Cetuximab and Lenalidomide in Head and Neck

NCT01133665 | Completed Phase 2 Results DMC

• 1 other identifier: 09-206-B
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Squamous Cell Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Correlate the Presence of Specific Fc RIIIa Polymorphisms With Progression-free Survival in Subjects Receiving Cetuximab and Lenalidomide for SCCHN.

  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.

  24 months

Secondary Outcomes (37)

• Number of Participants With Fatigue Related to Cetuximab/Lenalidomide

  24 months

• Number of Participants With Maculopapular Rash Related to Cetuximab/Lenalidomide

  24 months

• Number of Participants With Constipation Related to Cetuximab/Lenalidomide

  24 months

• Number of Participants With Anemia Related to Cetuximab/Lenalidomide

  24 months

• Number of Participants With Anorexia Related to Cetuximab/Lenalidomide

  24 months

Study Arms (1)

Sub Group 1

EXPERIMENTAL

All Subjects Enrolled in the Trial

Drug: Cetuximab and Lenalidomide

Interventions

Cetuximab and Lenalidomide DRUG

The treatment of Head and Neck Cancer with Cetuximab and Lenalidomide

Sub Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand and voluntarily sign an informed consent form.
• Age ≥18 years at the time of signing the informed consent form.
• Able to adhere to the study visit schedule and other protocol requirements.
• 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.
• 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.
• ECOG performance status of 0-1 at study entry.
• 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.
• 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.
• All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
• 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.

You may not qualify if:

• Primary head and neck carcinomas of the salivary gland, skin, or thyroid regardless of pathology
• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
• 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.
• Use of any other experimental drug or therapy within 28 days of baseline.
• Prior therapy with lenalidomide for squamous cell carcinoma of the head and neck
• Known hypersensitivity to thalidomide.
• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
• Concurrent use of other anti-cancer agents or treatments.
• Known positive for HIV or infectious hepatitis, type B or C.

Sponsors & Collaborators

• University of Chicago: lead
• Celgene Corporation: collaborator

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Links

• The University of Chicago Cancer Research Center Website

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Recurrence

Interventions

Cetuximab; Lenalidomide

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Everett Vokes
• Organization: The University of Chicago

evokes@medicine.bsd.uchicago.edu

773-702-9306

Study Officials

• Everett Vokes, M.D.

  University of Chicago

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: May 31, 2010
• Study Start: February 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2012
• Last Updated: November 24, 2014
• Results First Posted: November 24, 2014

Record last verified: 2014-11

Locations

US (1)