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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Recurrent Salivary Gland Cancer, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Nasopharynx, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Salivary Gland Squamous Cell Carcinoma, Stage III Salivary Gland Cancer, Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Nasopharynx, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IV Salivary Gland Cancer, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Larynx, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Stage IV Squamous Cell Carcinoma of the Oropharynx, Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of erlotinib and docetaxel, based on incidence of DLT graded according to NCI CTC version 2.0 (Phase I)

Outcome Time Frame:

Up to 28 days

Safety Issue:

Yes

Principal Investigator

Eric Kraut

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01432

NCT ID:

NCT00055770

Start Date:

October 2002

Completion Date:

Related Keywords:

  • Recurrent Salivary Gland Cancer
  • Recurrent Squamous Cell Carcinoma of the Hypopharynx
  • Recurrent Squamous Cell Carcinoma of the Larynx
  • Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Recurrent Squamous Cell Carcinoma of the Nasopharynx
  • Recurrent Squamous Cell Carcinoma of the Oropharynx
  • Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Salivary Gland Squamous Cell Carcinoma
  • Stage III Salivary Gland Cancer
  • Stage III Squamous Cell Carcinoma of the Hypopharynx
  • Stage III Squamous Cell Carcinoma of the Larynx
  • Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage III Squamous Cell Carcinoma of the Nasopharynx
  • Stage III Squamous Cell Carcinoma of the Oropharynx
  • Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Stage IV Salivary Gland Cancer
  • Stage IV Squamous Cell Carcinoma of the Hypopharynx
  • Stage IV Squamous Cell Carcinoma of the Larynx
  • Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IV Squamous Cell Carcinoma of the Nasopharynx
  • Stage IV Squamous Cell Carcinoma of the Oropharynx
  • Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Laryngeal Diseases
  • Salivary Gland Neoplasms
  • Hypopharyngeal Neoplasms
  • Laryngeal Neoplasms
  • Paranasal Sinus Neoplasms
  • Oropharyngeal Neoplasms
  • Nasopharyngeal Neoplasms

Name

Location

Ohio State University Medical CenterColumbus, Ohio  43210