NCT00113347

Brief Summary

The goal of this clinical research study is to find the highest safe dose of the drugs OSI-774 and docetaxel that can be given together along with radiation treatment for advanced head and neck cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1 head-and-neck-cancer

Timeline
Completed

Started Apr 2005

Longer than P75 for phase_1 head-and-neck-cancer

Geographic Reach
1 country

1 active site

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

April 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2005

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

February 27, 2012

Status Verified

February 1, 2012

Enrollment Period

6 years

First QC Date

June 7, 2005

Last Update Submit

February 23, 2012

Conditions

Head and Neck Cancer

Keywords

Head and Neck CancerSquamous Cell CarcinomaErlotinibDocetaxelRadiationRadiotherapyConcomitant Boost Radiation

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose (MTD) of erlotinib and docetaxel during concomitant boost radiation

    MTD defined as highest dose level in which 6 patients have been treated with less than or equal to 2 instances of Dose-limiting toxicity (DLT) from 2 sources: 1) Out-of-field toxicity from unirradiated sites secondary to systemic therapy(erlotinib and docetaxel); 2) In-field toxicity from irradiated sites secondary to combined treatment.

    6 weeks of treatment, followed

Study Arms (1)

Erlotinib + Docetaxel

EXPERIMENTAL

Erlotinib 100, 125, or 150 mg orally daily except days receive Docetaxel 15 mg/m\^2 or 20 mg/m\^2 intravenously with Concomitant Boost Radiation to Head/Neck

Drug: ErlotinibDrug: DocetaxelRadiation: Radiation Therapy

Interventions

ErlotinibDRUG

Beginning on Day 2 of treatment, 100, 125, or 150 mg by mouth once a day every day while on treatment, except on days docetaxel is received.

Also known as: Tarceva, OSI-774, Erlotinib Hydrochloride
Erlotinib + Docetaxel
DocetaxelDRUG

15 mg/m\^2 or 20 mg/m\^2 by vein over 15 to 30 minutes on Days 1, 8, 15, and 22 of treatment.

Also known as: Taxotere
Erlotinib + Docetaxel
Radiation TherapyRADIATION

Radiation therapy to head/neck beginning on day 1 of treatment once daily 5 times per week (Monday through Friday), delivered in 40 fractions.

Also known as: XRT, Radiotherapy
Erlotinib + Docetaxel

Eligibility Criteria

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

You may qualify if:

  • Patients with histological proof (from the primary lesion and/or lymph nodes) of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
  • Patients should have stage III or IV disease, staged T3-4 and/or N2-3, M0
  • Patients must have a Karnofsky performance status of \>= 70
  • Age \>/= 18 years
  • No hematogenous metastatic disease
  • Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of \> 1500 cells/mm\*\*3 and platelet count of \> 100,000 cells/mm\*\*3; adequate hepatic function with total bilirubin \<= Upper Limit of Normal (ULN), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) may be up to 2.5 times the upper limit of normal if alkaline phosphatase is normal. Alkaline phosphatase may be up to 4 \* ULN if aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) are normal. Patients who have SGPT \> 1.5 ULN and alkaline phosphatase \> 2.5 \* ULN are not eligible.
  • Creatinine clearance \> 50 ml/min determined by 24 hour collection or nomogram: CrCl male = (140 - age) \* (weight as kg)/serum Cr \* 72 CrCl female = 0.85 \* (CrCl male)
  • Patients must not have received previous surgery, other than diagnostic biopsy, or radiation, for this cancer. Patients may have received neoadjuvant chemotherapy which must have been completed \> 3 weeks from beginning therapy on this trial.
  • Patients with a history of non-melanoma skin cancer, or other previous malignancies treated 5 years or more prior to the current tumor from which the patient has remained continually disease-free, are eligible.
  • Patients must sign a study-specific informed consent form.
  • Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for 6 months thereafter. Childbearing potential will be defined as women who have had menses within the past 12 months, who have not had tubal ligation or bilateral oophorectomy.

You may not qualify if:

  • Histology other than squamous cell carcinoma.
  • Evidence of metastases (below the clavicle or distant) by clinical or radiographic means.
  • Karnofsky performance status \< 70
  • Prior therapy with inhibitors of epidermal growth factor receptor (EGFR)
  • Prior radiotherapy to the head and neck
  • Patients with simultaneous primaries
  • Patients with a past history of malignancy (excluding non melanoma skin cancers, and cancers treated \> 5 years prior for which patient remains continuously disease free).
  • Pregnant/breast-feeding women are ineligible.
  • Patients refusing or unable to sign the informed consent.
  • Patients with pre-existing peripheral neuropathy NCI Common Toxicity Criteria (CTC) grade 2 or worse.
  • Patients with a history of severe hypersensitivity reaction to Taxotere® and/or Polysorbate 80 must be excluded.
  • Patients may not use ketoconazole, St. John's Wort, or erythromycin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsCarcinoma, Squamous Cell

Interventions

Erlotinib HydrochlorideDocetaxelRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesTherapeutics

Study Officials

  • Bonnie S. Glisson, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2005

First Posted

June 8, 2005

Study Start

April 1, 2005

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

February 27, 2012

Record last verified: 2012-02

Locations

US(1)