Erlotinib Plus Docetaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Head and Neck Cancer
A Phase I and Phase II Study of OSI-774 in Combination With Docetaxel in Squamous Cell Carcinoma of the Head and Neck
8 other identifiers
interventional
45
1 country
1
Brief Summary
Phase I/II trial to study the effectiveness of combining erlotinib with docetaxel in treating patients who have locally advanced, recurrent, or metastatic head and neck cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with docetaxel may kill more tumor cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
March 6, 2003
CompletedFirst Posted
Study publicly available on registry
March 7, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedNovember 25, 2013
November 1, 2013
4.2 years
March 6, 2003
November 21, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Maximum tolerated dose of erlotinib and docetaxel, based on incidence of DLT graded according to NCI CTC version 2.0 (Phase I)
Up to 28 days
Proportion of patients with an objective response (Phase II)
Up to 6 years
Secondary Outcomes (3)
Response rate as measured by RECIST criteria (Phase II)
Up to 6 years
Time to tumor progression (Phase II)
Up to 6 years
Median survival (Phase II)
Up to 6 years
Study Arms (1)
Arm I
EXPERIMENTALPHASE I: Patients receive oral erlotinib once daily on days 1-28 and docetaxel IV over 1 hour on days 8, 15, and 22. Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional cohort of 6 patients receives erlotinib at the MTD. PHASE II: Patients receive erlotinib at the MTD and docetaxel as in phase I.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed squamous cell carcinoma of the head and neck meeting 1 of the following staging criteria:
- Recurrent
- Metastatic
- Locally advanced and determined to be incurable by surgery or radiotherapy
- Measurable disease
- No known brain metastases
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
- WBC at least 3,000/mm\^3
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- Bilirubin normal
- AST and ALT no greater than 2.5 times upper limit of normal
- Creatinine normal
- Creatinine clearance at least 60 mL/min
- +34 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Kraut
Ohio State University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2003
First Posted
March 7, 2003
Study Start
October 1, 2002
Primary Completion
December 1, 2006
Last Updated
November 25, 2013
Record last verified: 2013-11