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Safety and Efficacy Study of Panitumumab+Irinotecan in Patients Wild-Type (WT) KRAS Metastatic Colorectal Cancer Refractory to Irinotecan Based Chemotherapy (SPECTRA) (SPECTRA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00958386
First Posted: August 13, 2009
Last Update Posted: March 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Amgen
Information provided by (Responsible Party):
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
  Purpose
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.

Condition Intervention Phase
Metastatic Colorectal Cancer Drug: Panitumumab+irinotecan Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD):

Primary Outcome Measures:
  • Objective response rate [ Time Frame: 2009-2012 ]

Secondary Outcome Measures:
  • disease control rate [ Time Frame: 2009-2012 ]
  • duration of response [ Time Frame: 2009-2012 ]
  • time to progression [ Time Frame: 2009-2012 ]
  • time to response [ Time Frame: 2009-2012 ]
  • time to treatment failure [ Time Frame: 2009-2012 ]
  • duration of stable disease [ Time Frame: 2009-2012 ]
  • Progression free survival [ Time Frame: 2009-2012 ]
  • Overall survival [ Time Frame: 2009-2012 ]
  • Safety profile [ Time Frame: 2009-2012 ]
  • Evaluation of molecular predictive markers [ Time Frame: 2009-2012 ]

Enrollment: 61
Study Start Date: August 2009
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Panitumumab+irinotecan
Drug: Panitumumab+irinotecan

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.


  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Competent to comprehend, sign, and date an IEC-approved informed consent form.
  • Men or women 18 years of age or older at the time the written informed consent is obtained.
  • Histologically confirmed metastatic adenocarcinoma of the colon or rectum
  • Wild-Type KRAS (No mutation) by allelic discrimination on tumor DNA.
  • Karnofsky performance status ≥ 70% at the time of enrolment in the study.
  • Within seven days prior to initiating study treatment:

    • Adequate bone marrow function: neutrophils ≥ 1.5x109/ L; platelets ≥ 100x109/L; hemoglobin ≥ 9g/dL.
    • Hepatic functions as follows: total bilirubin count ≤ 1.5 x ULN; ALAT and ASAT ≤ 2.5 x ULN (≤5 x ULN in case of liver metastasis).
    • Renal function: serum creatinine ≤1.5 ULN
    • Metabolic functions: magnesium ≥ lower limit of normal (LLN), calcium ≥ lower limit of normal (LLN)
  • Life expectancy ≥ 3 months.

Exclusion Criteria:

  • 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.
  Contacts and Locations
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): NCT00958386


Locations
Spain
Spanish Cooperative Group for Gastrointestinal Tumour Therapy
Madrid, Spain, 28046
Sponsors and Collaborators
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Amgen
Investigators
Study Chair: Josep Tabernero, MD, phD Hospital Vall de Hebrón. Barcelona. Spain
Study Chair: Enrique Aranda, MD; phD Hospital Reina Sofía. Cordoba. Madrid
  More Information

Responsible Party: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
ClinicalTrials.gov Identifier: NCT00958386     History of Changes
Other Study ID Numbers: TTD-08-06
First Submitted: August 12, 2009
First Posted: August 13, 2009
Last Update Posted: March 24, 2015
Last Verified: March 2015

Keywords provided by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD):
colorectal cancer
Panitumumab
irinotecan

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
Irinotecan
Camptothecin
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs