Clinical trial · Interventional
Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil
Phase II Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil Chemotherapy in Squamous Cell Carcinoma of the Oral Cavity With Molecular Endpoints
NCT00400205CI-TRIAL-00030225terminatedPhase 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): Safety reasons
Summary
Brief summary (as posted)
This is a Phase II study designed to test the efficacy of chemotherapy with docetaxel, cisplatinum (cisplatin) and 5-fluorouracil in patients with squamous cell carcinoma of the oral cavity to determine what effects these agents may have on cancer cells.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
- description
- Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil.
- interventionNames
- Drug: Docetaxel
- Drug: Cisplatin
- Drug: 5-fluorouracil
Primary outcomes (1)
- measure
- Number of Patients Who Had Response by RECIST Criteria (Response Evaluation Criteria in Solid Tumors)
- timeFrame
- every 3 months
- description
- Complete remission (complete disappearance of disease), partial remission \[more than 30% decrease in tumor measurement by RECIST (Response evaluation criteria in solid tumors)\].
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically proven squamous cell carcinoma of the oral cavity. * Primary tumor sites eligible: oral cavity. Although they are admittedly of squamous cell types, the following tumors will be excluded because their responsiveness to chemotherapy may differ: tumors of the nasal and paranasal cavities and of the nasopharynx. Oral cavity tumors with mandible invasion are excluded because the tumor biology and management of these tumors is more complex and will likely include upfront surgical resection. * Stage 3 or 4 disease without evidence of distant metastases verified by chest x-ray, abdominal ultrasound, or CT scan (liver function test abnormalities); bone scan in case of local symptoms. * At least one uni- or bi-dimensionally measurable lesion. * Age ≥ 18 years. * World Health Organization (WHO) performance status of 2 or less. * No active alcohol addiction. * Final eligibility for a clinical trial is determined by the health professionals conducting the trial. Exclusion Criteria: * Pregnant or breast feeding * Previous malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal, or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years. * Any prior treatment with radiotherapy or chemotherapy is an exclusion criterion. * Patients who experience an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry. * Concurrent treatment with any other anti-cancer therapy. * Participation in an investigational trial within 30 days of study entry. * Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80. * No previous chemotherapy or radiotherapy for any reason and no previous surgery for SCCHN \[squamous cell carcinoma of the head and neck\] (other than biopsy) are allowed at the time of study entry. * Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
References
Publications (1)
- RESULTSaba NF, Magliocca KR, Kim S, Muller S, Chen Z, Owonikoko TK, Sarlis NJ, Eggers C, Phelan V, Grist WJ, Chen AY, Ramalingam SS, Chen ZG, Beitler JJ, Shin DM, Khuri FR, Marcus AI. Acetylated tubulin (AT) as a prognostic marker in squamous cell carcinoma of the head and neck. Head Neck Pathol. 2014 Mar;8(1):66-72. doi: 10.1007/s12105-013-0476-6. Epub 2013 Jul 24. PMID 23881549