Phase 2
N=42
Cetuximab and Combination Chemotherapy in Patients With Stage III-IV Resectable Oropharynx Cancer
Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00665392 ↗Enrolled (actual)
42
Serious AEs
31.7%
Results posted
Jun 2021
Primary outcome: Primary: Clinical and Radiological Complete Clinical Response (crCR) Rate at 3 Months — 9; 8; 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cisplatin (Drug); docetaxel (Drug); fluorouracil (Drug); Cetuximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical and Radiological Complete Clinical Response (crCR) Rate at 3 Months |
9; 8; 4 | — |
| SECONDARY Complete Clinical Response (cCR) |
17; 15; 13 | — |
| SECONDARY The 2-year Estimated Overall Survival (OS) Rate |
82 | — |
| SECONDARY Pathologic Response |
9 | — |
| SECONDARY The 2-year Estimated Progression-free Survival (PFS) |
64 | — |
| SECONDARY Complete Radiological Response (rCR) |
14; 8; 4 | — |
Summary
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, 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) together with cetuximab may kill more tumor cells.
PURPOSE: This phase II clinical trial is studying how well cetuximab given together with combination chemotherapy works in treating patients with stage III or stage IV oropharynx cancer that can be removed by surgery.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the oropharynx
- Stage III (T3 or T1-2, N1-2, M0) or nonmetastatic stage IV (T4 or T1-3, N3, M0) disease
- Resectable disease
- Measurable or evaluable disease
- Tumor tissue available
PATIENT CHARACTERISTICS:
Inclusion criteria
- WHO performance status 0-1
- ANC ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 9 g/dL
- Creatinine < 1.5 times upper limit of normal (ULN)
- Creatinine clearance ≥ 60 mL/min
- AST and ALT < 5 times ULN
- Bilirubin < 1.5 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Affiliated with social security (including CMU)
Exclusion criteria
- Cardiovascular accident (myocardial infarction, cerebral vascular accident) within the past 6 months
- Serious and/or uncontrolled cardiac or respiratory disease (pulmonary fibrosis, interstitial pneumopathy)
- Other cancer within the past 5 years except for resected skin cancer, localized cutaneous or totally resected melanoma, or resected carcinoma in situ of the cervix
- Auditory condition precluding the use of cisplatin
- Contraindication due to psychological, social, or geographical reasons that may impede proper monitoring of treatment
- Persons under guardianship or trusteeship, or prisoners of law
PRIOR CONCURRENT THERAPY:
- No prior treatment, including chemotherapy or radiotherapy
- No concurrent phenytoin, live attenuated vaccines, or parenteral aminoglycosides
Data sourced from ClinicalTrials.gov (NCT00665392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.