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

NCT00538291 | Terminated Phase 2 Results

• 4 other identifiers: 05033P30CA033572CHNMC-05033CDR0000567432
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Cancer

Keywords

recurrent colon cancer; stage IV colon cancer; recurrent rectal cancer; stage IV rectal cancer

Outcome Measures

Primary Outcomes (1)

• Response Rate

  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.

  Assessment after every 2 cycles of treatment, up to 1 year.

Study Arms (1)

Arm 1

EXPERIMENTAL

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.

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

Interventions

cetuximab BIOLOGICAL

Arm 1

capecitabine DRUG

Arm 1

gene expression analysis GENETIC

Arm 1

microarray analysis GENETIC

Arm 1

polymorphism analysis GENETIC

Arm 1

reverse transcriptase-polymerase chain reaction GENETIC

Arm 1

immunohistochemistry staining method OTHER

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of metastatic colorectal cancer * Measurable disease * Disease progression during prior fluoropyrimidine-containing therapy comprising irinotecan with or without oxaliplatin * Received standard first- and second-line irinotecan and oxaliplatin-based therapy * Patients who completed 1 prior treatment for metastatic disease but refused standard second-line therapy are eligible * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

City of Hope Medical Group

Pasadena, California, 91105, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Cetuximab; Capecitabine; Gene Expression Profiling; Microarray Analysis; Amplified Fragment Length Polymorphism Analysis; Reverse Transcriptase Polymerase Chain Reaction; Immunohistochemistry

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Genetic Techniques; Investigative Techniques; Microchip Analytical Procedures; DNA Fingerprinting; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Immunologic Techniques

Limitations and Caveats

Study was terminated due to a lack of efficacy (less than 2 of 13 patients responded to treatment in the first stage of a Simon's two stage design).

Results Point of Contact

• Title: Paul Frankel, Ph.D.
• Organization: City of Hope National Medical Center

pfrankel@coh.org

(626)359-8111

Study Officials

• Vincent Chung, MD

  City of Hope Comprehensive Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2007
• First Posted: October 2, 2007
• Study Start: August 1, 2005
• Primary Completion: February 1, 2009
• Last Updated: August 28, 2014
• Results First Posted: August 28, 2014

Record last verified: 2014-08

Locations

US (2)