Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Analgesics

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Herbal and Botanical

Anti-Bacterial Agents

Antibiotics, Antitubercular

Mitogens

Panitumumab

Antineoplastic Agents, Immunological

Cola

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.

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.

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).

Best supportive care

Intravenous infusion at a dose of 6 mg/kg once every 2 weeks.

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).

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

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

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.

Kaplan-Meier estimates of median time from randomization to death.

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.

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 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.

Kaplan-Meier estimates of median time from randomization to disease progression or death due to disease progression (whichever occurs first)

Kaplan-Meier estimate of the median time from randomization to the date the decision was made to end treatment for any reason.

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.

Amgen

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Safety Analysis set includes all randomized patients, analyzed according to the treatment they actually received. Hence, 2 patients randomized to Panitumumab Plus BSC treatment group are analyzed in the BSC Alone group for safety.

Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.

Panitumumab Plus BSC

Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including 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 does not include anti-neoplastic chemotherapy.

BSC Alone

Total

Age, Continuous

Sex: Female, Male

Japanese

Aborigine

Other

American Indian or Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White or Caucasian

Hispanic or Latino

Race/Ethnicity, Customized

Central and Eastern Europe

Western Europe

Rest of World

Central and Eastern Europe includes the Czech Republic, Greece, Hungary, and the Slovak Republic. Rest of World includes Australia, Canada and New Zealand. Western Europe includes Austria, Belgium, France, Germany, Italy, Portugal, Spain, Switzerland, and the Netherlands.

Region of Enrollment

0 or 1

Scale used to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self care, confined to a bed or chair \> 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.

Eastern Cooperative Oncology Group (ECOG) performance status

Study Director

Null hypothesis was no difference between treatment groups

Progression-free Survival Time

Overall Survival

Objective Tumor Response

Intention-to-treat participants who had a confirmed objective tumor response. No objective tumor responses were observed in the BSC alone treatment arm.

Duration of Response

Intention-to-treat (ITT) participants who had a confirmed objective tumor response. No objective tumor responses were observed in the BSC alone treatment arm.

Time to Response

Time to Disease Progression

Time to Treatment Failure

Participants who had a best overall response of stable disease

Duration of Stable Disease

Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression among participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) status. 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.

Panitumumab Plus Best Supportive Care

Wild-type KRAS Efficacy Analysis Set, a subset of the Intention-to-Treat set with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.

Progression-free Survival Time (Wild-type KRAS)

Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression among participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) status. 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.

Mutant KRAS Efficacy Analysis Set, a subset of the Intention-to-Treat set with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.

Spots Global Cancer Trial Database for Evaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients With Metastatic Colorectal Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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