A Study in Head and Neck Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01081041
First received: March 3, 2010
Last updated: April 3, 2013
Last verified: April 2013
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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 |
| Estimated 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:
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:
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:
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
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| 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: | April 3, 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 May 16, 2013