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Study of FOLFIRI + Panitumumab Using Ultra-selection Technology of Patients With Stage IV Colorectal Cancer Refractory to Irinotecan Without Any Mutation on KRAS, PIK3Ca, BRAF and NRAS Genes Detected With Highly Sensitive Techniques (ULTRA)

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ClinicalTrials.gov Identifier: NCT01704703
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Brief Summary:
Open label Phase II study of FOLFIRI + Panitumumab using ultra-selection technology with next generation high sensitivity genotyping of patients with stage IV colorectal cancer refractory to irinotecan without any mutation on KRAS, PIK3Ca, BRAF and NRAS genes detected with highly sensitive techniques.

Condition or disease Intervention/treatment Phase
Stage IV Colorectal Cancer Drug: panitumumab Drug: FOLFIRI Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Phase II Study of FOLFIRI + Panitumumab Using Ultra-selection Technology With Next Generation High Sensitivity Genotyping of Patients With Stage IV Colorectal Cancer Refractory to Irinotecan Without Any Mutation on KRAS, PIK3Ca, BRAF and NRAS Genes Detected With Highly Sensitive Techniques.
Study Start Date : October 2012
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
FOLFIRI + panitumumab
Drug: panitumumab
Panitumumab 6,0 mg/kg day 1 i.v. 60 min

Drug: FOLFIRI
Irinotecan 180 mg/m2 day 1 i.v. 30-90 min Folinic acid 400 mg/ m2 day 1 i.v. 120 min 5-FU 400 mg/ m2 day 1 Bolus 5-FU 2.400 mg/ m2 day 1 i.v. 46 hours




Primary Outcome Measures :
  1. Objective response rate (TRO) [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. disease control rate (TCE) [ Time Frame: 4 years ]
  2. duration of response (DR) [ Time Frame: 4 years ]
  3. time to response(THR) [ Time Frame: 4 years ]
  4. time to progression (THP) [ Time Frame: 4 years ]
  5. time to treatment failure (THF) [ Time Frame: 4 years ]
  6. duration of stable disease (DEE) [ Time Frame: 4 years ]
  7. Progression free survival (SLP) [ Time Frame: 4 years ]
  8. Overall survival (SG) [ Time Frame: 4 years ]
  9. Adverse events [ Time Frame: 4 years ]


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

Inclusion Criteria:

  1. Competent to understand, sign and date an IEC-approved informed consent form.
  2. Men or women 18 years of age or older at the time the written informed consent is obtained.
  3. Histologically confirmed metastatic adenocarcinoma of the colon or rectum Wild-Type RAS (No mutation) with at least 1 measurable metastatic lesion following RECIST criteria v 1.1 and initially irresectable (non suitable for radical surgery at the inclusion time).
  4. Obtention of DNA from tumor tissue blocks sent to central lab (ICO) that is amenable for highly sensitive techniques
  5. Previous irinotecan based chemotherapy +/- bevacizumab for metastatic CCR during at least 6 weeks.
  6. Irinotecan based chemotherapy does not need to be the most recent chemotherapy administrated. There are no restrictions on numbers of treatments lines before study inclusion.
  7. Disease progression during irinotecan treatment or within 6 months after irinotecan treatment.
  8. Karnofsky status ≥ 70% .
  9. Adequate bone marrow, hepatic, renal and metabolic functions,

    1. Adequate bone marrow function: neutrophils ≥ 1.5x109/ L; platelets ≥ 100x109/L; hemoglobin ≥ 9g/dL.
    2. 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).
    3. Renal function: creatinine clearance > 50 ml/min (according Cockcroft y Gault formulae)
    4. Metabolic functions: magnesium ≥ lower limit of normal (LIN)
  10. Life expectancy ≥ 3 months.

Exclusion Criteria:

  1. Prior malignant tumor in the last 5 years, except a history of basal cell carcinoma of the skin or pre-invasive cervical cancer.
  2. Unresolved toxicities from prior systemic therapy and/or radiotherapy that, in the opinion of the investigator, does not qualify the patient for inclusion.
  3. Documented or suspected central nervous system metastases.
  4. Any previous antitumoral treatment (chemotherapy, hormonal therapy, radiation treatment, surgery, immunotherapy, biologic therapy) ≤ 28 days before study inclusion.
  5. Significant cardiovascular disease including unstable angina or myocardial infarction within 12 months before initiating study treatment or a history of ventricular arrhythmia.
  6. Prior anti-EGFr antibody therapy (eg, Cetuximab) or treatment small molecule EGFr tyrosine kinase inhibitors (eg, Erlotinib). Subjects who discontinue their first dose of anti-EGFR therapy (Cetuximab) because of an infusion reaction may participate in this clinical trial.
  7. Paraffin-embedded tissue or unstained tumor slides from primary or metastatic tumor not available or quality ADN not available for biomarker determination by highly sensitive techniques.
  8. History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis.
  9. Treatment for systemic infection within 14 days before study inclusion.
  10. 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).
  11. History of Gilbert's syndrome or dihydropyrimidine deficiency.
  12. History of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results.
  13. Known positive test for human immunodeficiency virus infection, hepatitis C virus, and chronic active hepatitis B infection.
  14. Subject allergic to the ingredients of the study medication or to Staphylococcus protein A.
  15. Any co-morbid disease that would increase risk of toxicity.
  16. Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures.
  17. Subject who is pregnant or breast feeding.
  18. Surgery (excluding diagnostic biopsy or central venous catheter placement) ≤ 28 days prior study inclusion.
  19. Woman or man of childbearing potential not consenting to use adequate contraceptive precautions.
  20. Subject unwilling or unable to comply with study requirements.
  21. Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

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): NCT01704703


Locations
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Spain
Spanish Cooperative Group for Digestive Tumour Therapy
Madrid, Spain, 28046
Sponsors and Collaborators
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Investigators
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Study Chair: Ramón Salazar, MD, PhD Institut Català d´Oncologia (ICO) L'Hospitalet
Study Chair: Gabriel Capella Institut Català d´Oncologia (ICO) L'Hospitalet

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
ClinicalTrials.gov Identifier: NCT01704703     History of Changes
Other Study ID Numbers: TTD-12-03
2012-001955-38 ( EudraCT Number )
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Keywords provided by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD):
colorectal cancer
FOLFIRI
Panitumumab
KRAS, PIK3Ca,BRAF and NRAS genes
highly sensitive techniques
Additional relevant MeSH terms:
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Colorectal Neoplasms
Hypersensitivity
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Immune System Diseases
Irinotecan
Panitumumab
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological