NCT00139269

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 1998

Longer than P75 for phase_1

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

February 1, 1998

Completed
7.6 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
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

June 4, 2008

Status Verified

June 1, 2008

Enrollment Period

8.8 years

First QC Date

August 29, 2005

Last Update Submit

June 2, 2008

Conditions

Advanced Squamous Cell CarcinomaSquamous Cell Carcinoma of Head and NeckSSCHN

Keywords

Advanced Squamous Cell CarcinomaSquamous cell Carcinoma of Head and NeckSSCHNDocetaxel

Outcome Measures

Primary Outcomes (2)

  • To determine whether cisplatin in combination with docetaxel and 5-fluorouracil can be given with acceptable side effects

  • to determine the efficacy of said combination.

Secondary Outcomes (1)

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

Interventions

DocetaxelDRUG
CisplatinDRUG
5-FluorouracilDRUG

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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. doi: 10.1200/JCO.2001.19.4.1096.

    PMID: 11181674BACKGROUND

  • 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

Squamous Cell Carcinoma of Head and Neck

Interventions

DocetaxelCisplatinFluorouracil

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Marshall Posner, MD

    Dana-Farbar 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

February 1, 1998

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

June 4, 2008

Record last verified: 2008-06