Combination Chemotherapy for Locally Advanced Squamous Ce... | NCT00139230

Studies
Combination Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

NCT00139230

Sponsor

Dana-Farber Cancer Institute

Status

Completed

Last Update Posted

Jun 3, 2008Estimated

Enrollment

Phase

Phase 2

Conditions

Squamous Cell Carcinoma
Carcinoma of Head/Neck

Interventions

Taxotere
Cisplatin
5-Fluorouracil
Leucovorin
G-CSF
Ciprofloxacin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1997

Primary Completion Date

Dec 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

Aug 29, 2005

First Submission Date that Met QC Criteria

Aug 30, 2005

First Posted Date

Aug 31, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2008

Last Update Posted Date

Jun 3, 2008Estimated

Name	Class
Brigham and Women's Hospital	OTHER
Massachusetts General Hospital	OTHER
Sanofi	INDUSTRY

Description Module

Brief Summary

The purpose of this study is to further test a combination chemotherapy regimen for the treatment of squamous cell carcinoma of the head and neck and to see if the addition of supportive medicine can help reduce the side effects of these drugs.

Detailed Description

Patients will be admitted to hospital and receive a one hour infusion of taxotere. Approximately 2 hours after taxotere is finished they will receive cisplatin, 5-fluorouracil, and leucovorin continuously over a 4 day period.
Approximately 6-12 hours after the chemotherapy ends patients will be given growth factor support and ciprofloxacin until the patient's ANC level is greater than 10,000.
Infusion of chemotherapy will be repeated every 28 days (1 cycle is 28 days).
During each cycle patients will have blood tests performed weekly and may be asked to return to the Head and Neck Clinic for examination around the middle of each cycle.
At the end of each cycle the impact of the chemotherapy will be assessed. If after 2 cycles, the cancer has not responded sufficiently the patient will not receive any more chemotherapy. However, if significant reduction in the size of the patients tumor is observed, a third and final cycle will be performed.
During the fourth or fifth week of cycle 3, patients will undergo re-staging evaluation under anesthesia with primary-site biopsies and planning of radiotherapy.
Within 2 weeks of completion of chemotherapy cycle 3 all patients will receive twice daily radiotherapy.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the safety of a four day regimen of taxotere, cisplatin, 5-fluorouracil and high-dose leucovorin with growth factor support and ciprofloxacin.

Secondary Outcomes

Measure	Description	Time Frame
To determine the efficacy of this regimen in patients with advances, previously untreated squamous cell carcinoma of the head and neck.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologic confirmation of squamous cell carcinoma of head and neck.
All patients with previously untreated Stage III or IV.
Measurable disease
Complete recovery from previous diagnostic or therapeutic procedures.
Life expectancy greater than 3 months
Creatinine less than or equal to 1.5
SGOT less than 1.5 x ULN
Alkaline phosphatase less than 2.5 x ULN
WBC greater than or equal to 4,000/mm
Platelet count greater than to equal to 100,000/mm
Hemoglobin greater than or equal to 10gm/dl
Patients of childbearing age must use effective contraception methods.

Exclusion Criteria:

Patients with previous head and neck cancer except those treated with surgery only.
Patients with concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
Peripheral neuropathy exceeding grade 1.
Cardiovascular or pulmonary disease
Pregnant or breastfeeding women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marshall Posner, MD	Dana-Farber Cancer Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States
Dana-Farber Cancer Institute

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12518365	Background	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. doi: 10.1002/cncr.11063.
11943893

ID	Term
D002294	Carcinoma, Squamous Cell
D000077195	Squamous Cell Carcinoma of Head and Neck

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D000077143	Docetaxel
D002945	Cisplatin
D005472	Fluorouracil
D002955	Leucovorin
D016179	Granulocyte Colony-Stimulating Factor
D002939	Ciprofloxacin

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic

Name	Type	Description	Arm Group Labels	Other Names
Taxotere	Drug
Cisplatin	Drug
5-Fluorouracil	Drug
Leucovorin	Drug
G-CSF	Drug
Ciprofloxacin	Drug