Evaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients With Metastatic Colorectal Cancer
This study has been completed.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00113763
First received: June 10, 2005
Last updated: July 15, 2014
Last verified: July 2014
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Metastases |
Other: Best supportive care Drug: Panitumumab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]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:
- 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. ] [ Designated as safety issue: No ]Kaplan-Meier estimates of median time from randomization to death.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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).
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]Kaplan-Meier estimates of median time from randomization to disease progression or death due to disease progression (whichever occurs first)
- 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. ] [ Designated as safety issue: No ]Kaplan-Meier estimate of the median time from randomization to the date the decision was made to end treatment for any reason.
- 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. ] [ Designated as safety issue: No ]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.
| Enrollment: | 463 |
| Study Start Date: | January 2004 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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).
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00113763
Please refer to this study by its ClinicalTrials.gov identifier: NCT00113763
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00113763 History of Changes |
| Other Study ID Numbers: | 20020408 |
| Study First Received: | June 10, 2005 |
| Results First Received: | August 6, 2010 |
| Last Updated: | July 15, 2014 |
| Health Authority: | United States: Food and Drug Administration |
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:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 28, 2016