Cetuximab and Capecitabine in Treating Patients With Metastatic Colorectal Cancer That Failed Irinotecan Treatment

Phase 2

Terminated

• Conditions: Colorectal Cancer
• Interventions: Biological: cetuximab; Drug: capecitabine; Genetic: gene expression analysis; Genetic: microarray analysis; Genetic: polymorphism analysis; Genetic: reverse transcriptase-polymerase chain reaction; Other: immunohistochemistry staining method

• Registration Number: NCT00538291
• Lead Sponsor: City of Hope Medical Center

Brief Summary

RATIONALE: Monoclonal antibodies such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with capecitabine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with capecitabine work in treating patients with metastatic colorectal cancer.

Detailed Description

OBJECTIVES:

Primary

* Determine the response rate in patients with metastatic colorectal cancer treated with cetuximab and capecitabine that progressed on prior fluoropyrimidine-containing therapy comprising irinotecan with or without oxaliplatin.

Secondary

* To determine the progression-free survival and overall survival of patients treated with this regimen.

* To determine the tolerance to therapy in these patients.

* To assess biological correlates of response in available tissue biopsies and blood samples.

OUTLINE: Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood collection periodically for correlative studies. Samples are analyzed for expression of genes correlated with fluoropyrimidine responsiveness via quantitation RT-PCR; degree of expression of EGFR via immunohistochemistry; and expression pattern analysis via gene expression profiling and polymorphism.

After completion of study treatment, patients are followed periodically.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2007-10-01
• Study First Submitted QC: 2007-10-01
• Study First Posted: 2007-10-02
• Primary Completion: 2009-02
• Results First Submitted: 2014-06-12
• Status Verified: 2014-08
• Results First Submitted QC: 2014-08-19
• Last Update Submitted: 2014-08-19
• Results First Posted: 2014-08-28
• Last Update Posted: 2014-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	capecitabine	Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
Arm 1	microarray analysis	Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
Arm 1	reverse transcriptase-polymerase chain reaction	Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
Arm 1	gene expression analysis	Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
Arm 1	polymorphism analysis	Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
Arm 1	cetuximab	Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
Arm 1	immunohistochemistry staining method	Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.

Primary Outcome Measures

Name	Time	Method
Response Rate	Assessment after every 2 cycles of treatment, up to 1 year.	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by spiral CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Trial Locations

Locations (2)

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States

City of Hope Medical Group; 🇺🇸 Pasadena, California, United States