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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
ClinicalTrials.gov Identifier:
NCT00958386
First received: August 12, 2009
Last updated: March 26, 2014
Last verified: March 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Digestive Tumour Therapy (TTD):

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: 60
Study Start Date: August 2009
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00958386

Locations
Spain
Spanish Cooperative Group for Gastrointestinal Tumour Therapy
Madrid, Spain, 28046
Sponsors and Collaborators
Spanish Cooperative Group for Digestive Tumour Therapy (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

No publications provided

Responsible Party: Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
ClinicalTrials.gov Identifier: NCT00958386     History of Changes
Other Study ID Numbers: TTD-08-06
Study First Received: August 12, 2009
Last Updated: March 26, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Spanish Cooperative Group for Digestive Tumour Therapy (TTD):
colorectal cancer
Panitumumab
irinotecan

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Antibodies, Monoclonal
Irinotecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 24, 2014