- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01801904
A Phase 2 Study of Panitumumab in Patients With Cetuximab-refractory Metastatic Colorectal Cancer (PACER)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study was amended with modification of inclusion criteria (from wild-type tumor KRAS gene to wild-type RAS gene, including KRAS and NRAS exons 2, 3 and 4)
RAS mutational status of tumors of patients enrolled before amendment 1 approval will be centrally revised. Patients whose tumors will result RAS mutated at the biomarkers central revision, will be replaced. Therefore, the overall sample size at both the stages may be higher than the one initially planned.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Benevento, Italy
- Ospedale Fatebenefratelli
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Napoli, Italy
- A.O.U. Policlinico Federico II
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Napoli, Italy
- Istituto Nazionale Dei Tumori
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S. Giovanni Rotondo, Italy
- Casa Sollievo Sofferenza
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-
BN
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Benevento, BN, Italy
- Azienda Ospedaliera G. Rummo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pathologic diagnosis of metastatic colorectal adenocarcinoma
- a wild-type RAS tumor (mutational status has to be determined by an experienced laboratory using validated test methods for detection of KRAS exons 2, 3, and 4, and NRAS exons 2, 3, and 4
- Failure from previous treatment with fluoropyrimidine, oxaliplatin and irinotecan. Patients may or may not have been treated with bevacizumab.
- Documented disease progression following a treatment with cetuximab in patients who showed either an objective response after 8 weeks or stable disease after 16 weeks of cetuximab treatment.
- Age at least 18 years
- ECOG Performance Status 0-2
- Neutrophils at least 1,500 mm3, platelets at least 100,000 mm3, and hemoglobin at least 9 g/dL
- Bilirubin level less than 1.5 times ULN
- AST (SGOT) and ALT (SGPT) not greater than 2.5 times ULN (or 5 times ULN in presence of liver metastasis)
- Serum creatinine less than 1.5 times ULN
- Effective contraception, if the risk of conception exists
- Life expectancy at least 3 months
- Written informed consent
Exclusion Criteria:
- Symptomatic brain metastasis
- Interstitial pneumonitis or pulmonary fibrosis
- Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)
- Chemotherapy, radiotherapy or immunotherapy within the past 4 weeks
- Any unstable systemic disease (including active infections, any significant hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study drugs or render the patient at high risk from treatment complications
- Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Panitumumab
|
6mg/kg IV given every 2 weeks until disease progression or unacceptable toxicity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of patients alive and without disease progression
Time Frame: 2 months
|
progression of disease within 2 months from registration according to RECIST criteria, and death for any cause within 2 months from registration
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
response rate
Time Frame: up to 40 weeks
|
Response assessed per patients at weeks 8,16,24,32,40 and every 3 months thereafter, using RECIST criteria
|
up to 40 weeks
|
progression free survival
Time Frame: 9 months
|
9 months
|
|
overall survival
Time Frame: one year
|
one year
|
|
worst grade toxicity per patient
Time Frame: every 2 weeks for up to 6 months
|
worst grade toxicity (according to Common Terminology Criteria for Adverse Events version 3) per patient
|
every 2 weeks for up to 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
gene expression on tumor tissue
Time Frame: one year
|
exploratory analysis of tumor-tissue for biological or genomic determinants of outcome of BRAF and P13K mutation status, EGFR and PTEN expression status
|
one year
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PACER
- 2010-024490-39 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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