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

NCT ID: NCT00538291

Last Updated: 2014-08-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

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.

Group Type: EXPERIMENTAL

cetuximab

Intervention Type: BIOLOGICAL

capecitabine

Intervention Type: DRUG

gene expression analysis

Intervention Type: GENETIC

microarray analysis

Intervention Type: GENETIC

polymorphism analysis

Intervention Type: GENETIC

reverse transcriptase-polymerase chain reaction

Intervention Type: GENETIC

immunohistochemistry staining method

Intervention Type: OTHER

Interventions

cetuximab

Intervention Type: BIOLOGICAL

capecitabine

Intervention Type: DRUG

gene expression analysis

Intervention Type: GENETIC

microarray analysis

Intervention Type: GENETIC

polymorphism analysis

Intervention Type: GENETIC

reverse transcriptase-polymerase chain reaction

Intervention Type: GENETIC

immunohistochemistry staining method

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients who's disease progressed within 6 months of previous therapy are eligible
• EGFR negative patients allowed
• No untreated or uncontrolled brain metastasis

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Absolute neutrophil count ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• ALT ≤ 5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 5 times ULN
• Serum creatinine ≤ 1.5 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• No serious intercurrent infections or medical problems
• No active or uncontrolled infections
• No significant history of uncontrolled cardiac disease, including any of the following:

• Uncontrolled hypertension
• Unstable angina
• Myocardial infarction within the past 6 months
• Uncontrolled congestive heart failure
• Cardiomyopathy with decreased ejection fraction
• No prior severe infusion reaction to a monoclonal antibody
• No known dihydropyrimidine dehydrogenase deficiency or evidence of past hypersensitivity to fluoropyrimidine

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No more than 2 prior treatments for metastatic colorectal cancer
• More than 2 weeks since prior therapy
• Prior radiotherapy allowed if < 30% of bone marrow involvement
• No other concurrent investigational agents
• No concurrent highly active antiretroviral therapy for HIV-positive patients
• No prior therapy that specifically and directly targets the EGFR pathway

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Chung, MD

Role: STUDY_CHAIR

City of Hope Comprehensive Cancer Center

Locations

City of Hope Comprehensive Cancer Center

Duarte, California, United States

City of Hope Medical Group

Pasadena, California, United States

Countries

United States

Other Identifiers

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHNMC-05033

Identifier Type: -

Identifier Source: secondary_id

CDR0000567432

Identifier Type: REGISTRY

Identifier Source: secondary_id

05033

Identifier Type: -

Identifier Source: org_study_id