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

This study has been terminated.
(Study was terminated early due to lack of efficacy.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00538291
First Posted: October 2, 2007
Last Update Posted: August 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer Biological: cetuximab Drug: capecitabine Genetic: gene expression analysis Genetic: microarray analysis Genetic: polymorphism analysis Genetic: reverse transcriptase-polymerase chain reaction Other: immunohistochemistry staining method Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CA225103: A Phase II Study of a Combination of Cetuximab and Capecitabine in Patients With Metastatic Colorectal Cancer After Progression on Previous Fluoropyrimidine Containing Therapy

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 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.


Enrollment: 13
Study Start Date: August 2005
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Biological: cetuximab Drug: capecitabine Genetic: gene expression analysis Genetic: microarray analysis Genetic: polymorphism analysis Genetic: reverse transcriptase-polymerase chain reaction Other: immunohistochemistry staining method

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00538291


Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
City of Hope Medical Group
Pasadena, California, United States, 91105
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
Study Chair: Vincent Chung, MD City of Hope Comprehensive Cancer Center
  More Information

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00538291     History of Changes
Other Study ID Numbers: 05033
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-05033
CDR0000567432 ( Registry Identifier: NCI PDQ )
First Submitted: October 1, 2007
First Posted: October 2, 2007
Results First Submitted: June 12, 2014
Results First Posted: August 28, 2014
Last Update Posted: August 28, 2014
Last Verified: August 2014

Keywords provided by City of Hope Medical Center:
recurrent colon cancer
stage IV colon cancer
recurrent rectal cancer
stage IV rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Cetuximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents