Clinical trial · Interventional

Study of Docetaxel in Combination With Cisplatin and 5-Fluorouracil in Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Phase I/II Pilot Study of Induction Chemotherapy With Docetaxel in Combination With Cisplatin and 5-Fluorouracil (5-FU) in Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

NCT00139269CI-TRIAL-00001511completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The purpose of this study is to determine the appropriate dose, that dose which is found to give maximum effect with limited toxicity, of cisplatin in combination with docetaxel and 5-fluorouracil and then to further define the safety and effectiveness of this combination of medications.

Conditions

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Advanced Squamous Cell Carcinoma	Squamous Cell Carcinoma	CURATED_BROADER	0.78
Squamous Cell Carcinoma of Head and Neck	Head and Neck Squamous Cell Carcinoma	ALIAS	0.90
SSCHN	—	UNRESOLVED	—

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 (0)

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Primary outcomes (2)

measure
To determine whether cisplatin in combination with docetaxel and 5-fluorouracil can be given with acceptable side effects
measure
to determine the efficacy of said combination.

Secondary outcomes (1)

measure
To define the safety profile, the dose limiting toxicity and the recommended dose of cisplatin in combination with docetaxel and 5-fluorouracil.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of head and neck (SSCHN).
* At least one bi- or uni-dimensionally measurable lesion.
* Stage II or IV disease without evidence of distant metastasis.
* No previous chemotherapy, radiotherapy or surgery (other than biopsy) for SSCHN.
* Age greater than 18 years.
* ECOG performance status of 0 or 1.
* Life expectancy of greater than 12 weeks.
* Adequate bone marrow, hepatic and renal function.
* Normal serum calcium

Exclusion Criteria:

* Primary tumor location in nasopharynx, nasal cavity, sinuses, or salivary glands.
* Patients with any non-SSCHN malignancy within 5 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix.
* Any prior treatment with chemotherapy.
* Prior radiotherapy to major bone marrow area (\> 10% bone marrow) or to head and neck.
* Current peripheral neuropathy of greater than NCI grade 2.
* Other serious illness or medical condition
* Concurrent treatment with corticosteroids unless chronic treatment at low doses.
* Pregnant or lactating females or females of childbearing potential not employing adequate contraception.

References

Publications (2)

BACKGROUNDPosner MR, Glisson B, Frenette G, Al-Sarraf M, Colevas AD, Norris CM, Seroskie JD, Shin DM, Olivares R, Garay CA. Multicenter phase I-II trial of docetaxel, cisplatin, and fluorouracil induction chemotherapy for patients with locally advanced squamous cell cancer of the head and neck. J Clin Oncol. 2001 Feb 15;19(4):1096-104. doi: 10.1200/JCO.2001.19.4.1096. PMID 11181674
BACKGROUNDHaddad R, Colevas AD, Tishler R, Busse P, Goguen L, Sullivan C, Norris CM, Lake-Willcutt B, Case MA, Costello R, Posner M. Docetaxel, cisplatin, and 5-fluorouracil-based induction chemotherapy in patients with locally advanced squamous cell carcinoma of the head and neck: the Dana Farber Cancer Institute experience. Cancer. 2003 Jan 15;97(2):412-8. doi: 10.1002/cncr.11063. PMID 12518365