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AzTrials

Head and Neck CancerPhase 2NCT00301028

Cetuximab, Carboplatin, and Paclitaxel Followed by Radiation Therapy, With or Without Cisplatin, in Treating Patients With Metastatic Head and Neck Cancer

A Phase 2 study testing Cetuximab, Carboplatin and Paclitaxel in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center 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

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
Cetuximab, Carboplatin and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
Apr 2006to Sep 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients with histological proof (from the primary lesion and/or lymph nodes) of squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx.
  • Patients should have stage IV disease, stage T0-4 N2b/2c/3 M0 (for nasopharynx patients, stage N1 disease is eligible). Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) is required.
  • Patients with stage Tx primary disease are eligible if there is N2b/3 adenopathy.
  • Karnofsky performance status of >/= 80 or Eastern Cooperative Oncology Group (ECOG) point scale 0-1
  • Age > 16 years
  • Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of > 1500 cells/mm3 and platelet count of > 100,000 cells/mm3; adequate hepatic function with 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 SGPT and SGOT are normal. Patients who have both SGPT and SGOT > 1.5 ULN and alkaline phosphatase > 2.5 * ULN are not eligible. Normal PT/PTT and normal serum calcium (without intervention) are required.
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  • Creatinine clearance > 40 ml/min determined by 24 hour collection or nomogram: CrCl male = (140 - age) times (weight in kg)/serum Cr times 72 CrCl female = 0.85 times (CrCl male)
  • Patients should have no serious acute or chronic co-morbid condition, or acute infection.
  • Patients must sign a study-specific informed consent form.

Who cannot join

  • Histology other than squamous cell carcinoma.
  • Evidence of distant metastases (below the clavicle) by clinical or radiographic means.
  • Karnofsky performance status < 80 or ECOG>1
  • Prior chemotherapy, within the previous 3 years.
  • Prior radiotherapy to the head and neck.
  • Prior cetuximab therapy, prior therapy with any other drug that targets the EGFR pathway, or prior therapy with a murine or chimeric monoclonal antibody.
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  • Initial surgical resection rendering the patient clinically and radiologically disease free.
  • Simultaneous primary invasive cancers.
  • Patients with another malignancy (excluding non melanoma skin cancers, and cancers treated > 3 years prior for which patient remains continuously disease free).
  • Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. Subjects who are men must also agree to use effective contraception. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin (HCG)) within 72 hours prior to the start of study medication.
  • WOCBP using a prohibited contraceptive method.
  • Women who are pregnant or breastfeeding.
  • Women with a positive pregnancy test on enrollment or prior to study drug administration.
  • Refusal to sign the informed consent.
  • Pre-existing peripheral neuropathy Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or worse.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M.D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

Other trials in United States

About this study

Official title: Phase II Trial of Induction Therapy With Cetuximab (C225) and Carboplatin/Paclitaxel Chemotherapy in Previously Untreated Patients With Advanced (Stage IV) Head & Neck Squamous Cell Carcinoma

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin, paclitaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving cetuximab together with combination chemotherapy and radiation therapy, with or without cisplatin, may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with carboplatin and paclitaxel followed by radiation therapy, with or without cisplatin, works in treating patients with metastatic head and neck cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the increase in clinical/radiographic complete response rate in patients with previously untreated metastatic squamous cell carcinoma of the head and neck treated with induction therapy comprising cetuximab, carboplatin, and paclitaxel.
  • Determine the toxic effects of this regimen in these patients.

Secondary

  • Determine the pattern of tumor recurrence in patients treated with this regimen.
  • Determine the quality of life of patients treated with this regimen.
  • Determine the duration of response, time to progression, and survival of patients treated with this regimen.
  • Correlate effects of this regimen with biomarkers of response and predictors of long-term outcome in these patients.

OUTLINE: This is a nonrandomized, open-label study.

Patients receive induction therapy comprising cetuximab IV over 1-2 hours, paclitaxel IV over 1 hour, and carboplatin IV over 1 hour on day 1. Treatment repeats weekly for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 2-3 weeks later, patients undergo radiotherapy or chemoradiotherapy. Patients with T0, 1, 2 disease undergo radiotherapy 5 days a week for 6 weeks. Patients with T3, 4 disease or unresectable nodal disease undergo radiotherapy 5 days a week for 6 weeks and receive concurrent cisplatin IV over 1-2 hours on days 1 and 22. Some patients may undergo primary surgical resection before or instead of radiotherapy or chemoradiotherapy.

Quality of life is assessed at baseline and at 6, 12, and 24 months after completion of radiotherapy or surgery.

After study completion, patients are followed every 3 months for 2 years, every 4 months for 1 year, and every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Being tested
Cetuximab, Carboplatin, Paclitaxel, Conventional Surgery, Radiation Therapy
Keywords
stage IV squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the lip and oral cavity
Medical subject headings
Head and Neck 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.

  • CetuximabBiological

    Also called C225, Erbitux, IMC-C225

    Beginning weekly dose 400 mg/m^2 IV over 1-2 hours, and 250 mg/m^2 weeks 2-6.

  • CarboplatinDrug

    Also called Paraplatin

    AUC 2 weekly for 6 courses.

  • PaclitaxelDrug

    Also called Taxol

    135 mg/m^2 weekly for 6 courses.

  • Conventional SurgeryProcedure or surgery

    Following induction in second part of study.

  • Radiation TherapyRadiation

    Also called Radiotherapy, RT, XRT

    Following induction in second part of study.

Study groups in NCT00301028
Study groupRoleWhat they receive
Cetuximab + Carboplatin/PaclitaxelExperimentalCetuximab beginning weekly dose 400 mg/m^2 intravenous (IV), and 250 mg/m^2 weeks 2-6; Weekly Carboplatin area under the curve (AUC) 2 and Paclitaxel 135 mg/m^2 for 6 courses.
Receives: Biological: Cetuximab; Drug: Carboplatin; Drug: Paclitaxel; Procedure: Conventional Surgery; Radiation: Radiation Therapy

What is being measured

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

  1. Number of Participants With Complete Response

    Number of participants with a complete response. Complete Response (CR): Disappearance of clinical and radiological evidence of tumor.

    Measured: Study period of 3 Years

Timeline

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

  1. First posted10 Mar 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionSep 2011
  4. Study completionSep 2011

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00301028
Sponsor's protocol ID
2003-0919
Other IDs
P50CA097007, P30CA016672, MDA-2003-0919, BMS-CA225054, CDR0000441273
Status last verified
Feb 2013
First submitted
8 Mar 2006
Last updated
5 Apr 2013
Data monitoring committee
No

Publications

  • Kies MS, Holsinger FC, Lee JJ, William WN Jr, Glisson BS, Lin HY, Lewin JS, Ginsberg LE, Gillaspy KA, Massarelli E, Byers L, Lippman SM, Hong WK, El-Naggar AK, Garden AS, Papadimitrakopoulou V. Induction chemotherapy and cetuximab for locally advanced squamous cell carcinoma of the head and neck: results from a phase II prospective trial. J Clin Oncol. 2010 Jan 1;28(1):8-14. doi: 10.1200/JCO.2009.23.0425. Epub 2009 Nov 16.

    PubMed 19917840

  • Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.

    PubMed 25057165

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cetuximab, Carboplatin and Paclitaxel in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center 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 9 inclusion and 15 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 5 Apr 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 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?

Yes. Results are posted in the registry (first posted 5 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Complete Response (time frame: Study period of 3 Years). 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 NCT00301028, which also lists 2 linked publications.

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 5 Apr 2013.

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