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Trial record 1 of 1 for:    NCT01704703
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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)

Tracking Information
First Submitted Date  ICMJE September 27, 2012
First Posted Date  ICMJE October 11, 2012
Last Update Posted Date August 1, 2017
Study Start Date  ICMJE October 2012
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2012)
Objective response rate (TRO) [ Time Frame: 4 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2012)
  • disease control rate (TCE) [ Time Frame: 4 years ]
  • duration of response (DR) [ Time Frame: 4 years ]
  • time to response(THR) [ Time Frame: 4 years ]
  • time to progression (THP) [ Time Frame: 4 years ]
  • time to treatment failure (THF) [ Time Frame: 4 years ]
  • duration of stable disease (DEE) [ Time Frame: 4 years ]
  • Progression free survival (SLP) [ Time Frame: 4 years ]
  • Overall survival (SG) [ Time Frame: 4 years ]
  • Adverse events [ Time Frame: 4 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stage IV Colorectal Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Experimental
FOLFIRI + panitumumab
Interventions:
  • Drug: panitumumab
  • Drug: FOLFIRI
Publications * Santos C, Azuara D, Viéitez JM, Páez D, Falcó E, Élez E, López-López C, Valladares M, Robles-Díaz L, García-Alfonso P, Bugés C, Durán G, Salud A, Navarro V, Capellá G, Aranda E, Salazar R. Phase II study of high-sensitivity genotyping of KRAS, NRAS, BRAF and PIK3CA to ultra-select metastatic colorectal cancer patients for panitumumab plus FOLFIRI: the ULTRA trial. Ann Oncol. 2019 May 1;30(5):796-803. doi: 10.1093/annonc/mdz082.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2017)
72
Original Estimated Enrollment  ICMJE
 (submitted: October 10, 2012)
50
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01704703
Other Study ID Numbers  ICMJE TTD-12-03
2012-001955-38 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Study Sponsor  ICMJE Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ramón Salazar, MD, PhD Institut Català d´Oncologia (ICO) L'Hospitalet
Study Chair: Gabriel Capella Institut Català d´Oncologia (ICO) L'Hospitalet
PRS Account Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP