Trial record 1 of 1 for:    I4E-MC-JXBD
Previous Study | Return to List | Next Study

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
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: cetuximab
Drug: Cisplatin
Drug: Carboplatin
Drug: 5-fluorouracil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Incidence of treatment emergent adverse events [ Time Frame: Randomization to 30 days after treatment discontinuation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 230
Study Start Date: July 2010
Estimated Study Completion Date: April 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 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.

Drug: cetuximab
Administered intravenously
Other Names:
  • Erbitux
  • LY2939777
Drug: Cisplatin
Administered intravenously
Drug: Carboplatin
Administered intravenously
Drug: 5-fluorouracil
Administered intravenously
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.

Drug: cetuximab
Administered intravenously
Other Names:
  • Erbitux
  • LY2939777
Drug: Cisplatin
Administered intravenously
Drug: Carboplatin
Administered intravenously
Drug: 5-fluorouracil
Administered intravenously

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081041

  Hide Study Locations
Locations
United States, Arizona
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tucson, Arizona, United States, 85715
United States, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fullerton, California, United States, 92835
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Long Beach, California, United States, 90813
United States, Colorado
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Grand Junction, Colorado, United States, 81501
United States, Florida
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Weston, Florida, United States, 33331
United States, Georgia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Albany, Georgia, United States, 31701
United States, Illinois
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chicago, Illinois, United States, 60612
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Springfield, Illinois, United States, 62703
United States, Indiana
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
New Albany, Indiana, United States, 47150
United States, Kansas
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Wichita, Kansas, United States, 67214
United States, New York
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Albany, New York, United States, 12208
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
New York, New York, United States, 10029
United States, Oregon
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Portland, Oregon, United States, 97207
United States, South Carolina
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Charleston, South Carolina, United States, 29425
United States, Texas
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Abilene, Texas, United States, 79606
Canada, Alberta
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Calgary, Alberta, Canada, T2N 4N2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
London, Ontario, Canada, N6A 4L6
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ottawa, Ontario, Canada, K1H 8L6
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Montreal, Quebec, Canada, H2L 4M1
Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chihuahua, Mexico, 31000
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Guadalajara, Mexico, 44200
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Merida, Mexico, 97000
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mexico City, Mexico, 14000
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Monterrey, Mexico, 64320
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01081041     History of Changes
Other Study ID Numbers: 13611, I4E-MC-JXBD
Study First Received: March 3, 2010
Last Updated: September 6, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Mexico: Ethics Committee
Mexico: Ministry of Health

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cetuximab
Cisplatin
Fluorouracil
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 17, 2014