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Human Papilloma Virus InfectionPhase 2NCT02048020

Paclitaxel and Carboplatin Before Radiation Therapy With Paclitaxel in Treating HPV-Positive Patients With Stage III-IV Oropharynx, Hypopharynx, or Larynx Cancer

A Phase 2 study testing paclitaxel, carboplatin and intensity-modulated radiation therapy in people with Human Papilloma Virus Infection and Stage III Squamous Cell Carcinoma of the Hypopharynx, run by Jonsson Comprehensive 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

This phase II trial studies how well paclitaxel and carboplatin before radiation therapy with paclitaxel works in treating human papillomavirus (HPV)-positive patients with stage III-IV oropharynx, hypopharynx, or larynx cancer. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
paclitaxel, carboplatin and intensity-modulated radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
26 Dec 2013to 9 Jan 2017
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph nodes) diagnosis of HPV-positive squamous cell carcinoma of the oropharynx, hypopharynx, or larynx; HPV-positivity will be defined as tumors that are p16-positive by immunohistochemistry
  • Clinical stage III or IV disease; note: patients with M1 tumors are not eligible
  • Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:
  • History/physical examination within 4 weeks prior to registration, including assessment of weight loss in past 6 months
  • Chest x-ray (or chest computed tomography [CT] scan or positron emission tomography [PET]/CT scan) within 6 weeks prior to registration
  • CT scan or magnetic resonance imaging (MRI) of the head and neck (of the primary tumor and neck nodes) and PET/CT scan
Show all 16Show fewer
  • Zubrod performance status 0-1
  • Absolute neutrophil count (ANC) > 1,800 cells/mm^3
  • Platelets > 100,000 cells/mm^3
  • Hemoglobin (Hgb) > 8.0 g/dl (note: the use of transfusion or other intervention to achieve Hgb > 8.0 g/dl is acceptable)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2x the upper limit of normal
  • Serum creatinine =< 1.5 mg/dl or institutional upper limit of normal
  • Creatinine clearance (CC) >= 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula
  • Negative serum pregnancy test within 7 days prior to start of induction chemotherapy (ICT) for women of childbearing potential
  • Women of childbearing potential and male participants are counseled on birth control and must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study (until at least 60 days following the last study treatment)
  • Patient must sign study specific informed consent prior to study entry

Who cannot join

  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
  • Patients with simultaneous primaries or bilateral tumors are excluded
  • Patients who have had initial surgical treatment other than the diagnostic biopsy of the primary site or nodal sampling of the neck disease are excluded
  • Patients with unknown primary tumor sites are excluded
  • Patients who present with a cervical lymph node metastasis of unknown primary origin
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Show all 19Show fewer
  • Prior radiotherapy that would result in overlap of radiation therapy fields
  • Primary site of tumor of oral cavity, nasopharynx, nasal cavity, paranasal sinuses, or salivary glands
  • Recurrent head and neck cancer
  • Current uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction
  • Congestive heart failure with left ventricular ejection fraction < 20%
  • Transmural myocardial infarction within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • Active lupus erythematosus or scleroderma with ongoing physical manifestations
  • Any uncontrolled condition, which in the opinion of the investigator, would interfere in the safe and timely completion of study procedures
  • Pregnant or lactating women or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Prior allergic reaction to the study drug(s) involved in this protocol
  • Patient is enrolled in another investigational trial

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Phase II Trial Of Induction Chemotherapy Followed By Attenuated Chemoradiotherapy For Locally Advanced Head And Neck Squamous Cell Carcinoma Associated With Human Papillomavirus (HPV)

This phase II trial studies how well paclitaxel and carboplatin before radiation therapy with paclitaxel works in treating human papillomavirus (HPV)-positive patients with stage III-IV oropharynx, hypopharynx, or larynx cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving paclitaxel and carboplatin before radiation therapy with paclitaxel may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the progression-free survival at 2 years in patients with HPV-positive head and neck squamous cell carcinoma (HNSCC) who receive induction chemotherapy followed by dose de-intensified chemoradiotherapy.

SECONDARY OBJECTIVES:

  1. To determine the overall survival and local-regional control for patients with HPV-positive HNSCC who receive induction chemotherapy and dose de-intensified chemoradiotherapy.

II. To determine the incidence of acute grade 3+ mucosal and esophageal toxicity associated with attenuated concurrent chemoradiotherapy in patients with HPV-positive HNSCC.

III. To determine the incidence of late toxicity in patients with HPV-positive HNSCC who receive the dose de-intensified chemoradiotherapy.

IV. To estimate the incidence of all toxicity (hematologic and non-hematologic) associated with protocol treatment for all patients on trial.

  1. To estimate the response rate of HPV-positive to induction chemotherapy using carboplatin and paclitaxel.

VI. To determine the effect of reduced radiation dose on short-term and long-term quality of life among patients treated by chemoradiotherapy.

OUTLINE:

INDUCTION: Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes. Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

CHEMORADIOTHERAPY: At least 2 weeks after completion of induction chemotherapy, patients receive paclitaxel IV over 1 hour weekly and undergo intensity-modulated radiation therapy (IMRT) daily 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 6, 9, and 12 months, every 3 months for 1 year, and then every 6 months for 2 years.

Being tested
paclitaxel, carboplatin, intensity-modulated radiation therapy, quality-of-life assessment
Medical subject headings
Papillomavirus Infections, 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.

  • paclitaxelDrug

    Also called Anzatax, Asotax, TAX, Taxol

    Given IV

  • carboplatinDrug

    Also called Carboplat, CBDCA, JM-8, Paraplat

    Given IV

  • intensity-modulated radiation therapyRadiation

    Also called IMRT

    Undergo IMRT

  • quality-of-life assessmentProcedure or surgery

    Also called quality of life assessment

    Ancillary studies

Study groups in NCT02048020
Study groupRoleWhat they receive
Treatment (paclitaxel, carboplatin, IMRT)ExperimentalINDUCTION: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes. Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. CHEMORADIOTHERAPY: At least 2 weeks after completion of induction chemotherapy, patients receive paclitaxel IV over 1 hour weekly and undergo IMRT daily 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: paclitaxel; Drug: carboplatin; Radiation: intensity-modulated radiation therapy; Procedure: quality-of-life assessment

What is being measured

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

  1. Progression-free survival

    The true 2-year progression-free survival rate will be estimated by the proportion of efficacy-evaluable patients on study without documentation of disease progression or death 2 years from registration. A 95% confidence interval (CI) for the true progression-free survival rate will be constructed using the Duffy-Santner approach. However, Kaplan-Meier methodology will be used to estimate the final 2-year progression-free survival rate and its 95% CI in case there are censored patients.

    Measured: From date of registration to date of first documentation of progression and/or distant metastasis, or death due to any cause, assessed at 2 years

Secondary outcomes (7)

  1. Overall survival

    Time to event distributions will be estimated using the Kaplan-Meier method.

    Measured: The time from registration to death, assessed up to 5 years

  2. Local-regional control

    The 2-year rates of local-regional control will be calculated along with 95% CI for HPV-positive patients receiving the dose de-intensified therapy. It will also be compared with the rate from historical controls using a one-sided Z-test.

    Measured: 2 years

  3. Incidence of mucosal and esophageal >= grade 3 toxicity graded according to the National Cancer Institute Common Terminology for Adverse Events version 4.0 (NCI CTCAE v4.0)

    Rates and 95% CIs of grade 3+ mucosal and esophageal toxicity, late toxicity, other toxicities, protocol treatment delivery (PTD) and death during or within 30 days of discontinuation of protocol treatment will be calculated for the patients receiving the dose de-intensified therapy.

    Measured: Up to 12 weeks after chemoradiotherapy

  4. Incidence of other >= grade 3 toxicity graded according to NCI CTCAE v4.0

    Rates and 95% CIs of grade 3+ mucosal and esophageal toxicity, late toxicity, other toxicities, PTD and death during or within 30 days of discontinuation of protocol treatment will be calculated for the patients receiving the dose de-intensified therapy.

    Measured: Up to 12 weeks after chemoradiotherapy

  5. PTD

    Rates and 95% CIs of grade 3+ mucosal and esophageal toxicity, late toxicity, other toxicities, PTD and death during or within 30 days of discontinuation of protocol treatment will be calculated for the patients receiving the dose de-intensified therapy.

    Measured: Up to 5 years

  6. Incidence of death

    Rates and 95% CIs of grade 3+ mucosal and esophageal toxicity, late toxicity, other toxicities, PTD and death during or within 30 days of discontinuation of protocol treatment will be calculated for the patients receiving the dose de-intensified therapy.

    Measured: During or within 30 days of discontinuation of protocol treatment

  7. Quality of life as assessed by Functional Assessment of Cancer Therapy-Head & Neck (FACT-H&N) and University of Washington Quality of Life (UWQol)

    Descriptive statistics for quality of life measurements will also be obtained, using mean and standard deviation for continuous measures and frequency tables for categorical measures.

    Measured: Up to 5 years

Timeline

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

  1. First posted29 Jan 2014 (estimated)
  2. Study start26 Dec 2013
  3. Primary completion9 Jan 2017
  4. Study completion9 Jan 2017

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
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02048020
Sponsor's protocol ID
13-000915
Other IDs
NCI-2013-02394, 13-000915, P30CA016042
Status last verified
Aug 2018
First submitted
27 Jan 2014
Last updated
14 Aug 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Chen AM, Felix C, Wang PC, Hsu S, Basehart V, Garst J, Beron P, Wong D, Rosove MH, Rao S, Melanson H, Kim E, Palmer D, Qi L, Kelly K, Steinberg ML, Kupelian PA, Daly ME. Reduced-dose radiotherapy for human papillomavirus-associated squamous-cell carcinoma of the oropharynx: a single-arm, phase 2 study. Lancet Oncol. 2017 Jun;18(6):803-811. doi: 10.1016/S1470-2045(17)30246-2. Epub 2017 Apr 20.

    PubMed 28434660

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing paclitaxel, carboplatin and intensity-modulated radiation therapy in people with Human Papilloma Virus Infection and Stage III Squamous Cell Carcinoma of the Hypopharynx, run by Jonsson Comprehensive 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 16 inclusion and 19 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 14 Aug 2018. 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?

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?

Progression-free survival (time frame: From date of registration to date of first documentation of progression and/or distant metastasis, or death due to any cause, assessed at 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 NCT02048020, 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 14 Aug 2018.

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