BIBW 2992 (Afatinib) in Head & Neck Cancer

NCT ID: NCT00514943

Last Updated: 2016-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2013-07-31

Brief Summary

The primary objective of this study is to explore the efficacy of BIBW 2992 compared with cetuximab (Erbitux) in patients with metastatic or recurrent head and neck cancer after failure of platinum-containing therapy. In addition, the trial aims to clarify the influence of EGFR genotype on tumor response to the treatment regimens.

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BIBW 2992

once daily taken orally

Group Type: EXPERIMENTAL

BIBW 2992

Intervention Type: DRUG

experimental drug taken once daily orally

Cetuximab

once every week by intravenous injection

Group Type: ACTIVE_COMPARATOR

Cetuximab

Intervention Type: DRUG

active comparator administered weekly intravenously

Interventions

BIBW 2992

experimental drug taken once daily orally

Intervention Type: DRUG

Cetuximab

active comparator administered weekly intravenously

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Metastatic (stage IVc) or recurrent HNSCC 2. Histologically or cytologically confirmed diagnosis of squamous cell of the head and neck. Patients with well-differentiated (keratinizing) nasopharyngeal carcinomas and patients with squamous cell carcinomas metastatic to the neck from an unknown head and neck primary are eligible. 3. Patients must have documented progressive disease (PD) following receipt of prior platinum-based therapy (either as neoadjuvant, adjuvant, concomitant with radiotherapy, or for recurrent/ metastatic disease). 4. Patients must have measurable disease as defined by RECIST criteria. 5. Patients must have recovered from any therapy-related toxicities from previous chemo-, immuno-, or radiotherapies to CTC smaller or equal to Grade 1. 6. Patients must have recovered from previous surgery. 7. Life expectancy of at least three (3) months. 8. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0 or 1.

9. Patients must be eighteen (18) years of age or older. 10. Willingness and ability to give written informed consent consistent with ICH-GCP guidelines.

Exclusion Criteria

1. Progressive disease within 3 months after completion of curative intent treatment for localized/locoregionally advanced disease.

2. Prior use of an EGFR or erbB2 inhibitor in the recurrent/metastatic disease setting (treatment with cetuximab (Erbitux®) or other EGFR inhibitor during radiotherapy or chemoradiotherapy is permissible).

3. More than 2 chemotherapeutic regimens given for recurrent/metastatic disease.

4. Treatment with other investigational drugs, other anti-cancer-therapy (e.g., chemotherapy, immunotherapy, radiotherapy), concomitantly with therapy on this study and/or during the last four weeks, prior to the first treatment with the trial drug

5. eliminated per Amendment #1

6. Patients with history of other malignancy (except for appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least 3 years.

7. Patients with history of decompensated heart failure.

8. Cardiac left ventricular function with resting ejection fraction <50% or less than the institutional lower limit of normal by MUGA or echocardiogram.

9. Active infectious disease.

10. Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.

11. Serious illness, concomitant non-oncological disease or mental problems considered by the investigator to be incompatible with the protocol.

12. Use of alcohol or drugs incompatible with patient participation in the study in the investigator's opinion.

13. Patients unable to comply with the protocol.

14. Patients with active/symptomatic brain metastases. Patients with a history of treated brain metastases must have stable or normal cerebral MRI scan at screening and be at least three months post-radiation or surgery.

15. Absolute neutrophile count (ANC) less than 1000/mm3.

16. Platelet count less than 75,000/mm3.

17. Bilirubin greater than 1.5 mg/dl/ Higher bilirubin values are acceptable for patients with known Gilbert's disease, approval by the PI and sponsor necessary.

18. Asparate amino transferase (AST) or alanine amino transferase (ALT) greater than 3 times the upper limit of normal.

19. Serum creatinine greater than 1.5 X upper limit of normal for the institution.

20. Patients who are sexually active and unwilling to use a medically acceptable method of contraception.

21. Pregnancy or breast-feeding.

22. Patients with known pre-existing interstitial lung disease.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1200.28.0010 Boehringer Ingelheim Investigational Site

Stanford, California, United States

1200.28.0001 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

1200.28.0005 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

1200.28.0011 Boehringer Ingelheim Investigational Site

Harvey, Illinois, United States

1200.28.0022 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

1200.28.0024 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

1200.28.0012 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

1200.28.0021 Boehringer Ingelheim Investigational Site

Saint Joseph, Michigan, United States

1200.28.0016 Boehringer Ingelheim Investigational Site

Rochester, Minnesota, United States

1200.28.0002 Boehringer Ingelheim Investigational Site

Jackson, Mississippi, United States

1200.28.0006 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

1200.28.0008 Boehringer Ingelheim Investigational Site

New Hyde Park, New York, United States

1200.28.0017 Boehringer Ingelheim Investigational Site

Chapel Hill, North Carolina, United States

1200.28.0004 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

1200.28.0013 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

1200.28.0007 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

1200.28.0009 Boehringer Ingelheim Investigational Site

Madison, Wisconsin, United States

1200.28.0020 Boehringer Ingelheim Investigational Site

Milwaukee, Wisconsin, United States

1200.28.0030 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

1200.28.0031 Boehringer Ingelheim Investigational Site

Ghent, , Belgium

1200.28.0032 Boehringer Ingelheim Investigational Site

Leuven, , Belgium

1200.28.0062A Boehringer Ingelheim Investigational Site

Alès, , France

1200.28.0062B Boehringer Ingelheim Investigational Site

Alès, , France

1200.28.0059A Boehringer Ingelheim Investigational Site

Avignon, , France

1200.28.0052A Boehringer Ingelheim Investigational Site

Lille, , France

1200.28.0051A Boehringer Ingelheim Investigational Site

Lyon, , France

1200.28.0050A Boehringer Ingelheim Investigational Site

Montpellier, , France

1200.28.0058A Boehringer Ingelheim Investigational Site

Nîmes, , France

1200.28.0061A Boehringer Ingelheim Investigational Site

Poitiers, , France

1200.28.0055G Boehringer Ingelheim Investigational Site

Rouen, , France

1200.28.0040 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

1200.28.0044 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

1200.28.0043 Boehringer Ingelheim Investigational Site

Madrid, , Spain

1200.28.0042 Boehringer Ingelheim Investigational Site

Málaga, , Spain

1200.28.0045 Boehringer Ingelheim Investigational Site

Santander, , Spain

1200.28.0041 Boehringer Ingelheim Investigational Site

Valencia, , Spain

Countries

United States; Belgium; France; Spain

References

Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.

Reference Type: DERIVED

PMID: 25057165 (View on PubMed)

Other Identifiers

2008-007097-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1200.28

Identifier Type: -

Identifier Source: org_study_id