A Study in Head and Neck Cancer - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by (Responsible Party):	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01081041

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 II

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:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Fluorouracil Cisplatin Carboplatin Cetuximab

U.S. FDA Resources

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:	February 2013
Estimated Primary Completion Date:	February 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

Contacts

Contact: There may be multiple sites in this clinical trial (1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

Show 59 Study Locations

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:	January 20, 2012
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 February 09, 2012