Erlotinib Plus Docetaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Head and Neck Cancer

November 21, 2013 updated by: National Cancer Institute (NCI)

A Phase I and Phase II Study of OSI-774 in Combination With Docetaxel in Squamous Cell Carcinoma of the Head and Neck

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

I. Determine the maximum tolerated dose and dose-limiting toxicity of erlotinib when administered in combination with docetaxel in patients with locally advanced, metastatic, or recurrent squamous cell carcinoma of the head and neck.

II. Determine the response rate, duration of response, time to progression, and survival of patients treated with this regimen.

III. Determine the pharmacokinetics of this regimen in these patients. IV. Correlate the presence of PTEN, RB, P-Akt, p15, p16, cyclin D1, p27, and p53 genes in tumor tissue with response in patients treated with this regimen.

OUTLINE: This is a phase I, dose-escalation study of erlotinib followed by a phase II study.

PHASE 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.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No severe pulmonary insufficiency, including chronic obstructive pulmonary disease, requiring oxygen (O2 saturation less than 90%) and/or increase in PaCO2 blood gas level greater than 50 mm Hg
  • No history of abnormality of the cornea (e.g., dry eye syndrome or Sjögren's syndrome)
  • No congenital abnormality (e.g., Fuch's dystrophy)
  • No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
  • No abnormal corneal sensitivity test (Schirmer test or similar tear production test)
  • Able to take oral medication
  • No requirement for IV alimentation
  • No active peptic ulcer disease
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No significant traumatic injury within the past 21 days
  • No prior allergic reactions to compounds of similar chemical or biological composition to study drugs
  • No grade 2 or greater persistent peripheral neuropathy
  • No other concurrent uncontrolled illness that would preclude study participation
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No prior immunotherapy for head and neck cancer
  • No more than 1 prior chemotherapy regimen in the adjuvant or neoadjuvant setting
  • No more than 1 prior chemotherapy regimen for metastatic disease
  • No prior docetaxel (phase II only)
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No prior hormonal therapy for head and neck cancer
  • Prior external beam radiotherapy allowed
  • At least 4 weeks since prior radiotherapy and recovered
  • More than 21 days since prior major surgery
  • No prior surgery affecting gastrointestinal absorption
  • No prior epidermal growth factor receptor-targeting therapy
  • No other concurrent investigational agents
  • No other concurrent anticancer therapies or agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I

PHASE 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.
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Names:
  • pharmacological studies
Drug: docetaxel
Given IV
Other Names:
  • Taxotere
  • RP 56976
  • TXT
Drug: erlotinib hydrochloride
Given orally
Other Names:
  • OSI-774
  • erlotinib
  • CP-358,774

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum tolerated dose of erlotinib and docetaxel, based on incidence of DLT graded according to NCI CTC version 2.0 (Phase I)
Time Frame: Up to 28 days
Up to 28 days
Proportion of patients with an objective response (Phase II)
Time Frame: Up to 6 years
Up to 6 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate as measured by RECIST criteria (Phase II)
Time Frame: Up to 6 years
Up to 6 years
Time to tumor progression (Phase II)
Time Frame: Up to 6 years
Up to 6 years
Median survival (Phase II)
Time Frame: Up to 6 years
Up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Eric Kraut, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

March 6, 2003

First Submitted That Met QC Criteria

March 6, 2003

First Posted (Estimate)

March 7, 2003

Study Record Updates

Last Update Posted (Estimate)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 21, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-01432 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U01CA076576 (U.S. NIH Grant/Contract)
  • OSU-0213
  • NCI-5393
  • CDR0000271197
  • OSU-02H0084
  • OSU 0213 (Other Identifier: Ohio State University Medical Center)
  • 5393 (Other Identifier: CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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