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Evaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients With Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00113763
Recruitment Status : Completed
First Posted : June 13, 2005
Results First Posted : January 3, 2014
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
The purpose of this study is to determine that panitumumab, using the proposed regimen, will safely increase progression free survival in patients with metastatic colorectal cancer who have failed available treatment options (i.e., patients who developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy).

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastases Other: Best supportive care Drug: Panitumumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 463 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Phase 3 Clinical Trial of ABX-EGF Plus Best Supportive Care Versus Best Supportive Care in Subjects With Metastatic Colorectal Cancer
Study Start Date : January 2004
Actual Primary Completion Date : October 2008
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Panitumumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Panitumumab plus best supportive care
Panitumumab will be administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants develop progressive disease or are unable to tolerate study drug. Participants will also receive best supportive care (BSC) as judged appropriate by the investigator and according to institutional guidelines.
 Drug: Panitumumab
Intravenous infusion at a dose of 6 mg/kg once every 2 weeks.
Other Name: ABX-EGF
Best Supportive Care
Best supportive care will be defined in this study as the best care available as judged appropriate by the investigator and according to institutional guidelines and will include antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care will not include anti-neoplastic chemotherapy.
 Other: Best supportive care
Best supportive care as site routine excluding: antineoplastic chemotherapy, investigational agents, anti-EGFr(Epidermal growth factor receptor) targeting agents other than ABX-EGF(Panitumumab), experimental or approved anti-tumor therapies (e.g. Avastin), chemotherapy, radiotherapy (with the exception of radiotherapy for pain control limited to bone metastases).


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free Survival Time [ Time Frame: From randomization to the data cut-off date of 30 June 2005. The median follow-up time was 20.0 weeks in the panitumumab plus BSC group and 18.2 weeks in the BSC alone group. ]
    Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression, whichever occurred first. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Progressive disease defined as least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: From randomization until the data cut-off date for overall survival of 15 March 2006. The median actual follow-up time was 30 weeks for the panitumumab plus BSC group and 31 weeks for the BSC alone group. ]
    Kaplan-Meier estimates of median time from randomization to death.

  2. Objective Tumor Response [ Time Frame: From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group. ]
    Defined as the number of participants with a confirmed complete or partial tumor response, confirmed by a scan no less than 4 weeks after the criteria for response were first met. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): disappearance of all target lesions, and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease, or, at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, with no progressive disease of non-target lesions.

  3. Duration of Response [ Time Frame: From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group. ]
    Kaplan-Meier estimate of the median time from first confirmed objective tumor response to first observed progression of disease or death due to progression of disease (whichever comes first).

  4. Time to Response [ Time Frame: From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group. ]
    Time to response was defined as the time from randomization to first partial or complete response, subsequently confirmed ≥ 4 weeks after the criteria for response were first met.

  5. Time to Disease Progression [ Time Frame: From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group. ]
    Kaplan-Meier estimates of median time from randomization to disease progression or death due to disease progression (whichever occurs first)

  6. Time to Treatment Failure [ Time Frame: From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group. ]
    Kaplan-Meier estimate of the median time from randomization to the date the decision was made to end treatment for any reason.

  7. Duration of Stable Disease [ Time Frame: From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group. ]
    Kaplan-Meier estimate of the median time from randomization to date of first observed progression of disease or death due to progression of disease (whichever comes first) for those participants with a best response of stable disease. Stable disease defined as neither sufficient shrinkage to qualify for a partial response nor sufficient increase to qualify for progressive disease taking as reference the nadir longest diameter since the treatment started, no unequivocal progression of existing non-target lesions, and no new lesions.


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

Inclusion Criteria:

  • Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy)
  • Metastatic colorectal carcinoma
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Documented evidence of disease progression during, or following treatment, with fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal cancer
  • Radiographic documentation of disease progression during or within 6 months following the most recent chemotherapy regimen
  • Unidimensionally measurable disease
  • Tumor expressing epidermal growth factor receptor (EGFr) by immunohistochemistry
  • At least 2 but not more than 3 prior chemotherapy regimens for colorectal cancer
  • Adequate hematologic, renal and hepatic function

Exclusion Criteria:

  • Symptomatic brain metastases requiring treatment
  • History or evidence of interstitial pneumonitis or pulmonary fibrosis
  • Use of systemic chemotherapy or radiotherapy within 30 days prior to enrollment
  • Prior epidermal growth factor receptor (EGFr) targeting therapies
  • Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than a week) serum half life within 30 days before enrollment, or prior experimental or approved proteins within 3 months before enrollment.
Contacts and Locations
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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): NCT00113763


Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00113763    
Other Study ID Numbers: 20020408
First Posted: June 13, 2005    Key Record Dates
Results First Posted: January 3, 2014
Last Update Posted: August 7, 2018
Last Verified: August 2015
Keywords provided by Amgen:
Metastatic Colorectal Cancer, Colon
Colorectal, Rectal Cancer, Cancer
Metastatic, EGFr, Clinical Trial
Panitumumab, ABX-EGF
Immunex, Abgenix, Amgen
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Panitumumab
Antineoplastic Agents, Immunological
Antineoplastic Agents