Expired Study
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Evansville, Indiana 47714


Purpose:

This is a phase II, multicenter, open-label study of cetuximab in patients with epidermal growth factor receptor (EGFR) negative, 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-negative 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 (PD) 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 (SD), partial response (PR), or a complete response (CR) may continue to receive weekly cetuximab therapy, unless they are dose-delayed or discontinued because of toxicity. Patients who have a PR or CR 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.


Criteria:

Inclusion Criteria: - Provided signed written informed consent. - Histologically- or pathologically- confirmed metastatic colorectal carcinoma; - Documented PD after treatment with at least one standard chemotherapy regimen for metastatic colorectal carcinoma; - The chemotherapy regimen on which the patient progressed, must have included a fluoropyrimidine; - Bidimensionally measurable disease; - 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. - Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 at study entry; - 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; - Accessible for treatment and follow-up. Patients enrolled in this trial must be treated at the participating center. - Men and women, 18 years of age and older Exclusion Criteria: - 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. - Women who are pregnant or breastfeeding. - Women with a positive pregnancy test on enrollment or prior to cetuximab administration. - Sexually active fertile men not using effective birth control. - Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent; - A serious uncontrolled medical disorder that would impair the ability of the patient to receive protocol therapy; - A history of uncontrolled angina, arrhythmias or congestive heart failure; - Symptomatic or uncontrolled metastases to the central nervous system. Patients receiving a glucocorticoid for central nervous system (CNS) metastases will be excluded, but those receiving anticonvulsants will be eligible. - 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; - Inadequate hematologic function defined by an absolute neutrophil count (ANC) less than 1,500/mm3 , a platelet count less than 100,000/mm3 , or a hemoglobin level less than 9 g/dL. - 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. - Inadequate renal function defined by a serum creatinine level greater than 1.5 times the ULN. - Prior cetuximab or other therapy, which specifically and directly targets the EGF pathway. - Prior hypersensitivity reaction to chimerized or murine monoclonal antibody therapy. - Any chemotherapy not indicated in the study protocol, radiation therapy, hormonal therapy (except for physiological replacement), or any other investigational agent. - Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness. - 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.


Study is Available At:


Original ID:

CP02-0451


NCT ID:

NCT00083720


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

A Phase II Multicenter Study of Erbitux (Cetuximab) in Patients With Refractory, EGFR-Negative Metastatic Colorectal Carcinoma


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

ImClone LLC


Oversight Authority:

  • United States: Food and Drug Administration
  • Canada: Ethics Review Committee
  • Canada: Health Canada


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

87


Enrollment Type:

Actual


Overall Contact Information

Official Name:E-mail: ClinicalTrials@ ImClone.com
Study Chair
ImClone LLC

Study Dates

Start Date:October 2004
Completion Date:April 2008
Completion Type:Actual
Primary Completion Date:April 2008
Primary Completion Type:Actual
Verification Date:April 2010
Last Changed Date:April 8, 2010
First Received Date:May 28, 2004
First Results Date:April 16, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure:Percentage of Participants With an Overall Resonse
Time Frame:Tumor evaluations were performed at a minimum every 6 weeks while on cetuximab therapy until progres
Safety Issues:False
Description:Determine the response rate (complete response [CR] and partial response [PR]) in patients with epidermal growth factor receptor (EGFR)-negative metastatic colorectal carcinoma treated with cetuximab, as classified by the investigator according to the Wor
Outcome Type:Primary Outcome
Measure:Number of Participants With Adverse Events
Time Frame:An adverse event (AE) was included in the safety analysis if its onset date occurred anytime during
Safety Issues:True
Description:Reported adverse events (AEs) per patient were coded according to the corresponding preferred term and system organ class in the Medical Dictionary for Regulatory Activities dictionary. The National Cancer Insititute-Common Terminology Criteria for Advers
Outcome Type:Primary Outcome
Measure:Number of Participants With Serious Adverse Events
Time Frame:A serious adverse event (SAE) was included in the safety analysis if its onset date occurred anytime
Safety Issues:True
Description:Reported SAEs per patient were coded according to the corresponding preferred term and system organ class in the Medical Dictionary for Regulatory Activities. The NCI-CTCAE Version 3.0 was used to grade all SAEs. An SAE was any untoward medical occurrenc
Outcome Type:Secondary Outcome
Measure:Percentage of Participants With Disease Control (CR, PR, or SD)
Time Frame:Tumor evaluations were performed at a minimum of every 6 weeks while on cetuximab therapy. Patients
Safety Issues:False
Description:This is the total number of patients with a best overall response of CR, PR, and stable disease (SD) divided by the total number of patients treated.
Outcome Type:Secondary Outcome
Measure:Duration of Response
Time Frame:The duration of response was measured from the date of response to the first date of PD (range 2 to
Safety Issues:False
Description:In patients with a best overall response of CR or PR, the duration of response is measured from the date criteria are first met for CR or PR, until the first date that Progressive Disease (PD) is objectively documented or death occurs. Duration of respon
Outcome Type:Secondary Outcome
Measure:Time to Progression
Time Frame:Patients with PD after receiving at least one standard chemotherapeutic regimen that included a fluo
Safety Issues:False
Description:This measure was defined as the time from the first day of treatment until the date of PD. Deaths without objective progression were censored. Patients who did not progress were censored at their last day of tumor assessment.
Outcome Type:Secondary Outcome
Measure:Overall Survival
Time Frame:Survival information was collected every 3 months after completion of therapy and/or follow-up up to
Safety Issues:False
Description:This measure is defined as the time from the first day of therapy to the date of death. Survival of living patients or those lost to follow-up were censored on the last date the patients were known to be alive.

Study Interventions

Intervention Type:Biological
Name:cetuximab
Description:Initial dose of 400 mg/m2 intravenously (i.v.) over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
Arm Name:cetuximab
Other Name:Erbitux™

Study Arms

Study Arm Type:Experimental
Arm Name:cetuximab
Description:Initial dose of 400 mg/m2 intravenously (i.v.) over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:ImClone LLC
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Bristol-Myers Squibb

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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