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Squamous Cell CarcinomaPhase 2NCT00176254

Paclitaxel, Carboplatin and Radiotherapy as Induction Therapy in Locally Advanced Head and Neck Cancer

A Phase 2 study testing Radiotherapy, Paclitaxel and Carboplatin in people with Squamous Cell Carcinoma, run by Susanne Arnold.

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 study utilizes two cycles of Paclitaxel and Carboplatin chemotherapies followed by four small doses of radiation, prior to other treatment (surgery or radiation). This study is evaluating if radiation as a chemoenhancer increases the response rate of initial therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Carcinoma
What is being tested?
Radiotherapy, Paclitaxel and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
May 2000to Oct 2012
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients greater than 18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
  • Patients with pathologically documented bulky T2, III and IV squamous cell cancer of the head and neck (excluding M1 disease), within 2 months of diagnosis. Bulky T2 tumors are defined as those that have a volume of disease greater than 35 cm3 as measured by CT or MRI scan (26).
  • Patients will be medically fit for undergoing chemotherapy. Specifically:
  • no evidence of active angina pectoris or ventricular arrhythmias; no myocardial infarction within the last six months. (Patients with medically controlled hypertension or congestive heart failure are eligible.)
  • an absolute neutrophil count of > 1000/uL and platelet count > 100,000/microliter (uL)
Show all 13Show fewer
  • serum total bilirubin < 1.5 mg/dL
  • Creatinine Clearance greater than 50 ml/min
  • Using an actual or calculated creatinine clearance using the formula:
  • (140 - age) x (wgt in kg)/(serum creatinine)x(72)= multiply by 0.85 for females
  • if a pre-existing grade I neuropathy exists, patients must be willing to risk worsening neuropathy secondary to Paclitaxel. Patients with grade II or greater neuropathy will be excluded from study.
  • ability to give written, informed consent to participate in the trial.
  • Patients will have measurable disease as determined by MRI or CT scan or evaluable disease determined by panendoscopy to be eligible for enrollment on this study.

Who cannot join

  • Pregnant females. Males and women of childbearing potential must use effective contraception in order to prevent pregnancy during therapy.
  • Patients with a history of previous or current malignancy at other sites diagnosed within the last 5 years, with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain free of recurrence or metastases for greater than five years are eligible.
  • Patients with active infection will not be eligible for this protocol until the infection is treated and the symptoms have clinically resolved.
  • Patients with a history of allergy to drugs utilizing Cremophor in the formulation.
  • Prior induction chemotherapy, prior irradiation or surgery will not be allowed.
  • Patients with metastatic disease will not be eligible for this study.
  • Patients with grade II or greater peripheral neuropathy will be excluded from study.

About this study

This study utilizes two cycles of Paclitaxel and Carboplatin chemotherapies followed by four small doses of radiation, prior to other treatment (surgery or radiation). This study is evaluating if radiation as a chemoenhancer increases the response rate of initial therapy.

Read the detailed description

Cancers of the head and neck (H\&N) comprise 5% of all cancers, with 40,000 new cases diagnosed annually. Surgery followed by irradiation or irradiation alone has been the standard of care for locally advanced Stage III and IV patients. With this approach, fewer than 30% of patients achieve long-term remission, and most recur locoregionally. Neoadjuvant chemotherapy has been administered prior to definitive therapy with response rates ranging from 60-90%; with pathologic complete response (CR) rates documented in 30-70% of clinical responders. However, large randomized trials have shown no improvement in overall survival.

Because induction chemotherapy alone does not appear to improve long-term disease free survival in advanced head and neck cancers, concomitant chemotherapy and radiation has been pursued in patients with locally advanced head and neck cancers. Improved disease-free survival has been demonstrated with a variety of agents. The concept of synergy between radiation and chemotherapy is well established in vitro. Various schedules of radiation and chemotherapy have been utilized including weekly chemotherapy during radiation, chemotherapy given every three weeks during hyperfractionated radiation and alternating chemotherapy and radiation.

One exciting new chemotherapeutic agent, Paclitaxel has been shown to radiosensitize cancer cell lines in vitro. Recent studies have added Carboplatin to Paclitaxel in tandem or concurrently with radiation in hopes of improving response rates. From in-vitro data, it appears that the optimum schedule for the combination of Paclitaxel and radiation is to first induce G2/M arrest with Paclitaxel and follow this with radiation therapy. In a recent study by Chendil, et al, a novel radiation scheme appeared to enhance the response of both p53 wild type and p53 mutant cancer cell lines to chemotherapy. In vitro data with Carboplatin also indicates an additive effect when given prior to irradiation using various cell lines. What has not been evaluated, is whether a neoadjuvant regimen of Paclitaxel and Carboplatin followed by 4 small fractions of radiation can be given safely and effect an improved response rate in patients with bulky T2, Stage III and IV H\&N cancer. We propose the use of two cycles of Paclitaxel and Carboplatin followed by four small fractions of radiation, prior to definitive treatment (surgery or radiation). It is hoped that using radiation as a chemoenhancer will increase the response rate to induction therapy in this population of patients.

Being tested
Radiotherapy, Paclitaxel, Carboplatin
Keywords
head and neck, squamous cell carcinoma, squamous cell, carcinoma, paclitaxel, carboplatin, radiotherapy, induction therapy
Medical subject headings
Carcinoma, Squamous Cell, Carcinoma

What participants receive

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

  • RadiotherapyRadiation

    80 centigray (cGy) on Day 1 \& 2 and 22 \& 23 of chemotherapy

  • PaclitaxelDrug

    Also called Taxol

    225 mg/m2 intravenously over three hours on Days 1 and 22

  • CarboplatinDrug

    Also called Paraplatin, CBDCA

    Area under the curve (AUC) of 6 will be given intravenously over 30 minutes on days 1 and 22

Study groups in NCT00176254
Study groupRoleWhat they receive
Induction chemotherapy and radiationExperimentalInduction chemotherapy with low dose radiation
Receives: Radiation: Radiotherapy; Drug: Paclitaxel; Drug: Carboplatin

What is being measured

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

  1. Response Rate to Induction Chemotherapy Prior to Definitive Therapy (Surgery or Radiation)

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

    Measured: assessed pre-study and once between days 36-57

Secondary outcomes (4)

  1. Frequency of Severe (>/= Grade 3) Toxicities

    Measured: assessed starting on day 1 through study day 58 or until toxicity resolves

  2. 5 Year Overall Survival Rates

    Measured: 5 years post study

  3. 5 Year Disease-specific Survival

    Outcome is calculated from the time of enrollment to the time of death due to disease under study or survival to 5 years without death from disease under study, whichever occurs first.The 5-year rates of disease-specific survival were calculated using the Kaplan-Meier method.

    Measured: 5 years

  4. 5 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

    Measured: 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 posted15 Sep 2005 (estimated)
  2. Study startMay 2000
  3. Primary completionOct 2012
  4. Study completionOct 2012

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00176254
Sponsor's protocol ID
00-H&N-11-BMS
Status last verified
Apr 2023
First submitted
9 Sep 2005
Last updated
16 May 2023
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiotherapy, Paclitaxel and Carboplatin in people with Squamous Cell Carcinoma, run by Susanne Arnold.

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 13 inclusion and 7 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 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.

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 23 Jan 2014). 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?

Response Rate to Induction Chemotherapy Prior to Definitive Therapy (Surgery or Radiation) (time frame: assessed pre-study and once between days 36-57). 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 NCT00176254.

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 16 May 2023.

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