A Study in Head and Neck Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01081041
First received: March 3, 2010
Last updated: September 6, 2013
Last verified: September 2013

March 3, 2010
September 6, 2013
July 2010
August 2013   (final data collection date for primary outcome measure)
Incidence of treatment emergent adverse events [ Time Frame: Randomization to 30 days after treatment discontinuation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01081041 on ClinicalTrials.gov Archive Site
  • Overall survival (OS) [ Time Frame: Randomization to date of death from any cause ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) [ Time Frame: Randomization to the first date of objective progression of disease or death from any cause ] [ Designated as safety issue: No ]
  • Proportion of patients having a confirmed best response of Partial Response (PR) or Complete Response (CR) [ Time Frame: Randomization to progression of disease ] [ Designated as safety issue: No ]
  • Plasma concentration of Cetuximab [ Time Frame: Cycle 1, week 1: 0 (immediately after), 1, 2 and 24 h (post-doses). Any 4 doses between Cycle 1, week 3 and Cycle 3 week 3: 0 (immediately after), 24, 96 and 168 h (post-doses) ] [ Designated as safety issue: No ]
  • Anti-Cetuximab Antibodies [ Time Frame: Day 1 of Week 1 in Cycles 1, 3, and 5, and at the 30-day follow-up visit after the end of treatment ] [ Designated as safety issue: No ]
  • Proportion of patients having a confirmed best response of PR or CR, or best response of stable disease (SD) [ Time Frame: Randomization to progression of disease ] [ Designated as safety issue: No ]
  • Cmax of Cetuximab [ Time Frame: Cycle 1, week 1: 0 (immediately after), 1, 2 and 24 h (post-doses). Any 4 doses between Cycle 1, week 3 and Cycle 3 week 3: 0 (immediately after), 24, 96 and 168 h (post-doses) ] [ Designated as safety issue: No ]
  • AUC of Cetuximab [ Time Frame: Cycle 1, week 1: 0 (immediately after), 1, 2 and 24 h (post-doses). Any 4 doses between Cycle 1, week 3 and Cycle 3 week 3: 0 (immediately after), 24, 96 and 168 h (post-doses) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study in Head and Neck Cancer
A Randomized, Double-Blind, Phase 2 Safety Study of Cetuximab, Using ImClone Versus Boehringer Ingelheim Manufacturing Processes, in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First-Line Treatment of Patients With Locoregionally Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

This study will begin with a 30 patients lead-in part: these 30 patients will receive Cetuximab manufactured by ImClone on a weekly basis in combination with other chemotherapy drugs (Cisplatin or Carboplatin plus 5-Fluorouracil) administered every 3 weeks. After 18 weeks, patients who benefit from this treatment may continue to receive cetuximab once-weekly until progression of the disease, an unacceptable side effect occurs, patients withdraw consent, or the study is closed.

In the second part of this study, 200 patients will be randomize in 2 arms:

  • 100 patients will receive commercial cetuximab manufactured by ImClone (Group A)
  • 100 patients will receive cetuximab manufactured by Boehringer Ingelheim (Group B.

All these 200 patients will receive other chemotherapy drugs (Cisplatin or Carboplatin plus 5-Fluorouracil) administered every 3 weeks. After 18 weeks, patients who benefit from this treatment may continue to receive cetuximab once-weekly until progression of the disease, an unacceptable side effect occurs, patients withdraw consent, or the study is closed.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Head and Neck Cancer
  • Drug: cetuximab
    Administered intravenously
    Other Names:
    • Erbitux
    • LY2939777
  • Drug: Cisplatin
    Administered intravenously
  • Drug: Carboplatin
    Administered intravenously
  • Drug: 5-fluorouracil
    Administered intravenously
  • Experimental: Cetuximab manufactured by Boehringer Ingelheim

    Cycle 1:

    Week 1 - Cetuximab 400 mg/m2 on day 1; Cisplatin 100 mg/m2 on day 1 or Carboplatin AUC 5 on day 1; 5-FU 1000 mg/m2 on days 1-4

    Week 2 - Cetuximab 250 mg/m2 on day 1

    Week 3 - Cetuximab 250 mg/m2 on day 1

    Cycle 2 - 6:

    Week 1 - Cetuximab 250 mg/m2 on day 1; Cisplatin 100 mg/m2 on day 1 or Carboplatin AUC 5 on day 1; 5-FU 1000 mg/m2 on days 1-4

    Week 2 - Cetuximab 250 mg/m2 on day 1

    Week 3 - Cetuximab 250 mg/m2 on day 1

    After 6 cycles, patients may then receive weekly Cetuximab monotherapy 250 mg/m2 until progression of disease, unacceptable toxicity, or another withdrawal criteria is met.

    Interventions:
    • Drug: cetuximab
    • Drug: Cisplatin
    • Drug: Carboplatin
    • Drug: 5-fluorouracil
  • Experimental: Cetuximab manufactured by ImClone

    Cycle 1:

    Week 1 - Cetuximab 400 mg/m2 on day 1; Cisplatin 100 mg/m2 on day 1 or Carboplatin AUC 5 on day 1; 5-FU 1000 mg/m2 on days 1-4

    Week 2 - Cetuximab 250 mg/m2 on day 1

    Week 3 - Cetuximab 250 mg/m2 on day 1

    Cycle 2 - 6:

    Week 1 - Cetuximab 250 mg/m2 on day 1; Cisplatin 100 mg/m2 on day 1 or Carboplatin AUC 5 on day 1; 5-FU 1000 mg/m2 on days 1-4

    Week 2 - Cetuximab 250 mg/m2 on day 1

    Week 3 - Cetuximab 250 mg/m2 on day 1

    After 6 cycles, patients may then receive weekly Cetuximab monotherapy 250 mg/m2 until progression of disease, unacceptable toxicity, or another withdrawal criteria is met.

    Interventions:
    • Drug: cetuximab
    • Drug: Cisplatin
    • Drug: Carboplatin
    • Drug: 5-fluorouracil
  • Experimental: Safety Lead in

    Cycle 1:

    Week 1 - Cetuximab 400 mg/m2 on day 1; Cisplatin 100 mg/m2 on day 1 or Carboplatin AUC 5 on day 1; 5-FU 1000 mg/m2 on days 1-4

    Week 2 - Cetuximab 250 mg/m2 on day 1

    Week 3 - Cetuximab 250 mg/m2 on day 1

    Cycle 2 - 6:

    Week 1 - Cetuximab 250 mg/m2 on day 1; Cisplatin 100 mg/m2 on day 1 or Carboplatin AUC 5 on day 1; 5-FU 1000 mg/m2 on days 1-4

    Week 2 - Cetuximab 250 mg/m2 on day 1

    Week 3 - Cetuximab 250 mg/m2 on day 1

    After 6 cycles, patients may then receive weekly Cetuximab monotherapy 250 mg/m2 until progression of disease, unacceptable toxicity, or another withdrawal criteria is met.

    Interventions:
    • Drug: cetuximab
    • Drug: Cisplatin
    • Drug: Carboplatin
    • Drug: 5-fluorouracil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
230
April 2014
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Head and neck cancer that was confirmed by tissue or cell biopsy
  • Disease not suitable for local therapy
  • Measurable or evaluable disease
  • Karnofsky performance status(KPS)score of at least 70
  • Organs are functioning well (bone marrow reserve, liver and kidney)
  • Life expectancy of at least 12 weeks
  • Signed informed consent document

Exclusion Criteria:

  • Receiving another investigational medication within the last 30 days
  • Prior chemotherapy, except if given as part of a multimodal treatment for locally advanced head and neck cancer that was completed more than 4 months prior to study entry.
  • Nasopharyngeal carcinoma
  • Previous treatment with monoclonal antibody therapy or other signal transduction inhibitors or EGFR targeting therapy except for prior cetuximab treatment given as part of a multimodal treatment for locally advanced head and neck cancer that was completed more than 4 months prior to study entry.
  • Uncontrolled high blood pressure
  • Heart disease or had a heart attack within the last year
  • Currently have an infection that requires for you to take an IV antibiotic
  • Currently receiving other therapies for your cancer, such as chemotherapy, radiation therapy, immunotherapy, and hormonal therapy
  • Medical or psychological condition that would not permit the patient to complete the study or sign informed consent
  • Known drug abuse (with the exception of alcohol abuse)
  • Known allergic reaction against any of the components of the study treatment
  • Second primary malignancy that is clinically detectable at the time of consideration for study enrollment
  • Have had another type of cancer within the last 2 years
  • You are currently pregnant or breastfeeding
  • You are considering becoming pregnant or fathering a child
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Mexico
 
NCT01081041
13611, I4E-MC-JXBD
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
September 2013

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