Clinical trial · Interventional
Cetuximab and Radiation Therapy in Laryngeal Cancer Patients Who Have Responded to One Cycle of Chemotherapy (SPORE)
A Phase II Organ Preservation Trial Using Cetuximab and Radiation Therapy in Advanced Laryngeal Cancer Patients Who Have Responded to One Cycle of Induction Chemotherapy With Taxotere, Cisplatin, 5-Fluorouracil (TPF), and Cetuximab
NCT00599131CI-TRIAL-00020034terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was discontinued prematurely due to early stopping rules.
Summary
Brief summary (as posted)
The purpose of this study is to learn how to identify early which patients will respond to chemotherapy plus radiation therapy in order to reduce the number of subjects who require surgery (followed by radiation therapy).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Larynx | Malignant Laryngeal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Cetuximab | Drug | Cetuximab | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemotherapy/Radiation/Surgery
- description
- Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4. On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2. Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy.
- interventionNames
- Drug: Cisplatin
- Drug: Cetuximab
- Drug: 5-Fluorouracil
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Percentage of Patients Achieving Histologic Complete Response
- timeFrame
- 3 years
- description
- The proportion of patients treated with radiation+cetuximab achieving histologic CR will be estimated, along with 95% exact confidence intervals. Histologic Complete Response (CR) will be defined as primary tumors exhibiting a clinical CR or at least a 90% PR (Partial Response) along with a negative post-treatment biopsy.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have pathologically confirmed, previously untreated, resectable, squamous cell carcinoma of the larynx. * Disease must be Stage III or IV. * Tumor must be potentially surgically resectable and curable with conventional surgery and radiation therapy. * Patients must undergo pre-treatment endoscopic tumor staging and CT scanning. * ECOG Performance status 0-2 * Pre-treatment laboratory criteria: * WBC \> or = to 3500/ul, granulocyte \> or = to 1500/ul. * Platelet count \> or equal to 100,000/ul. * Calculated or measured creatinine clearance \> or = to 60 cc/min. * Total Bilirubin \< or = to 1.5 X ULN. * AST and ALT \< or = to 2.5 X ULN. * Patients must give documented informed consent to participate in this study. Exclusion Criteria: * Prior head and neck malignancy or history of other prior non-head and neck malignancy within the past 3 years. * Prior head and neck radiation or prior chemotherapy. * Documented evidence of distant metastases. * Active infection. * Pregnancy or lactation. Patients must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy. * Any medical or psychiatric illness which in the opinion of the principal investigator would compromise the patients ability to tolerate this treatment. * Patients residing in prison. * Age \< 18 years. * Patients with psychiatric/social situations that would limit compliance with study requirements are not eligible. * Patients with prior radiation to the head and neck. * Patients with prior anti-epidermal growth-factor receptor antibody therapy or therapy with a tyrosine-kinase inhibitor. * Patients with Grade \> 2 peripheral neuropathy. * Any history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
References
Publications (0)
Data not yet available
No reference posted for this study.