Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer (SPECTRUM)
- Conditions
- -C760 Head, face and neckHead, face and neckC760
- Registration Number
- PER-020-07
- Lead Sponsor
- AMGEN INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 3
1. Histological or cytological confirmation of SCCHN or its variants of the oral cavity, oropharynx, hypopharynx or larynx.
2. Diagnosis of metastatic disease and / or recurrent disease after locoregional therapy and determined as incurable by surgery or radiotherapy.
3. Subjects who received radiation as primary therapy are eligible if the locoregional recurrence is in the radiation field and occurred> 6 months after completing radiation therapy.
4. Measurable or non-measurable disease.
5. Degree of ECOG activity of 0 or 1.
6. Male or female ≥18 years of age.
7. Acceptable hematologic function.
8. Acceptable renal function.
9. Acceptable liver function.
10. Acceptable electrolytes.
11. Negative pregnancy test ≤ 72 hours before randomization.
12. The corresponding written informed consent must be obtained before any specific procedure of the study.
1. Documented or symptomatic central nervous system metastasis.
2. Antecedents of another primary tumor.
3. Subjects whose only site of metastatic disease is a single spiculated pulmonary nodule are assumed to have a second primary pulmonary nodule and are excluded unless there is clear pathological confirmation of primary SCCHN metastasis.
4. Nasopharyngeal carcinoma.
5. Previous systemic treatment for metastatic and / or recurrent SCCHN.
6. Prior systemic chemotherapy for SCCHN as part of the initial multimodal treatment for locally advanced disease if completed <6 months prior to randomization.
7. Previous induction chemotherapy with cisplatin followed by chemoradiotherapy with cisplatin
8. Previous therapy with anti-EGFr antibodies or treatment with small molecules that inhibit EGFr.
9. Subjects that require immunosuppressive agents.
10. Known allergy or hypersensitivity to any of the components of the study medication.
11. Major surgery requiring general anesthesia and a significant incision ≤ 28 days before randomization or minor surgery ≤ 14 days before randomization.
12. Clinically significant cardiovascular disease ≤ 1 year before randomization.
13. History of interstitial lung disease.
14. Symptomatic peripheral neuropathy of grade ≥ 2 based on CTCAE v3.0.
15. Hearing loss of grade ≥ 3 based on CTCAE v3.0 Hearing / Ear.
16. Subjects not recovered from all previous acute toxicity effects related to radiotherapy.
17. Active infection requiring systemic treatment or any uncontrolled infection ≤ 14 days before randomization.
18. Known positive test for infection of human immunodeficiency virus (HIV), hepatitis C virus, chronic hepatitis B infection.
19. Any condition that increases the risk of toxicity.
20. Other investigation procedures are excluded.
21. The subject is currently enrolled in another study of devices or drugs under investigation or spent ≤ 30 days from its completion, or the subject is receiving another investigational agent.
22. Pregnant or nursing woman.
23. Male or female of childbearing age who does not consent to using adequate contraceptive methods.
24. Subject who is unwilling or unable to comply with the requirements of the study.
25. Any kind of disorder that compromises the subject´s ability to give written informed consent and / or to comply with study procedures.
26. Previously randomized within this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Determination of the time from the date of randomization until the date of death.<br>Measure:General survival.<br>Timepoints:At 56 months.<br>
- Secondary Outcome Measures
Name Time Method