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

Squamous Cell Carcinoma of Head and Neck Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00139269
• Other study ID #: 97-199
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 29, 2005
• Last updated: June 2, 2008
• Start date: February 1998
• Est. completion date: December 2006

Study information

• Verified date: June 2008
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

• Treatment begins with a one hour infusion of docetaxel followed by a 1/2 hour infusion of cisplatin. 5-fluorouracil will be administered through continuous IV infusion through a portable pump for four days at home. A cycle is twenty-one days long ( 4 days of chemotherapy and 17 days of recovery).

• During each cycle blood tests will be performed weekly. A physical exam will be performed and the impact of the chemotherapy will be assessed at the end of each cycle.

• If after 2 cycles the patients cancer has not responded sufficiently they will be removed from the study.

• If significant reduction in the size of the tumor is observed after cycle 2, a third and final cycle will be performed. Followed by radiation therapy twice daily for approximately 6-7 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Squamous Cell Carcinoma
• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Squamous Cell Carcinoma of Head and Neck
• SSCHN

Intervention

Drug:
• Docetaxel

• Cisplatin

• 5-Fluorouracil

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital, Sanofi

References & Publications (2)

Haddad 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. — View Citation

Posner 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine whether cisplatin in combination with docetaxel and 5-fluorouracil can be given with acceptable side effects
Primary	to determine the efficacy of said combination.
Secondary	To define the safety profile, the dose limiting toxicity and the recommended dose of cisplatin in combination with docetaxel and 5-fluorouracil.