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Study of Erbitux (Cetuximab) Given Alone to Patients With EGFR-Undetectable Metastatic Colon or Rectal Cancer That is Refractory to Chemotherapy

This study has been completed.

Sponsors and Collaborators: ImClone Systems
Bristol-Myers Squibb
Information provided by: ImClone Systems
ClinicalTrials.gov Identifier: NCT00083720
  Purpose

This is a phase II, multicenter, open-label study of cetuximab in patients with EGFR-undetectable, metastatic colorectal carcinoma who have progressed after receiving at least one standard chemotherapeutic regimen that included a fluoropyrimidine. Target enrollment is 80 evaluable patients.

Patients with EGFR-undetectable metastatic colorectal carcinoma who have progressed after receiving at least one standard chemotherapeutic regimen that included a fluoropyrimidine, will receive an initial dose of cetuximab, 400 mg/m2 , intravenously (i.v.) over 120 minutes, followed by weekly treatment with cetuximab, 250 mg/m2 i.v. over 60 minutes. Patients who experience unacceptable toxicity or who have progressive disease will not receive further cetuximab therapy.

Patients will be evaluated for a tumor response at a minimum of every 6 weeks while on cetuximab therapy. Patients with stable disease or a partial or complete response may continue to receive weekly cetuximab therapy, unless they are dose-delayed or discontinued because of toxicity. Patients who have a partial or complete response must have a confirmatory tumor assessment no less than 4 weeks after the initial evaluation demonstrating a response. To evaluate the objective response rate, a single-stage design will be used in this study.


Condition Intervention Phase
Colorectal Neoplasms
Metastases
Neoplasm
Drug: Erbitux ™ (cetuximab)
Phase II

MedlinePlus related topics:   Cancer    Colorectal Cancer   

ChemIDplus related topics:   Cetuximab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Phase II Multicenter Study of Erbitux (Cetuximab) in Patients With Refractory, EGFR-Negative Metastatic Colorectal Carcinoma

Further study details as provided by ImClone Systems:

Primary Outcome Measures:
  • To determine the response rate of cetuximab in patients with EGFR-negative metastatic colorectal carcinoma who have progressed after receiving at least one standard chemotherapeutic regimen that included a fluoropyrimidine. [ Time Frame: Determine the response rate of cetuximab in patients with EGFR-negmetastatic colorectal carcinoma who have progressed after rec at least 1std chemo regimen that included a fluoropyrimidine. ] [ Designated as safety issue: No ]

Estimated Enrollment:   80
Study Start Date:   September 2004
Study Completion Date:   August 2007
Primary Completion Date:   August 2007 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Cetuximab at an initial dose of 400 mg/m2 intravenously (i.v.) over 120 minutes, followed by 250 nig/m2 weekly i.v. over 60 minutes
Drug: Erbitux ™ (cetuximab)
Cetuximab at an initial dose of 400 mg/m2 intravenously (i.v.) over 120 minutes, followed by 250 nig/m2 weekly i.v. over 60 minutes

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • 1) Provided signed written informed consent.
  • 2) Histologically- or pathologically- confirmed metastatic colorectal carcinoma;
  • 3) Documented progression after treatment with at least one standard chemotherapy regimen for metastatic colorectal carcinoma;
  • 4) The chemotherapy regimen on which the patient progressed, must have included a fluoropyrimidine;
  • 5) Bidimensionally measurable disease;
  • 6) Immunohistochemical evidence of an absence of EGFR expression, (ie, EGFR-negative).

Patients who do not have tumor tissue available for EGFR testing will undergo biopsy of accessible tumor. A reference laboratory designated by ImClone will perform the EGFR assay.

  • 7) Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 at study entry;
  • 8) Adequate recovery from recent surgery, chemotherapy, and radiation therapy. At least 30 days must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or medical device, or prior radiation therapy;
  • 9) Accessible for treatment and follow-up. Patients enrolled in this trial must be treated at the participating center.
  • 10) Men and women, 18 years of age and older

Exclusion Criteria:

  • 1) Women of child bearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study.
  • 2) Women who are pregnant or breastfeeding.
  • 3) Women with a positive pregnancy test on enrollment or prior to cetuximab administration.
  • 4) Sexually active fertile men not using effective birth control.
  • 5) Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
  • 6) A serious uncontrolled medical disorder that would impair the ability of the patient to receive protocol therapy;
  • 7) A history of uncontrolled angina, arrhythmias or congestive heart failure;
  • 8) Symptomatic or uncontrolled metastases to the central nervous system. Patients receiving a glucocorticoid for CNS metastases will be excluded, but those receiving anticonvulsants will be eligible.
  • 9) Any concurrent malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix. Patients with a previous malignancy but without evidence of disease for greater than or equal to 5 years will be allowed to enter the trial;
  • 10) Inadequate hematologic function defined by an absolute neutrophil count (ANC) less than 1,500/mm 3 , a platelet count less than 100,000/mm 3 , or a hemoglobin level less than 9 g/dL.
  • 11) Inadequate hepatic function, defined by a total bilirubin level greater than or equal to 1.5 times the upper limit of normal (ULN) and aspartate transaminase (AST) or alanine transaminase (ALT) levels greater than or equal to 5.0 times the ULN.
  • 12) Inadequate renal function defined by a serum creatinine level greater than 1.5 times the ULN.
  • 13) Prior cetuximab or other therapy, which specifically and directly targets the EGF pathway.
  • 14) Prior hypersensitivity reaction to chimerized or murine monoclonal antibody therapy.
  • 15) Any chemotherapy not indicated in the study protocol, radiation therapy, hormonal therapy (except for physiological replacement), or any other investigational agent.
  • 16) Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness.
  • 17) Employees of the investigator or study center with direct involvement in this study or other studies under the direction of the investigator or study center, as well as family members of the employees.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083720

Show 27 study locations  Show 27 Study Locations

Sponsors and Collaborators
ImClone Systems
Bristol-Myers Squibb

Investigators
Study Director:     Paul Windt, PharmD     ImClone Systems    
  More Information


Responsible Party:   ImClone Systems Incorporated ( Polina Binder, MD/ Medical Director, Drug Safety )
Study ID Numbers:   CP02-0451
First Received:   May 28, 2004
Last Updated:   August 6, 2008
ClinicalTrials.gov Identifier:   NCT00083720
Health Authority:   United States: Food and Drug Administration

Keywords provided by ImClone Systems:
EGFR-undetectable  
Metastatic Colorectal Cancer  

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Cetuximab
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Carcinoma
Digestive System Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2008




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