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Recurrent Salivary Gland CancerPhase 1/2NCT00055770

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

A Phase 1/2 study testing erlotinib hydrochloride, docetaxel and laboratory biomarker analysis in people with Recurrent Salivary Gland Cancer and Recurrent Squamous Cell Carcinoma of the Hypopharynx, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
erlotinib hydrochloride, docetaxel and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteUnited States
Study dates
Oct 2002to Dec 2006
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 49Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: 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.

Read the detailed description

OBJECTIVES:

  1. 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.

Being tested
erlotinib hydrochloride, docetaxel, laboratory biomarker analysis, pharmacological study
Medical subject headings
Salivary Gland Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • erlotinib hydrochlorideDrug

    Also called CP-358,774, erlotinib, OSI-774

    Given orally

  • docetaxelDrug

    Also called RP 56976, Taxotere, TXT

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

Study groups in NCT00055770
Study groupRoleWhat they receive
Arm IExperimentalPHASE 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.
Receives: Drug: erlotinib hydrochloride; Drug: docetaxel; Other: laboratory biomarker analysis; Other: pharmacological study

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 28 days

  2. Proportion of patients with an objective response (Phase II)

    Measured: Up to 6 years

Secondary outcomes (3)

  1. Response rate as measured by RECIST criteria (Phase II)

    Measured: Up to 6 years

  2. Time to tumor progression (Phase II)

    Measured: Up to 6 years

  3. Median survival (Phase II)

    Measured: Up to 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2003 (estimated)
  2. Study startOct 2002
  3. Primary completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00055770
Sponsor's protocol ID
NCI-2012-01432
Other IDs
NCI-2012-01432, OSU-0213, NCI-5393, CDR0000271197, OSU-02H0084, OSU 0213, 5393, U01CA076576
Status last verified
Nov 2013
First submitted
6 Mar 2003
Last updated
25 Nov 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing erlotinib hydrochloride, docetaxel and laboratory biomarker analysis in people with Recurrent Salivary Gland Cancer and Recurrent Squamous Cell Carcinoma of the Hypopharynx, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 49 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00055770.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.

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