Safety and Efficacy Study of Panitumumab+Irinotecan in Patients Wild-Type (WT) KRAS Metastatic Colorectal Cancer Refractory to Irinotecan Based Chemotherapy (SPECTRA)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Spanish Cooperative Group for Gastrointestinal Tumour Therapy
First received: August 12, 2009
Last updated: February 19, 2013
Last verified: February 2013
The purpose of the study is to evaluate the efficacy and safety of the combination of Panitumumab with Irinotecan in patients with Wild-Type KRAS metastatic colorectal cancer refractory to irinotecan based chemotherapy.
Metastatic Colorectal Cancer
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Open, Multicenter Phase II Study to Evaluate the Efficacy and Safety of the Combination of Panitumumab With Irinotecan in Patients With Wild-Type KRAS Metastatic Colorectal Cancer Refractory to Irinotecan Based Chemotherapy
Primary Outcome Measures:
- Objective response rate [ Time Frame: 2009-2012 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- disease control rate [ Time Frame: 2009-2012 ] [ Designated as safety issue: No ]
- duration of response [ Time Frame: 2009-2012 ] [ Designated as safety issue: No ]
- time to progression [ Time Frame: 2009-2012 ] [ Designated as safety issue: No ]
- time to response [ Time Frame: 2009-2012 ] [ Designated as safety issue: No ]
- time to treatment failure [ Time Frame: 2009-2012 ] [ Designated as safety issue: No ]
- duration of stable disease [ Time Frame: 2009-2012 ] [ Designated as safety issue: No ]
- Progression free survival [ Time Frame: 2009-2012 ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 2009-2012 ] [ Designated as safety issue: No ]
- Safety profile [ Time Frame: 2009-2012 ] [ Designated as safety issue: Yes ]
- Evaluation of molecular predictive markers [ Time Frame: 2009-2012 ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||February 2013 (Final data collection date for primary outcome measure)
Panitumumab will be administered as a 60 minute ± 15 minutes IV infusion, just prior to administration of chemotherapy at a dose of 6 mg/kg on day 1 of each cycle. A cycle of Panitumumab is defined as 14 days.
Irinotecan chemotherapy (180 mg/m2 in 90 min on day 1 of each cycle) will be administered after the administration of Panitumumab.
Each treatment cycle will have a duration of 14 days.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Prior malignant tumor in the last 5 years, except a history of basal cell carcinoma of the skin or pre-invasive cervical cancer.
- Unresolved toxicities from prior systemic therapy that, in the opinion of the investigator, does not qualify the patient for inclusion.
- Documented or suspected central nervous system metastases.
- Hormonal therapy, immunotherapy or experimental or approved proteins/antibodies (eg, Bevacizumab) ≤ 30 days before inclusion.
- Significant cardiovascular disease including unstable angina or myocardial infarction within 12 months before initiating study treatment or a history of ventricular arrhythmia.
- Prior anti-EGFr antibody therapy (eg, Cetuximab) or treatment small molecule EGFr tyrosine kinase inhibitors (eg, Erlotinib) or EGFR signal transduction inhibitors. Subjects who discontinue their first dose of anti-EGFR therapy (Cetuximab) because of an infusion reaction may participate in this clinical trial.
- Paraffin-embedded tissue or unstained tumor slides from primary or metastatic tumor not available (blocks available for Translational research).
- History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest CT scan.
- Treatment for systemic infection within 14 days before initiating study treatment.
- Acute or sub-acute intestinal occlusion and /or active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as > 4 loose stools per day).
- History of Gilbert's syndrome or dihydropyrimidine deficiency.
- History of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results.
- Known positive test for human immunodeficiency virus infection, hepatitis C virus, and chronic active hepatitis B infection.
- Subject allergic to the ingredients of the study medication or to Staphylococcus protein A.
- Any co-morbid disease that would increase risk of toxicity.
- Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures.
- Any investigational agent within 30 days before initiation of the treatment.
- Subject who is pregnant or breast feeding.
- Surgery (excluding diagnostic biopsy or central venous catheter placement) and/or radiotherapy within 28 days prior to initiation of study treatment.
- Woman or man of childbearing potential not consenting to use adequate contraceptive precautions i.e. double barrier contraceptive methods (e.g. diaphragm plus condom), or abstinence during the course of the study and for 6 months after the last study drug administration for women, and 1 month for men.
- Subject unwilling or unable to comply with study requirements.
- Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958386
|Spanish Cooperative Group for Gastrointestinal Tumour Therapy
|Madrid, Spain, 28046 |
Spanish Cooperative Group for Gastrointestinal Tumour Therapy
||Josep Tabernero, MD, phD
||Hospital Vall de Hebrón. Barcelona. Spain
||Enrique Aranda, MD; phD
||Hospital Reina Sofía. Cordoba. Madrid
No publications provided
||Spanish Cooperative Group for Gastrointestinal Tumour Therapy
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 12, 2009
||February 19, 2013
||Spain: Spanish Agency of Medicines
Keywords provided by Spanish Cooperative Group for Gastrointestinal Tumour Therapy:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 17, 2013
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Antineoplastic Agents, Phytogenic
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Molecular Mechanisms of Pharmacological Action