Head and Neck Cancer Clinical Trial
Official title:
Phase II Trial of Induction Therapy With Cetuximab (C225) and Carboplatin/Paclitaxel Chemotherapy in Previously Untreated Patients With Advanced (Stage IV) Head & Neck Squamous Cell Carcinoma
Verified date | February 2013 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different
ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others
interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy,
such as carboplatin, paclitaxel, and cisplatin, work in different ways to stop the growth of
tumor cells, either by killing the cells or by stopping them from dividing. Giving more than
one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses
high-energy x-rays and other types of radiation to kill tumor cells. Giving cetuximab
together with combination chemotherapy and radiation therapy, with or without cisplatin, may
kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with carboplatin
and paclitaxel followed by radiation therapy, with or without cisplatin, works in treating
patients with metastatic head and neck cancer.
Status | Completed |
Enrollment | 48 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients with histological proof (from the primary lesion and/or lymph nodes) of squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx. 2. Patients should have stage IV disease, stage T0-4 N2b/2c/3 M0 (for nasopharynx patients, stage N1 disease is eligible). Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) is required. 3. Patients with stage Tx primary disease are eligible if there is N2b/3 adenopathy. 4. Karnofsky performance status of >/= 80 or Eastern Cooperative Oncology Group (ECOG) point scale 0-1 5. Age > 16 years 6. Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of > 1500 cells/mm3 and platelet count of > 100,000 cells/mm3; adequate hepatic function with bilirubin </= Upper Limit of Normal (ULN), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) may be up to 2.5 times the upper limit of normal if alkaline phosphatase is normal. Alkaline phosphatase may be up to 4* ULN if SGPT and SGOT are normal. Patients who have both SGPT and SGOT > 1.5 ULN and alkaline phosphatase > 2.5 * ULN are not eligible. Normal PT/PTT and normal serum calcium (without intervention) are required. 7. Creatinine clearance > 40 ml/min determined by 24 hour collection or nomogram: CrCl male = (140 - age) times (weight in kg)/serum Cr times 72 CrCl female = 0.85 times (CrCl male) 8. Patients should have no serious acute or chronic co-morbid condition, or acute infection. 9. Patients must sign a study-specific informed consent form. Exclusion Criteria: 1. Histology other than squamous cell carcinoma. 2. Evidence of distant metastases (below the clavicle) by clinical or radiographic means. 3. Karnofsky performance status < 80 or ECOG>1 4. Prior chemotherapy, within the previous 3 years. 5. Prior radiotherapy to the head and neck. 6. Prior cetuximab therapy, prior therapy with any other drug that targets the EGFR pathway, or prior therapy with a murine or chimeric monoclonal antibody. 7. Initial surgical resection rendering the patient clinically and radiologically disease free. 8. Simultaneous primary invasive cancers. 9. Patients with another malignancy (excluding non melanoma skin cancers, and cancers treated > 3 years prior for which patient remains continuously disease free). 10. Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. Subjects who are men must also agree to use effective contraception. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin (HCG)) within 72 hours prior to the start of study medication. 11. WOCBP using a prohibited contraceptive method. 12. Women who are pregnant or breastfeeding. 13. Women with a positive pregnancy test on enrollment or prior to study drug administration. 14. Refusal to sign the informed consent. 15. Pre-existing peripheral neuropathy Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or worse. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | M.D. Anderson Cancer Center at University of Texas | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Kies MS, Holsinger FC, Lee JJ, William WN Jr, Glisson BS, Lin HY, Lewin JS, Ginsberg LE, Gillaspy KA, Massarelli E, Byers L, Lippman SM, Hong WK, El-Naggar AK, Garden AS, Papadimitrakopoulou V. Induction chemotherapy and cetuximab for locally advanced squ — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Complete Response | Number of participants with a complete response. Complete Response (CR): Disappearance of clinical and radiological evidence of tumor. | Study period of 3 Years | No |
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