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Head and Neck CancerPhase 2NCT00040807

Irinotecan and Docetaxel in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer

A Phase 2 study testing docetaxel and irinotecan hydrochloride in people with Head and Neck Cancer, run by Eastern Cooperative Oncology Group at 43 sites 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

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of irinotecan and docetaxel in treating patients who have metastatic or locally recurrent… Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Head and Neck Cancer
What is being tested?
docetaxel and irinotecan hydrochloride
How many people
Not given
Where
43 sitesUnited States
Study dates
19 Nov 2002to 1 May 2009
Phase
Phase 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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed carcinoma of the head and neck
  • Squamous cell carcinoma
  • No WHO grade II or III nasopharyngeal carcinoma (well-differentiated nasopharyngeal carcinoma allowed)
  • Metastatic or locally recurrent disease considered to be incurable by locoregional therapy
  • Unidimensionally measurable disease outside previously irradiated field unless documented progressive disease or histologically confirmed residual carcinoma at least 8 weeks after completion of radiotherapy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin normal
  • AST and ALT less than 2.5 times upper limit of normal (ULN) and alkaline phosphatase normal OR
  • Alkaline phosphatase less than 4 times ULN and AST and ALT normal

Renal:

  • Creatinine less than 2.0 mg/dL

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No active infection
  • No pre-existing grade 2 or greater peripheral neuropathy
  • No other concurrent medical condition that would preclude study participation
  • No hypersensitivity to drugs formulated with Polysorbate 80
  • No other malignancy within the past 3 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 2 weeks since prior biologic therapy
  • Any number of prior biologic therapies (e.g., chimeric antibodies or kinase inhibitors) allowed
  • No concurrent filgrastim (G-CSF)

Chemotherapy:

  • At least 4 weeks since prior chemotherapy
  • No prior docetaxel or irinotecan
  • No more than 1 prior chemotherapy regimen for recurrent or metastatic disease

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy for recurrent or metastatic disease and recovered

Surgery:

  • Recovered from prior surgery

Other:

  • No concurrent antiepileptics
  • No concurrent cyclosporine

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

United States43 sites

  • Medical Center of Aurora - South Campus

    Aurora, Colorado, 80012-0000

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294-3300

  • Tufts - New England Medical Center

    Boston, Massachusetts, 02111

  • Boulder Community Hospital

    Boulder, Colorado, 80301-9019

  • CCOP - Cedar Rapids Oncology Project

    Cedar Rapids, Iowa, 52403-1206

  • Veterans Affairs Medical Center - Lakeside Chicago

    Chicago, Illinois, 60611-4494

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611

  • Penrose Cancer Center

    Colorado Springs, Colorado, 80933

  • Veterans Affairs Medical Center - Atlanta (Decatur)

    Decatur, Georgia, 30033

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • St. Joseph Hospital

    Denver, Colorado, 80218-1191

  • Presbyterian - St. Luke's Medical Center

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers - Denver Rose

    Denver, Colorado, 80220

  • CCOP - Colorado Cancer Research Program, Incorporated

    Denver, Colorado, 80224

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309-1016

  • Swedish Medical Center

    Englewood, Colorado, 80112

  • CCOP - Evanston

    Evanston, Illinois, 60201

  • CCOP - St. Vincent Hospital Cancer Center, Green Bay

    Green Bay, Wisconsin, 54307-3453

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Hope Cancer Care Center at Longmont United Hospital

    Longmont, Colorado, 80501

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-0001

  • CCOP - Marshfield Clinic Research Foundation

    Marshfield, Wisconsin, 54449

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226-3596

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615-7828

  • St. Mary-Corwin Regional Medical Center

    Pueblo, Colorado, 81004

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • CCOP - Sioux Community Cancer Consortium

    Sioux Falls, South Dakota, 57104

  • Stanford Cancer Center at Stanford University Medical Center

    Stanford, California, 94305-5216

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9497

  • Albert Einstein Clinical Cancer Center

    The Bronx, New York, 10461

  • MBCCOP-Our Lady of Mercy Cancer Center

    The Bronx, New York, 10466

  • Rocky Mountain Cancer Centers - Thornton

    Thornton, Colorado, 80221

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43623-3456

  • CCOP - Oklahoma

    Tulsa, Oklahoma, 74136

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

Other trials in United States

About this study

Official title: Phase II Trial Of Weekly Irinotecan And Docetaxel In Recurrent Or Metastatic Head And Neck Carcinoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of irinotecan and docetaxel in treating patients who have metastatic or locally recurrent head and neck cancer.

Read the detailed description

OBJECTIVES:

  • Determine the response rate in patients with metastatic or locally recurrent head and neck cancer treated with irinotecan and docetaxel.
  • Determine the progression-free and overall survival of patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.
  • Correlate angiogenesis markers and cyclooxygenase-2 expression with response and survival in patients treated with this regimen.
  • Correlate UGT1A1 genotype with the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (no prior chemotherapy for locally recurrent or metastatic disease or more than 6 months since prior chemotherapy as primary therapy vs 1 prior chemotherapy regimen for locally recurrent or metastatic disease or less than 6 months since prior chemotherapy as primary therapy).

Patients receive docetaxel IV over 60 minutes followed by irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 32-72 patients (16-36 per stratum) will be accrued for this study within 6-14 months.

Keywords
recurrent metastatic squamous neck cancer with occult primary, metastatic squamous neck cancer with occult primary squamous cell carcinoma, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent salivary gland cancer, salivary gland squamous cell carcinoma, stage IV salivary gland cancer
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Salivary Gland Neoplasms

What participants receive

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

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study start19 Nov 2002
  3. Primary completionApr 2005
  4. Study completion1 May 2009

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 2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00040807
Sponsor's protocol ID
CDR0000069408
Other IDs
ECOG-E3301
Status last verified
Jun 2023
First submitted
8 Jul 2002
Last updated
18 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Argiris A, Buchanan A, Brockstein B, Kolesar J, Ghebremichael M, Pins M, Hahn K, Axelrod R, Forastiere A. Docetaxel and irinotecan in recurrent or metastatic head and neck cancer: a phase 2 trial of the Eastern Cooperative Oncology Group. Cancer. 2009 Oct 1;115(19):4504-13. doi: 10.1002/cncr.24528.

    PubMed 19634157

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing docetaxel and irinotecan hydrochloride in people with Head and Neck Cancer, run by Eastern Cooperative Oncology Group at 43 sites 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?

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 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites 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 phase mean?

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00040807, which also lists 1 linked publication.

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 18 Jun 2023.

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