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Head and Neck Squamous Cell CarcinomaPhase 2NCT01154920

Paclitaxel, Carboplatin and Cetuximab (PCC) With Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) in Previously Untreated Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

A Phase 2 study testing Paclitaxel, Carboplatin and Cetuximab in people with Head and Neck Squamous Cell Carcinoma, run by M.D. Anderson Cancer Center at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical research study is to learn which chemotherapy combination is more effective in treating locally advanced head and neck squamous cell carcinoma. The side effects of these combinations will also be studied. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Paclitaxel, Carboplatin and Cetuximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
2 sitesUnited States
Study dates
9 Jul 2010to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Patients with biopsy-proven squamous cell carcinoma of the oropharynx, oral cavity, nasopharynx, hypopharynx, or larynx.
  • Biopsy material sufficient for HPV status determination available
  • Patients should have stage IV disease, stage T0-4 N2b-2c/3 M0 (for nasopharynx patients, stage N1 is eligible). Measurable disease in either the T or N site by RECIST is required.
  • Patients with stage Tx primary disease are eligible if there is N2b-c/3 lymphadenopathy
  • ECOG PS 0-1
  • Age >/= 18 years
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  • Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC >/= 1500 cells/mm^3 and platelet count >/= 100,000 cells/mm^3; adequate hepatic function with bilirubin </= ULN (excluding Gilbert's disease), AST and ALT may be up to 2.5 x ULN if alkaline phosphatase is normal. Alkaline phosphatase may be up to 4 x ULN if AST and ALT are normal. In determining eligibility the more abnormal of the two values (AST or ALT) should be used.
  • Creatinine clearance >/=40 ml/min determined by 24 hour collection or nomogram:CrCl male = (140 - age) x (wt in kg)/serum Cr x 72 or CrCl female = 0.85 x (CrCl male)
  • Patients should have no serious acute or chronic co-morbid condition, or acute infection, which in the judgment of the attending physician would affect administration of the induction chemotherapy regimens.
  • Patients must sign a study-specific informed consent form

Who cannot join

  • Histology other than squamous cell carcinoma
  • Proven distant metastases (below the clavicle) by clinical or radiographic measures
  • ECOG>1
  • Prior chemotherapy, within the previous 3 years
  • Prior radiotherapy to the head and neck
  • Prior cetuximab therapy or prior therapy with any other drug that targets the EGFR pathway
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  • Initial surgical resection rendering the patient clinically and radiologically disease free
  • Simultaneous primary invasive cancers, excluding superficial non-melanoma skin cancers
  • Patients with a history of another malignancy (excluding non melanoma skin cancers, and cancers treated > 3 years prior for which patient remains continuously disease free
  • Men and women of childbearing potential (WOCBP) unwilling to consent to using effective contraception while on treatment and for at least 3 months thereafter
  • Women who are pregnant or breastfeeding
  • Pre-existing peripheral neuropathy CTCAE Grade 2 or worse
  • Hemoglobin < 8.0g/dL
  • Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 20115

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Randomized Phase II Trial Contrasting Weekly Paclitaxel, Carboplatin and Cetuximab (PCC) With Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) in Previously Untreated Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

The goal of this clinical research study is to learn which chemotherapy combination is more effective in treating locally advanced head and neck squamous cell carcinoma. The side effects of these combinations will also be studied.

Read the detailed description

Treatment on this study consists of 2 parts. The first part of your treatment is called induction chemotherapy and will last for 6-9 weeks, depending on which group you are in. The second part of treatment will be radiation therapy (either with or without chemotherapy). The type of treatment you will receive depends on the site and stage of the disease.

Study Drugs:

Paclitaxel, carboplatin, and 5-fluorouracil are designed to block cancer cells from dividing, which may cause them to die.

Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die. It may also damage blood vessels in tumor tissue.

Cisplatin has a platinum atom at its center. The platinum is supposed to poison the cancer cells, which may cause them to die.

Cetuximab is designed to prevent or slow down the growth of cancer cells by blocking proteins inside the cancer cell, called the epidermal growth factor receptor (EGFR).

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. There is an equal chance of being assigned to either group.

  • If you are in Group A, you will receive cetuximab, paclitaxel, and carboplatin.
  • If you are in Group B, you will receive cetuximab, docetaxel, cisplatin, and 5-fluorouracil.

Part 1 Study Drug Administration:

Group A:

During induction, you will receive cetuximab, paclitaxel, and carboplatin by vein once a week for 6 weeks. During Week 1, the cetuximab infusion will last about 2 hours. During Weeks 2-6, the cetuximab infusion will last about 1 hour. Following the cetuximab infusion, you will receive paclitaxel over about 1 hour followed by carboplatin over about 1 hour.

Your vital signs will be monitored before, during, and after the cetuximab infusion.

Group B:

During induction, you will receive cetuximab, docetaxel, and cisplatin by vein. You will also receive 5-fluorouracil as a non-stop infusion over 4 days through an infusion pump. This pump is portable so that you can have this treatment on an outpatient basis.

On Day 1 of each 21-day cycle:

  • You will receive cetuximab over about 1-2 hours.
  • You will receive docetaxel over about 1 hour.
  • You will receive cisplatin over about 1-3 hours
  • You will then begin receiving 5-fluorouracil. This infusion will be non-stop over the next 4 days.

On Day 2 of each cycle, you will receive saline (salt water) to prevent dehydration.

On Days 5-10 of each cycle, you will take antibiotics, by mouth, to prevent infection. Your doctor will tell you what type of antibiotic to take.

On Day 8 of each cycle, you will receive cetuximab over about 1 hour.

You will have 3 cycles of induction therapy.

Other drugs may be given before you receive the study drugs to prevent side effects. You will be closely monitored for side effects during the infusions in the clinic setting before you will be allowed to leave.

Part 1 Study Visits:

Every week:

  • You will have a physical exam, including measurement of your weight.
  • Blood (about 3 teaspoons) will be drawn for routine tests.
  • You will be asked about any drugs you may be taking.
  • You will be asked about any side effects you may be having.

After you have completed your induction therapy, you will have a CT scan, MRI scan, and/or a PET-CT to check the status of the disease.

Part 2 Study Drug Administration:

Before you begin radiation, you will have a dental exam.

You will begin either radiation with chemotherapy or radiation without chemotherapy. Your doctor will decide which treatment is best for you.

All participants will begin radiation about 2-4 weeks after induction therapy. You will receive radiation Monday through Friday for about 7 weeks, or as recommended by the treating radiologist.

If you are receiving radiation with chemotherapy, you will receive carboplatin or cisplatin every week while you are receiving radiation. If you receive cisplatin, it will be given by vein over about 1-3 hours. If you are given carboplatin, it will be given by vein over about 1 hour.

Part 2 Study Visits:

Every week:

  • You will have a physical exam.
  • Blood (about 3 teaspoons) will be drawn for routine tests.
  • Your skin and the lining of your mouth will be checked for sores.

Follow-Up Phase:

About 6 weeks after you finish all treatments:

  • You will have a physical exam.
  • You will have a chest x-ray.
  • You will be asked about any side effects you may be having.
  • You will be asked about any drugs you are taking.
  • Your skin and the lining of your mouth will be checked for sores.

If you were in Group B, you will have a CT scan, MRI scan, and/or PET/CT scan at 6 weeks (+/- 14 days) after you have completed radiation/chemoradiation to check the status of the disease.

If you were in Group A, you will have a CT scan, MRI scan, and/or PET/CT scan at 9 weeks (+/- 14 days) after you have completed radiation/chemoradiation to check the status of the disease.

Six (6), 12, and 24 months after you finish treatment, you will have a videofluoroscopic to check your swallowing. You will complete a separate consent form for this procedure. You will also complete the questionnaire about your day-to-day activities.

All participants will have clinic visits every 3 months for 2 years. At these visits:

  • You will have a physical exam.
  • You will have a chest x-ray.
  • You will be asked about any side effects you may be having.
  • You will be asked about any drugs you are taking.
  • If your doctor thinks it is needed, you will have additional tests/procedures performed.

After the Year 2, follow up will be done per standard of care. You will be contacted by a member of the study team by phone or by letter and asked about you how you are doing and if you have received any other treatment for cancer.

Length of Study:

You will remain on treatment for about 15-16 weeks. If, during that time, the disease gets worse or you experience intolerable side effects, you will be taken off study.

This is an investigational study. All of the study drugs are FDA approved and commercially available. The combination of these drugs when given to patients with locally advanced head and neck squamous cell carcinoma is investigational.

Up to 128 patients will take part in this multicenter study. Up to 100 will be enrolled MD Anderson.

Keywords
Head and Neck Cancer, HNSCC, Paclitaxel, Carboplatin, Cetuximab, Docetaxel, Taxotere, Cisplatin, Platinol-AQ, Platinol, CDDP, Fluorouracil, 5-FU, Adrucil, Efudex, chemotherapy, radiation, Chemoradiotherapy
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms

What participants receive

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

  • PaclitaxelDrug

    Also called Taxol

    135 mg/m^2 weekly, Weeks 1 - 6

  • CarboplatinDrug

    Also called Paraplatin

    AUC of 2 weekly, Weeks 1 - 6

  • CetuximabDrug

    Also called Erbitux, C225, IMC-C225

    PCC Arm: 400 mg/m^2 by vein over about 1-2 hours on Day 1; 250 mg/m^2 weeks 2 - 6.

    C-TPF Arm: 250 mg/m2 weeks 2, 4, 5, 7 and 8.

  • DocetaxelDrug

    Also called Taxotere

    75 mg/m^2 by vein over 1 hour on Day 1 of each 21 day cycle for 3 cycles of induction therapy

  • CisplatinDrug

    Also called Platinol-AQ, Platinol, CDDP

    100 mg/m^2 by vein over 1-3 hours on Day 1 of each 21 day cycle for 3 cycles of induction therapy

  • FluorouracilDrug

    Also called 5-Fluorouracil, 5-FU, Adrucil, Efudex

    700 mg/m^2 continuous infusion Days 1-4 on Day 1 of each 21 day cycle for 3 cycles of induction therapy

  • Radiotherapy (RT)Radiation

    Also called Radiation Therapy, RT

    Radiation about 2-4 weeks after induction therapy, Monday through Friday for about 7 weeks, or as recommended by the treating radiologist.

  • ChemotherapyOther

    Also called Chemoradiotherapy

    PCC group receives 6 and C-TPF group receives 3 chemotherapy treatment cycles. If receiving radiation + chemotherapy, weekly Cisplatin 40 mg/m^2 by vein over 1-3 hours or Carboplatin AUC 2 by vein over 1 hour beginning 2 to 3 weeks after conclusion of induction program.

Study groups in NCT01154920
Study groupRoleWhat they receive
PCC Group + RTExperimentalGroup A: Paclitaxel, Carboplatin and Cetuximab (PCC) Induction + Radiation (RT)
Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Cetuximab; Radiation: Radiotherapy (RT)
PCC Group + RT + ChemotherapyExperimentalGroup A: Paclitaxel, Carboplatin and Cetuximab (PCC) Induction + Radiation (RT) + Chemotherapy
Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Cetuximab; Radiation: Radiotherapy (RT); Other: Chemotherapy
C-TPF Group + RTExperimentalGroup B: Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) Induction + Radiation (RT)
Receives: Drug: Cetuximab; Drug: Docetaxel; Drug: Cisplatin; Drug: Fluorouracil; Radiation: Radiotherapy (RT)
C-TPF Group + RT + ChemotherapyExperimentalGroup B: Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) Induction + Radiation (RT) + Chemotherapy
Receives: Drug: Cetuximab; Drug: Docetaxel; Drug: Cisplatin; Drug: Fluorouracil; Radiation: Radiotherapy (RT); Other: Chemotherapy

What is being measured

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

  1. Number of Patients with Progression-Free Survival (PFS)

    PFS defined as the time from the first day of treatment until the date of objective progressive disease (PD) (locoregional or distant) or death (by any cause in the absence of PD is first reported.

    Measured: 2 Years

Timeline

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

  1. First posted1 Jul 2010 (estimated)
  2. Study start9 Jul 2010
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

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
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01154920
Sponsor's protocol ID
2009-0885
Other IDs
NCI-2012-01773
Status last verified
Jun 2026
First submitted
29 Jun 2010
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

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

The sponsor lists 10 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. 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 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?

This study is still under way. Results are not available in the source record yet.

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 Patients with Progression-Free Survival (PFS) (time frame: 2 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 NCT01154920.

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 12 Jun 2026.

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