Identification of Gene Expression Signature for Panitumumab Sensitivity in Untreated Locally Advanced SCCHN

• Status: Terminated
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to identify which cancer-related genes are turned on or turned off in order to determine how well a patient will respond to the study drug, panitumumab. Panitumumab was added to standard adjuvant or primary radiation therapy. There were subjects that receive surgery followed by therapy and subjects that receive radiation therapy without surgery.

Subjects entering this study had locally advanced disease that can be treated with surgery and/or radiation therapy. Fresh frozen tumor tissue were available for genomics analysis prior to initiating panitumumab therapy. If fresh frozen tissue was not available at time of consent, a biopsy was required to participate in this trial.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neal Ready
• Collaborator: Amgen
• Treatments: Antibodies, Monoclonal; Panitumumab

Criteria

Inclusion Criteria:

1. Untreated, suspected or histologically documented locally advanced clinical stage III or IVa-b(M0)SCCHN, no evidence of distant metastases. Prior surgery with diagnosis of SCCHN acceptable

2. Candidate for definitive surgery or radiation based therapy.

3. Fresh frozen tumor tissue must be available for genomic analysis and must pass RNA Quality Control prior to research PET/CT #1 and/or initiating panitumumab

4. Measurable or evaluable disease

5. Eastern Cooperative Oncology Group (ECOG) 0-1

6. ≥18 years of age

7. Adequate organ function

1. neutrophil count (ANC or AGC) ≥1.5 x 109/L

2. Platelet count ≥75 x 109/L

3. Hemoglobin ≥9.0 g/dL

4. Creatinine ≤1.5x upper limit of normal (ULN)

5. Hepatic enzymes (AST, ALT)≤2.5x ULN, Total Bilirubin <1.5x ULN

6. Magnesium ≥ Lower limit of Normal (LLN)

8. Negative serum pregnancy test ≤7 days before starting panitumumab (for women of childbearing potential only)

9. Competent to comprehend, sign, and date a written informed consent form

10. Sexually active males & females of reproductive potential must agree to use adequate method of contraception during treatment & for 6 months after study drug stopped

Exclusion Criteria:

1. History of other malignancy within past 2 years, except:

1. Malignancy treated with curative intent and with no known active disease

2. Adequately treated non-melanomatous skin cancer or lentigo maligna with no evidence of disease

3. Adequately treated cervical carcinoma in situ with no evidence of disease

4. Prostatic intraepithelial neoplasia with no evidence of prostate cancer

2. Primary tumor of the nasopharynx (nasopharyngeal cancer), sinuses, salivary gland, or skin. (Squamous cell carcinoma arising in/near nasopharynx is eligible)

3. Prior radiotherapy in planned field if it prevents standard radiotherapy dose and field

4. Prior radiation for head & neck cancer

5. Prior anti-EGFR antibody therapy (e.g., cetuximab) or treatment with small molecule EGFR inhibitors (e.g., gefitinib, erlotinib, lapatinib)

6. Prior anti-cancer treatment with: chemotherapy, hormonal therapy, immunotherapy, experimental or approved proteins/antibodies within the past 5 years.

7. Prior systemic chemotherapy for study cancer

8. Investigational agent or therapy ≤30 days before enrollment and/or have not recovered from such side effects

9. Continued chronic use of immunosuppressive agents during the clinical trial period (e.g., methotrexate and cyclosporine), corticosteroids are allowed

10. Clinically significant cardiovascular disease (including myocardial infarction (MI), unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤6 months before enrollment

11. History of interstitial lung disease e.g., pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. Patients with CT scan findings consistent with lung scarring from chronic obstructive pulmonary disease (COPD) or previous infection are eligible

12. History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the results

13. Unwilling or unable to comply with study requirements

14. Pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment

15. Known positive test(s) for HIV infection

16. Major surgery within 2 weeks of enrollment. Staging endoscopy with biopsy/tonsillectomy for head & neck cancer, tracheostomy, and/or gastrostomy tube placement eligible one day after procedure. May consent to tissue collection biopsy pre-endoscopy/minor surgery and then begin protocol therapy one day after procedure.

17. Known allergy/hypersensitivity to any component of the study treatment(s)

18. Infection requiring intravenous antibiotics for any uncontrolled infection ≤14 days prior to enrollment

19. Subjects on anticoagulant therapy. Aspirin and other anti-platelet agents will not be defined as anticoagulant therapy for this study