Status:
ACTIVE_NOT_RECRUITING
Paclitaxel, Carboplatin and Cetuximab (PCC) With Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) in Previously Untreated Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Dana-Farber Cancer Institute
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn which chemotherapy combination is more effective in treating locally advanced head and neck squamous cell carcinoma. The side effects of these comb...
Detailed Description
Treatment on this study consists of 2 parts. The first part of your treatment is called induction chemotherapy and will last for 6-9 weeks, depending on which group you are in. The second part of trea...
Eligibility Criteria
Inclusion
- Patients with biopsy-proven squamous cell carcinoma of the oropharynx, oral cavity, nasopharynx, hypopharynx, or larynx.
- Biopsy material sufficient for HPV status determination available
- Patients should have stage IV disease, stage T0-4 N2b-2c/3 M0 (for nasopharynx patients, stage N1 is eligible). Measurable disease in either the T or N site by RECIST is required.
- Patients with stage Tx primary disease are eligible if there is N2b-c/3 lymphadenopathy
- ECOG PS 0-1
- Age \>/= 18 years
- Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC \>/= 1500 cells/mm\^3 and platelet count \>/= 100,000 cells/mm\^3; adequate hepatic function with bilirubin \</= ULN (excluding Gilbert's disease), AST and ALT may be up to 2.5 x ULN if alkaline phosphatase is normal. Alkaline phosphatase may be up to 4 x ULN if AST and ALT are normal. In determining eligibility the more abnormal of the two values (AST or ALT) should be used.
- Creatinine clearance \>/=40 ml/min determined by 24 hour collection or nomogram:CrCl male = (140 - age) x (wt in kg)/serum Cr x 72 or CrCl female = 0.85 x (CrCl male)
- Patients should have no serious acute or chronic co-morbid condition, or acute infection, which in the judgment of the attending physician would affect administration of the induction chemotherapy regimens.
- Patients must sign a study-specific informed consent form
Exclusion
- Histology other than squamous cell carcinoma
- Proven distant metastases (below the clavicle) by clinical or radiographic measures
- ECOG\>1
- Prior chemotherapy, within the previous 3 years
- Prior radiotherapy to the head and neck
- Prior cetuximab therapy or prior therapy with any other drug that targets the EGFR pathway
- Initial surgical resection rendering the patient clinically and radiologically disease free
- Simultaneous primary invasive cancers, excluding superficial non-melanoma skin cancers
- Patients with a history of another malignancy (excluding non melanoma skin cancers, and cancers treated \> 3 years prior for which patient remains continuously disease free
- Men and women of childbearing potential (WOCBP) unwilling to consent to using effective contraception while on treatment and for at least 3 months thereafter
- Women who are pregnant or breastfeeding
- Pre-existing peripheral neuropathy CTCAE Grade 2 or worse
- Hemoglobin \< 8.0g/dL
- Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
Key Trial Info
Start Date :
July 9 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT01154920
Start Date
July 9 2010
End Date
December 31 2027
Last Update
December 17 2025
Active Locations (2)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 20115
2
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030