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Treatment After Irinotecan-based Frontline Therapy: Maintenance With Erbitux (in Patients wtRAS mCRC) (TIME)

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.
 
ClinicalTrials.gov Identifier: NCT02404935
Recruitment Status : Active, not recruiting
First Posted : April 1, 2015
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
UNICANCER

Brief Summary:
National multicentric phase II trial evaluating whether single agent cetuximab is effective as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab in mCRC patients with KRAS and NRAS wild-type genes, assessed by progression-free survival at 6 months after start of maintenance therapy.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Cetuximab Drug: FOLFIRI and cetuximab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of First-line FOLFIRI Plus Cetuximab for 8 Cycles Followed by Either Single-agent Cetuximab as Maintenance Therapy or Observation in Patients With Wild-type KRAS and NRAS Metastatic Colorectal Cancer
Actual Study Start Date : November 22, 2013
Estimated Primary Completion Date : August 17, 2020
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Experimental: Arm A cetuximab
cetuximab 500 mg/m2 (every 2 weeks) until progression
Drug: Cetuximab
Drug: FOLFIRI and cetuximab
Arm B observation
observation until progression
Drug: FOLFIRI and cetuximab



Primary Outcome Measures :
  1. Progression Free Survival at 6 months [ Time Frame: 6 months after start of maintenance therapy ]
    Endpoints will include Progression assessed by CT Scan according to RECIST 1.1 criteria and Death from any cause



Information from the National Library of Medicine

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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. Histologically confirmed colorectal cancer
  2. KRAS and NRAS wild-type genes after analysis of mutation status from the primary tumour or metastasis
  3. Non resectable metastatic disease in a curative intent
  4. No prior chemotherapy except for fluoropyrimidines with or without oxaliplatin-based adjuvant treatment, at least 6 months before inclusion
  5. At least one measurable tumour target (higher than 20 mm) according to RECIST criteria, which has never been irradiated
  6. Life expectancy above 3 months
  7. Performance Status ≤2 (WHO)
  8. Patient ≥18 years-old
  9. Acceptable blood test
  10. Patient having signed a written informed consent form

Exclusion Criteria:

  1. Known and/or symptomatic brain metastases
  2. Known allergy to one of treatment components
  3. Neurological or psychiatric condition which could interfere with good treatment compliance
  4. Current anti-tumour treatment : chemotherapy or targeted therapy or radiotherapy ≤ 14 days before randomisation
  5. Other severe conditions such as: respiratory failure. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
  6. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrollment/randomization
  7. Concomitant severe infection
  8. History of cancer (except skin cancer other than melanoma or an in situ cervical epithelioma or other solid tumour treated for curative purposes without signs of the condition and with no treatment administered in the 5 years before randomisation.)
  9. Patient already included in another clinical trial with an investigational molecule
  10. Prior treatment with anti-EGFr antibodies (e.g. panitumumab (Vectibix® or cetuximab / Erbitux® ) or treatment with small EGFr inhibitor molecules (e.g., erlotinib / Tarceva®)
  11. Pregnant female, likely to be or currently breastfeeding, or planning to become pregnant within 6 months after the end of treatment or absence of effective contraception for males and females of childbearing age during treatment and for 6 months (male or female) after the end of treatment
  12. Those deprived of their freedom or under guardianship
  13. Impossibility of undergoing trial's medical follow-up for geographical, social or psychological reasons

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): NCT02404935


Locations
Show Show 47 study locations
Sponsors and Collaborators
UNICANCER
Investigators
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Principal Investigator: Valérie Boige, Dr Gustave Roussy, Cancer Campus, Grand Paris
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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT02404935    
Other Study ID Numbers: Prodige 28 - UCGI 27 (TIME)
2012-005139-99 ( EudraCT Number )
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by UNICANCER:
Metastatic colorectal cancer
cetuximab
maintenance
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents