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Head and Neck CancerPhase 1/2NCT00851877

Nab-Paclitaxel, Cisplatin, and Cetuximab With Concurrent Radiation Therapy for Locally Advanced Head and Neck Cancer

A Phase 1/2 study testing Cetuximab, Cisplatin and Nab-Paclitaxel in people with Head and Neck Cancer, run by University of Texas Southwestern Medical Center at 2 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, such as paclitaxel albumin-stabilized nanoparticle formulation and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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?
Cetuximab, Cisplatin and Nab-Paclitaxel
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
2 sitesUnited States
Study dates
1 Mar 2009to 3 Aug 2015
Phase
Phase 1/2
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 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma of the oropharynx, hypopharynx, or larynx
  • Diagnosis based on the primary lesion and/or lymph nodes
  • Stage III or IV disease (T2, N2-3, M0 or T3-4, any N, M0)
  • No primary tumor of the oral cavity, nasopharynx, sinuses, or salivary glands
  • No distant metastasis by chest x-ray, CT scan, or PET/CT scan within the past 6 weeks

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • ANC > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Hemoglobin > 9.0 g/dL (transfusion or other intervention to achieve hemoglobin > 8.0 g/dL allowed)
  • Bilirubin ≤ 1.5 mg/dL
  • AST, ALT, and AP ≤ 2.5 times upper limit of normal
  • Serum creatinine ≤ 1.5 mg/dL
  • Creatinine clearance ≥ 50 mL/min
  • None of the following electrolyte abnormalities grade 3-4 by CTCAE v 3.0:
  • Calcium < 7 mg/dL or > 12.5 mg/dL
  • Glucose < 40 mg/dL or > 250 mg/dL
  • Magnesium < 0.9 mg/dL or > 3 mg/dL
  • Potassium < 3 mmol/L or > 6 mmol/L
  • Sodium < 130 mmol/L or > 155 mmol/L
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other prior invasive malignancy, except for nonmelanomatous skin cancer, unless disease-free for ≥ 3 years
  • No prior allergic reaction to study drugs
  • No active cardiac disease, defined as any of the following:
  • Unstable angina
  • Uncontrolled hypertension
  • Myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty)
  • Uncontrolled arrhythmia
  • Congestive heart failure
  • Three or more heart-related hospitalizations within the past year
  • No severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within the past year
  • No AIDS
  • No pre-existing peripheral sensory neuropathy ≥ grade 2
  • No concurrent medical illnesses that would impair patient tolerance to therapy or limit survival

PRIOR CONCURRENT THERAPY:

  • No prior systemic chemotherapy for this cancer
  • Prior systemic chemotherapy for a different cancer allowed
  • No prior radiotherapy to the region of this cancer that would result in overlap of radiotherapy fields
  • No prior initial surgical treatment (excluding diagnostic biopsy of the primary site or nodal sampling of neck disease)
  • At least 48 hours since prior and no concurrent granulocytic growth factors (e.g., filgrastim [G-CSF]) during radiotherapy
  • No concurrent erythropoietic growth factors (e.g., darbepoetin, erythropoietin)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Baylor Research Institute

    Dallas, Texas, 75204

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75239

Other trials in United States

About this study

Official title: A Phase I/II Study of Nab-paclitaxel, Cisplatin and Cetuximab With Concurrent Radiation Therapy for Local-regionally Advanced Head-and-neck Squamous Cell Carcinoma

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Paclitaxel albumin-stabilized nanoparticle formulation may make tumor cells more sensitive to radiation therapy. Giving radiation therapy and paclitaxel albumin-stabilized nanoparticle formulation together with cisplatin and cetuximab may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with cisplatin, cetuximab, and radiation therapy to see how well they work in treating patients with locally advanced stage III or stage IV head and neck cancer.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation when combined with cisplatin, cetuximab, and radiotherapy in patients with local-regionally advanced squamous cell carcinoma of the head and neck. (Phase I)
  • To evaluate the disease-free survival of patients treated with this regimen. (Phase II)

Secondary

  • To identify dose-limiting toxicities in these patients treated with this regimen. (Phase I)
  • To assess the safety and tolerability of this regimen. (Phases I and II)
  • To assess progression-free survival and survival of patients treated with this regimen. (Phase I)
  • To assess overall survival in patients treated with this regimen. (Phase II)
  • To assess response rates in patients treated with this regimen. (Phases I and II)

OUTLINE: This is a multicenter, phase I dose-escalation study of paclitaxel albumin-stabilized nanoparticle formulation followed by a phase II study.

Patients receive cetuximab IV over 120 minutes in week 1. Patients then receive cetuximab IV over 60 minutes, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes, and cisplatin IV over 60 minutes once weekly in weeks 2-8. Patients also undergo 3D conformal or intensity-modulated radiotherapy over 30 minutes on days 1-5 in weeks 2-8.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 4 years.

Being tested
Cetuximab, Cisplatin, Nab-Paclitaxel, intensity-modulated radiation therapy
Keywords
stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, tongue cancer
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Tongue Neoplasms

What participants receive

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

  • CetuximabBiological

    Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor

  • CisplatinDrug

    Also called Platinol

    Cisplatin is an anti-cancer chemotherapy drug

  • Nab-PaclitaxelDrug

    Also called Abraxane

    paclitaxel albumin-stabilized nanoparticle formulation

  • intensity-modulated radiation therapyRadiation

    intensity-modulated radiation therapy

Study groups in NCT00851877
Study groupRoleWhat they receive
arm oneExperimentalNab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy
Receives: Biological: Cetuximab; Drug: Cisplatin; Drug: Nab-Paclitaxel; Radiation: intensity-modulated radiation therapy

What is being measured

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

  1. Phase I Maximum Tolerated Dose of Nab-Paclitaxel

    Seven participants were assigned nab-paclitaxel in dose of 25mg/m^2. Five participants were assigned nab-paclitaxel in dose of 20mg/m^2.

    Measured: 90 days

  2. Phase II 2-year Progression-free Survival

    Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    The primary endpoint of 2-year progression-free survival was measured from the date of enrollment to the first occurrence of new metastatic lesion, objective tumor progression, or death.

    Measured: 2 year

Secondary outcomes (2)

  1. Phase II 2-year Local Control

    Local control is defined as the arrest cancer growth at the site of origin. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions

    Measured: 2 year

  2. Phase II 2-year Overall Survival

    median follow-up 24 months for 34 patients

    Measured: 2 year

Timeline

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

  1. First posted26 Feb 2009 (estimated)
  2. Study start1 Mar 2009
  3. Primary completion1 Oct 2013
  4. Study completion3 Aug 2015

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
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00851877
Sponsor's protocol ID
STU 072010-046
Other IDs
SCCC-112008-019, CDR0000634258
Status last verified
Jul 2018
First submitted
25 Feb 2009
Last updated
21 Aug 2020

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cetuximab, Cisplatin and Nab-Paclitaxel in people with Head and Neck Cancer, run by University of Texas Southwestern Medical Center at 2 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 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 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?

Yes. Results are posted in the registry (first posted 8 Aug 2018). 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?

Phase I Maximum Tolerated Dose of Nab-Paclitaxel (time frame: 90 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 NCT00851877.

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 21 Aug 2020.

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