Cetuximab and Lenalidomide in Head and Neck

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT01133665
• Collaborator: Celgene Corporation (Industry)
• Enrollment: 42
• Location: 1
• Arm: 1
• Duration (Months): 30
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

The purpose of this study is to study specific FcRIIIa polymorphisms and their correlation with clinical outcome in subjects treated with cetuximab and lenalidomide.

Condition or Disease	Intervention/Treatment	Phase
Squamous Cell Carcinoma	Drug: Cetuximab and Lenalidomide	Phase 2

Detailed Description

To study specific FcRIIIa polymorphisms and their correlation with clinical outcome in subjects treated with cetuximab and lenalidomide. There is evidence with cetuximab in CRC, trastuzumab in breast cancer and rituximab with follicular lymphoma, that FcRIIIa polymorphisms correlate with clinical response to antibody therapy and clinical outcome. It is our hypothesis that patients with SCCHN will have clinical outcomes to cetuximab and lenalidomide that correlate with patient FcRIIIa genotype.

Secondary:

To evaluate the safety and toxicity profile of the combination of cetuximab and lenalidomide given to treat subjects with SCCHN.

To study FcRIIIa polymorphisms and the correlation with the ability of NK cells to mediate ADCC against SCCHN. It is our hypothesis that NK cells from patients with advanced SCCHN can mediate ADCC against SCCHN cell lines in the presence of cetuximab and lenalidomide and that the efficiency of ADCC correlates with FcRIIIa polymorphisms.

To evaluate the ability of NK cells to induce ADCC expression of specific activation markers on the NK cell surface. It is our hypothesis that NK cells that induce ADCC will express specific activation markers that are predictive of efficiency of ADCC.

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of Cetuximab and Lenalidomide in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sub Group 1 All Subjects Enrolled in the Trial	Drug: Cetuximab and Lenalidomide; The treatment of Head and Neck Cancer with Cetuximab and Lenalidomide

Outcome Measures

Primary Outcome Measures

1. Correlate the Presence of Specific Fc RIIIa Polymorphisms With Progression-free Survival in Subjects Receiving Cetuximab and Lenalidomide for SCCHN. [24 months]

   Progression-free survival (PFS) was defined as time from date of the first treatment dose administered to the earlier of disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Secondary Outcome Measures

1. Number of Participants With Fatigue Related to Cetuximab/Lenalidomide [24 months]

   Toxicity was scored according to NCI/CTC version 4

2. Number of Participants With Maculopapular Rash Related to Cetuximab/Lenalidomide [24 months]

   Toxicity was scored according to NCI/CTC version 4

3. Number of Participants With Constipation Related to Cetuximab/Lenalidomide [24 months]

   Toxicity was scored according to NCI/CTC version 4

4. Number of Participants With Anemia Related to Cetuximab/Lenalidomide [24 months]

   Toxicity was scored according to NCI/CTC version 4

5. Number of Participants With Anorexia Related to Cetuximab/Lenalidomide [24 months]

   Toxicity was scored according to NCI/CTC version 4

6. Number of Participants With Nausea Related to Cetuximab/Lenalidomide [24 months]

   Toxicity was scored according to NCI/CTC version 4

7. Number of Participants With Hypoalbuminemia Related to Cetuximab/Lenalidomide [24 months]

   Toxicity was scored according to NCI/CTC version 4

8. Number of Participants With Lymphopenia Related to Cetuximab/Lenalidomide [24 months]

   Toxicity was scored according to NCI/CTC version 4

9. Number of Participants With Oral Mucositis Related to Cetuximab/Lenalidomide [24 months]

   Toxicity was scored according to NCI/CTC version 4

10. Number of Participants With Pain Related to Cetuximab/Lenalidomide [24 month]

    Toxicity was scored according to NCI/CTC version 4

11. Number of Participants With Vomiting Related to Cetuximab/Lenalidomide [24 months]

    Toxicity was scored according to NCI/CTC version 4

12. Number of Participants With White Blood Cell Decreased Related to Cetuximab/Lenalidomide [24 months]

    Toxicity was scored according to NCI/CTC version 4

13. Number of Participants With Diarrhea Related to Cetuximab/Lenalidomide [24 months]

    Toxicity was scored according to NCI/CTC version 4

14. Number of Participants With Hyponatremia Related to Cetuximab/Lenalidomide [24 months]

    Toxicity was scored according to NCI/CTC version 4

15. Number of Participants With Neutropenia Related to Cetuximab/Lenalidomide [24 months]

    Toxicity was scored according to NCI/CTC version 4

16. Number of Participants With Headache Related to Cetuximab/Lenalidomide [24 month]

    Toxicity was scored according to NCI/CTC version 4

17. Number of Participants With Hypokalemia Related to Cetuximab/Lenalidomide [24 months]

    Toxicity was scored according to NCI/CTC version 4

18. Number of Participants With Hypophosphatemia Related to Cetuximab/Lenalidomide [24 month]

    Toxicity was scored according to NCI/CTC version 4

19. Number of Participants With Thrombocytopenia Related to Cetuximab/Lenalidomide [24 months]

    Toxicity was scored according to NCI/CTC version 4

20. Number of Participants With Acneiform Rash Related to Cetuximab/Lenalidomide [24 month]

    Toxicity was scored according to NCI/CTC version 4

21. Number of Participants With Hyperglycemia Related to Cetuximab/Lenalidomide [24 month]

    Toxicity was scored according to NCI/CTC version 4

22. Number of Participants With Alkaline Phosphatase Increased Related to Cetuximab/Lenalidomide [24 month]

    Toxicity was scored according to NCI/CTC version 4

23. Number of Participants With Aspartate Aminotransferase Increased Related to Cetuximab/Lenalidomide [24 month]

    Toxicity was scored according to NCI/CTC version 4

24. Number of Participants With Xerostomia Related to Cetuximab/Lenalidomide [24 months]

    Toxicity was scored according to NCI/CTC version 3

25. Number of Participants With Fever Related to Cetuximab/Lenalidomide [24 months]

    Toxicity was scored according to NCI/CTC version 4

26. Number of Participants With Hypocalcaemia Related to Cetuximab/Lenalidomide [24 months]

    Toxicity was scored according to NCI/CTC version 4

27. Number of Participants With Neck Pain Related to Cetuximab/Lenalidomide [24 month]

    Toxicity was scored according to NCI/CTC version 4

28. Number of Participants With Peripheral Sensory Neuropathy Related to Cetuximab/Lenalidomide [24 month]

    Toxicity was scored according to NCI/CTC version 4

29. Number of Participants With Alanine Aminotransferase Increased Related to Cetuximab/Lenalidomide [24 month]

    Toxicity was scored according to NCI/CTC version 4

30. Number of Participants With Back Pain Related to Cetuximab/Lenalidomide [24 month]

    Toxicity was scored according to NCI/CTC version 4

31. Number of Participants With Dyspnea Related to Cetuximab/Lenalidomide [24 month]

    Toxicity was scored according to NCI/CTC version 4

32. Number of Participants With Weight Loss Related to Cetuximab/Lenalidomide [24 month]

    Toxicity was scored according to NCI/CTC version 4

33. Number of Participants With Blood Bilirubin Increased Related to Cetuximab/Lenalidomide [24 month]

    Toxicity was scored according to NCI/CTC version 4

34. Number of Participants With Infusion Related Reaction Related to Cetuximab/Lenalidomide [24 month]

    Toxicity was scored according to NCI/CTC version 4

35. Number of Participants With C. Diff Infection Related to Cetuximab/Lenalidomide [24 month]

    Toxicity was scored according to NCI/CTC version 4

36. Number of Participants With Febrile Neutropenia Related to Cetuximab/Lenalidomide [24 month]

    Toxicity was scored according to NCI/CTC version 4

37. Number of Participants With Lymphocyte Count Increased Related to Cetuximab/Lenalidomide [24 month]

    Toxicity was scored according to NCI/CTC version 4

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Understand and voluntarily sign an informed consent form.

2. Age ≥18 years at the time of signing the informed consent form.

3. Able to adhere to the study visit schedule and other protocol requirements.

4. Recurrent or metastatic squamous cell or undifferentiated carcinoma of the head and neck that is not amenable to curative therapy. Patients who are candidates for local or locoregional therapy should not be deprived of proven beneficial palliative therapies.

5. All previous cancer therapy, including radiation, hormonal therapy, EGFR inhibitors, and surgery, must have been discontinued at least 4 weeks prior to treatment in this study.

6. ECOG performance status of 0-1 at study entry.

7. Laboratory test results within these ranges:

• Absolute neutrophil count to ≥ 1000/mm³

• Platelet count ≥ 100,000/mm³

• Calculated creatinine clearance ≥ 50ml/min by Cockcroft-Gault estimation

• Total bilirubin < 1.5 x ULN

• AST (SGOT) and ALT (SGPT) < 3 x ULN or < 5 x ULN if hepatic metastases are present.

1. Disease free of prior malignancies for < 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in-situ" of the cervix or breast. Patients with malignancies diagnosed less than 3 years prior to study entry are eligible if the first cancer was no greater than stage I and did not recur. Patients with malignancies diagnosed less than 3 years prior to study entry must have the diagnosis of recurrent or metastatic squamous cell carcinoma of the head and neck confirmed pathologically.

2. All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.

3. Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.

4. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).

5. Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded), with minimum lesion size ≥ 2 cm on conventional measurement techniques or ≥ 1 cm on spiral computed tomography (CT) scan. Lesions that can be measured clinically must be at least 1 cm in greatest dimension by caliper measurement.

Exclusion Criteria:

1. Primary head and neck carcinomas of the salivary gland, skin, or thyroid regardless of pathology

2. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.

3. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).

4. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.

5. Use of any other experimental drug or therapy within 28 days of baseline.

6. Prior therapy with lenalidomide for squamous cell carcinoma of the head and neck

7. Known hypersensitivity to thalidomide.

8. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.

9. Concurrent use of other anti-cancer agents or treatments.

10. Known positive for HIV or infectious hepatitis, type B or C.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Chicago	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago
• Celgene Corporation

Investigators

• Study Chair: Everett Vokes, M.D., University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• The University of Chicago Cancer Research Center Website

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT01133665
• Other Study ID Numbers: 09-206-B
• First Posted: May 31, 2010
• Last Update Posted: Nov 24, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by University of Chicago: Head and Neck, Squamous Cell; Recurrent or metastatic squamous cell or undifferentiated carcinoma of the head and neck that is not amenable to curative therapy
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Lenalidomide; Cetuximab

Study Results

Participant Flow

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Period Title: Overall Study
STARTED	42
COMPLETED	40
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Overall Participants	42
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	59
Sex: Female, Male (Count of Participants)
Female	10 23.8%
Male	32 76.2%

Outcome Measures

1. Primary Outcome

Title	Correlate the Presence of Specific Fc RIIIa Polymorphisms With Progression-free Survival in Subjects Receiving Cetuximab and Lenalidomide for SCCHN.
Description	Progression-free survival (PFS) was defined as time from date of the first treatment dose administered to the earlier of disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
Median (Full Range) [months]	1.8

2. Secondary Outcome

Title	Number of Participants With Fatigue Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	33 78.6%
Grade 3-4	2 4.8%

3. Secondary Outcome

Title	Number of Participants With Maculopapular Rash Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	27 64.3%
Grade 3-4	0 0%

4. Secondary Outcome

Title	Number of Participants With Constipation Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	16 38.1%
Grade 3-4	0 0%

5. Secondary Outcome

Title	Number of Participants With Anemia Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	14 33.3%
Grade 3-4	3 7.1%

6. Secondary Outcome

Title	Number of Participants With Anorexia Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	12 28.6%
Grade 3-4	1 2.4%

7. Secondary Outcome

Title	Number of Participants With Nausea Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	10 23.8%
Grade 3-4	0 0%

8. Secondary Outcome

Title	Number of Participants With Hypoalbuminemia Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	9 21.4%
Grade 3-4	0 0%

9. Secondary Outcome

Title	Number of Participants With Lymphopenia Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	9 21.4%
Grade 3-4	7 16.7%

10. Secondary Outcome

Title	Number of Participants With Oral Mucositis Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	9 21.4%
Grade 3-4	0 0%

11. Secondary Outcome

Title	Number of Participants With Pain Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 month

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	8 19%
Grade 3-4	0 0%

12. Secondary Outcome

Title	Number of Participants With Vomiting Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	8 19%
Grade 3-4	0 0%

13. Secondary Outcome

Title	Number of Participants With White Blood Cell Decreased Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	8 19%
Grade 3-4	5 11.9%

14. Secondary Outcome

Title	Number of Participants With Diarrhea Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	7 16.7%
Grade 3-4	1 2.4%

15. Secondary Outcome

Title	Number of Participants With Hyponatremia Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	7 16.7%
Grade 3-4	3 7.1%

16. Secondary Outcome

Title	Number of Participants With Neutropenia Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	7 16.7%
Grade 3-4	6 14.3%

17. Secondary Outcome

Title	Number of Participants With Headache Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 month

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	6 14.3%
Grade 3-4	1 2.4%

18. Secondary Outcome

Title	Number of Participants With Hypokalemia Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	6 14.3%
Grade 3-4	1 2.4%

19. Secondary Outcome

Title	Number of Participants With Hypophosphatemia Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 month

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	6 14.3%
Grade 3-4	1 2.4%

20. Secondary Outcome

Title	Number of Participants With Thrombocytopenia Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	6 14.3%
Grade 3-4	4 9.5%

21. Secondary Outcome

Title	Number of Participants With Acneiform Rash Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 month

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	6 14.3%
Grade 3-4	0 0%

22. Secondary Outcome

Title	Number of Participants With Hyperglycemia Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 month

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	5 11.9%
Grade 3-4	0 0%

23. Secondary Outcome

Title	Number of Participants With Alkaline Phosphatase Increased Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 month

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	4 9.5%
Grade 3-4	0 0%

24. Secondary Outcome

Title	Number of Participants With Aspartate Aminotransferase Increased Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 month

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	4 9.5%
Grade 3-4	0 0%

25. Secondary Outcome

Title	Number of Participants With Xerostomia Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 3
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	6 14.3%
Grade 3-4	0 0%

26. Secondary Outcome

Title	Number of Participants With Fever Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	4 9.5%
Grade 3-4	0 0%

27. Secondary Outcome

Title	Number of Participants With Hypocalcaemia Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	4 9.5%
Grade 3-4	0 0%

28. Secondary Outcome

Title	Number of Participants With Neck Pain Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 month

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	4 9.5%
Grade 3-4	0 0%

29. Secondary Outcome

Title	Number of Participants With Peripheral Sensory Neuropathy Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 month

Outcome Measure Data

Analysis Population Description

Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	4 9.5%
Grade 3-4	0 0%

30. Secondary Outcome

Title	Number of Participants With Alanine Aminotransferase Increased Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 month

Outcome Measure Data

Analysis Population Description

Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	3 7.1%
Grade 3-4	0 0%

31. Secondary Outcome

Title	Number of Participants With Back Pain Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 month

Outcome Measure Data

Analysis Population Description

Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	3 7.1%
Grade 3-4	0 0%

32. Secondary Outcome

Title	Number of Participants With Dyspnea Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 month

Outcome Measure Data

Analysis Population Description

Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	3 7.1%
Grade 3-4	0 0%

33. Secondary Outcome

Title	Number of Participants With Weight Loss Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 month

Outcome Measure Data

Analysis Population Description

Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	3 7.1%
Grade 3-4	0 0%

34. Secondary Outcome

Title	Number of Participants With Blood Bilirubin Increased Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 month

Outcome Measure Data

Analysis Population Description

Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	2 4.8%
Grade 3-4	1 2.4%

35. Secondary Outcome

Title	Number of Participants With Infusion Related Reaction Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 month

Outcome Measure Data

Analysis Population Description

Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	2 4.8%
Grade 3-4	1 2.4%

36. Secondary Outcome

Title	Number of Participants With C. Diff Infection Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 month

Outcome Measure Data

Analysis Population Description

Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	1 2.4%
Grade 3-4	1 2.4%

37. Secondary Outcome

Title	Number of Participants With Febrile Neutropenia Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 month

Outcome Measure Data

Analysis Population Description

Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	1 2.4%
Grade 3-4	1 2.4%

38. Secondary Outcome

Title	Number of Participants With Lymphocyte Count Increased Related to Cetuximab/Lenalidomide
Description	Toxicity was scored according to NCI/CTC version 4
Time Frame	24 month

Outcome Measure Data

Analysis Population Description

Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
Measure Participants	40
All grades	1 2.4%
Grade 3-4	1 2.4%

Adverse Events

Arm/Group Title	Cetuximab and Lenalidomide
Arm/Group Description	Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
All Cause Mortality
	Cetuximab and Lenalidomide
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Cetuximab and Lenalidomide
	Affected / at Risk (%)	# Events
Total	16/40 (40%)
Blood and lymphatic system disorders
Febrile neutropenia	1/40 (2.5%)
Cardiac disorders
Acute coronary syndrome	1/40 (2.5%)
Chest pain - cardiac	1/40 (2.5%)
Gastrointestinal disorders
Oral hemorrhage	1/40 (2.5%)
Small intestinal obstruction	1/40 (2.5%)
General disorders
Death	3/40 (7.5%)
Fever	3/40 (7.5%)
Infusion related reaction	1/40 (2.5%)
Infections and infestations
Skin infection	1/40 (2.5%)
Investigations
INR increased	1/40 (2.5%)
Neutrophil count decreased	1/40 (2.5%)
Metabolism and nutrition disorders
Dehydration	2/40 (5%)
Musculoskeletal and connective tissue disorders
Bone pain	1/40 (2.5%)
Generalized muscle weakness	1/40 (2.5%)
Trismus	1/40 (2.5%)
Respiratory, thoracic and mediastinal disorders
Aspiration	1/40 (2.5%)
Pulmonary edema	1/40 (2.5%)
Vascular disorders
Thromboembolic event	2/40 (5%)
Other (Not Including Serious) Adverse Events
	Cetuximab and Lenalidomide
	Affected / at Risk (%)	# Events
Total	39/40 (97.5%)
Blood and lymphatic system disorders
Anemia	15/40 (37.5%)
Gastrointestinal disorders
Abdominal pain	2/40 (5%)
Constipation	17/40 (42.5%)
Diarrhea	8/40 (20%)
Dry mouth	6/40 (15%)
Mucositis oral	10/40 (25%)
Nausea	11/40 (27.5%)
Oral pain	2/40 (5%)
Vomiting	8/40 (20%)
General disorders
Facial pain	3/40 (7.5%)
Fatigue	33/40 (82.5%)
Fever	6/40 (15%)
Pain	8/40 (20%)
Infections and infestations
Papulopustular rash	2/40 (5%)
Investigations
Alanine aminotransferase increased	3/40 (7.5%)
Alkaline phosphatase increased	4/40 (10%)
Aspartate aminotransferase increased	4/40 (10%)
Blood bilirubin increased	2/40 (5%)
Lymphocyte count decreased	9/40 (22.5%)
Neutrophil count decreased	6/40 (15%)
Platelet count decreased	6/40 (15%)
Weight loss	3/40 (7.5%)
White blood cell decreased	8/40 (20%)
Metabolism and nutrition disorders
Anorexia	12/40 (30%)
Hyperglycemia	7/40 (17.5%)
Hypoalbuminemia	9/40 (22.5%)
Hypocalcemia	4/40 (10%)
Hypoglycemia	2/40 (5%)
Hypokalemia	6/40 (15%)
Hypomagnesemia	2/40 (5%)
Hyponatremia	7/40 (17.5%)
Hypophosphatemia	6/40 (15%)
Musculoskeletal and connective tissue disorders
Back pain	5/40 (12.5%)
Neck pain	5/40 (12.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign	2/40 (5%)
Nervous system disorders
Dizziness	3/40 (7.5%)
Headache	6/40 (15%)
Peripheral sensory neuropathy	4/40 (10%)
Psychiatric disorders
Anxiety	2/40 (5%)
Insomnia	3/40 (7.5%)
Respiratory, thoracic and mediastinal disorders
Aspiration	2/40 (5%)
Cough	6/40 (15%)
Dyspnea	8/40 (20%)
Sore throat	2/40 (5%)
Skin and subcutaneous tissue disorders
Alopecia	2/40 (5%)
Dry skin	2/40 (5%)
Rash acneiform	6/40 (15%)
Rash maculo-papular	27/40 (67.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.