
• Treatments: Capecitabine; Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.