NCT00139243

Brief Summary

The purpose of this study is to determine the safety and maximum tolerated dose of the combination taxotere, cisplatin, 5-fluorouracil and leucovorin. We will also preliminarily assess whether the combination is effective in treating squamous cell carcinoma of the head and neck.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 1997

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1997

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

June 4, 2008

Status Verified

June 1, 2008

Enrollment Period

8.3 years

First QC Date

August 29, 2005

Last Update Submit

June 2, 2008

Conditions

Squamous Cell CarcinomaCarcinoma of Head and/or Neck

Keywords

squamous cell carcinomaTaxoterecarcinoma of head/neckCisplatin5-FluorouracilLeucovorin

Outcome Measures

Primary Outcomes (1)

  • To determine the maximum tolerated dose of taxotere, cisplatin, 5-fluorouracil and leucovorin.

Secondary Outcomes (2)

  • To evaluate the side effects of a four day outpatient regimen with taxotere, cisplatin, 5-fluorouracil and leucovorin

  • to obtain preliminary information about the effectiveness of the drug combination.

Interventions

TaxotereDRUG
CisplatinDRUG
5-FluorouracilDRUG
LeucovorinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic documentation of squamous cell carcinoma of head and neck
  • Patients will previously untreated stage III or IV squamous cell carcinoma.
  • Patients with locally recurrent disease after surgery.
  • Life expectancy of longer than 3 months.
  • Kidney function: 1.5 or a 24 hour creatinine clearance of \> 30ml/min
  • Liver function: SGOT \< 1.5 X upper normal limit and alkaline phosphatase of \< 2.5 X upper normal limit.
  • WBC greater than or equal to 4,000/mm
  • Platelet count greater than or equal to 100,000/mm
  • Hemoglobin greater than or equal to 10gm/dl
  • Patients of child-bearing age must use effective methods of contraception.

You may not qualify if:

  • Patients treated with previous chemotherapy or radiotherapy for head and neck cancer.
  • Patients with concurrent malignancy of any site except limited basal cell carcinoma, squamous carcinoma of the skin or carcinoma in situ of the cervix.
  • Pregnant or breast-feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • Colevas AD, Norris CM, Tishler RB, Lamb CC, Fried MP, Goguen LA, Gopal HV, Costello R, Read R, Adak S, Posner MR. Phase I/II trial of outpatient docetaxel, cisplatin, 5-fluorouracil, leucovorin (opTPFL) as induction for squamous cell carcinoma of the head and neck (SCCHN). Am J Clin Oncol. 2002 Apr;25(2):153-9. doi: 10.1097/00000421-200204000-00010.

    PMID: 11943893BACKGROUND

  • 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.

    PMID: 12518365BACKGROUND

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Interventions

DocetaxelCisplatinFluorouracilLeucovorin

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and Coenzymes

Study Officials

  • Marshall Posner, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 31, 2005

Study Start

October 1, 1997

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

June 4, 2008

Record last verified: 2008-06

Locations

US(2)