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HEAD & NECK CancerPhase 1NCT00935961

RAD001 (Everolimus) + Docetaxel + Cisplatin as Induction Chemotherapy in Patients With Local-Regional Advanced Head and Neck Cancer

A Phase 1 study testing RAD001 + docetaxel + cisplatin in people with HEAD & NECK Cancer, run by Memorial Sloan Kettering Cancer Center at 5 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

The purpose of this study is to test the safety of RAD001 (everolimus) tablets at different dose levels, when added to docetaxel and cisplatin. The investigators want to find out what effects, good and/or bad, that everolimus has when added to docetaxel and cisplatin as treatment for head and neck cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HEAD & NECK Cancer
What is being tested?
RAD001 + docetaxel + cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
5 sitesUnited States
Study dates
Jul 2009to Aug 2013
Phase
Phase 1
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Stage III-IVB head and neck squamous cell carcinoma (HNSCC) or nasopharyngeal cancer (WHO type I, II or III),, previously untreated. Patients with stage II hypopharynx HNSCC will also be eligible. Pathology must be confirmed at MSKCC
  • Age ≥ 18 years
  • Karnofsky performance status ≥ 70%
  • Adequate bone marrow function: Absolute neutrophil count ≥ 1.5 X 109/L, Platelets ≥ 100 x 109/L, Hemoglobin > 10 g/dL.
  • Adequate liver function Serum bilirubin must be within the upper limit of normal. (ULN). AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility
  • Adequate renal function: serum creatinine within institutional normal limits, or calculated creatinine clearance (by Cockcroft and Gault method) ≥ 55 mL/min for patients with creatinine limits above institutional normal
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  • INR < 1.5 or aPTT < 1.5 X upper limits of normal
  • Negative urine or serum pregnancy test within 14 days prior to administration of RAD001
  • Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
  • Patients must have ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Any prior treatment with RAD001, or other agents specifically targeting mTOR
  • Any prior radiation therapy for head and neck cancer. Any prior radiation therapy to >25% of the bone marrow. Any prior radiation to whole pelvis and/or brain
  • Therapeutic anticoagulation with coumadin (warfarin)
  • Hypertriglyceridemia ≥ grade 2 (CTCAE version 3.0)
  • Patients who require chronic treatment with steroids ( > prednisone 5 mg/day) or other immunosuppressive agents are excluded. Both cisplatin and RAD001 are immunosuppressive, and chronic steroid use (> prednisone 5 mg/day) or use of other immunosuppressive agents might increase the risk of lethal infection in this setting. Patients on low- dose steroid replacement regimens (≤ prednisone 5 mg/day) are not excluded, because low dose steroids should not be immunosuppressive
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
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  • Active infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatment. Other concurrent severe and/or uncontrolled medical disease which would compromise participation in the study in the opinion of the investigator (e.g., uncontrolled diabetes, unstable angina, or congestive heart failure - New York Heart Association Class III or IV)
  • HIV-positive patients. These patients are at increased risk of lethal infections when treated with marrow suppressive therapy. Additionally, pharmacokinetic interactions between antiretroviral therapy and the study regimen may be problematic for these patients
  • Women who are pregnant or lactating
  • Other active malignancy, other than indolent malignancies which the investigator determines are unlikely to interfere with treatment and safety analysis. For example, patients with non-melanoma skin cancer, in situ carcinoma of the cervix, or prostate cancer with no current biochemical (PSA) or radiologic evidence of disease may enroll
  • Patients with hearing loss requiring hearing aid or intervention (i.e. interfering in a clinical significant way with activities of daily living).
  • Patients with multifocal peripheral sensory alterations or paresthesias (including tingling) interfering with function, per patient report (example: activities of daily living)
  • Impaired lung function: O2 saturation 88% or less at rest on room air by Pulse Oximetry. If O2 saturation is ≤ 88% at rest, further pulmonary function tests (PFTs) should be ordered to confirm normal pulmonary function and eligibility
  • Patients should not receive immunization with attenuated live vaccines within one week of study entry or during the study period. Close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines
  • Liver disease such as cirrhosis or severe hepatic impairment (Childs-Pugh class C)

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Memorial Sloan-Kettering Cancer Center at Basking Ridge

    Basking Ridge, New Jersey, 07939

  • Memorial Sloan-Kettering Cancer Center at Commack

    Commack, New York, 11725

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan-Kettering at Mercy Medical Center

    Rockville Centre, New York

  • Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center

    Sleepy Hollow, New York, 10591

Other trials in United States

About this study

Official title: A Phase I Study of RAD001 (Everolimus) + Docetaxel + Cisplatin as Induction Chemotherapy in Patients With Local-Regional Advanced Head and Neck Cancer

The purpose of this study is to test the safety of RAD001 (everolimus) tablets at different dose levels, when added to docetaxel and cisplatin. The investigators want to find out what effects, good and/or bad, that everolimus has when added to docetaxel and cisplatin as treatment for head and neck cancer.

Being tested
RAD001 + docetaxel + cisplatin
Keywords
CISPLATIN, RAD001, TAXOTERE (DOCETAXEL), 09-028, Squamous Cell Carcinoma, Local-Regional Advanced Head and Neck
Medical subject headings
Head and Neck Neoplasms, Carcinoma, Squamous Cell

What participants receive

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

  • RAD001 + docetaxel + cisplatinDrug

    Patients will receive daily RAD001 (everolimus, per dose escalation scheme) plus concurrent docetaxel (75 mg/m2 intravenously every 3 weeks) + cisplatin (75 mg/m2 intravenously every 3 weeks). Pegfilgrastim (6 mg/subcutaneously) will be administered on day 2 of each cycle. Patients will be followed for toxicity for 30 days after the last dose of RAD001. Patients should undergo re-staging imaging studies within 2 - 6 weeks after the final treatment with cisplatin/docetaxel. After the completion of induction chemotherapy and the 30-day observation period after treatment, patients are removed from the study.

Study groups in NCT00935961
Study groupRoleWhat they receive
RAD001 + docetaxel + cisplatinExperimentalIn this phase I trial, the primary endpoint will be considered to be reached when we have described a phase II recommended dose of RAD001 given with docetaxel + cisplatin as induction chemotherapy for head and neck cancer. Up to 3 dose levels of daily RAD001 will be studied. A standard 3 + 3 phase I dose escalation design will be used. The phase II recommended dose will be determined according to the dose escalation plan.
Receives: Drug: RAD001 + docetaxel + cisplatin

What is being measured

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

  1. To determine the phase II recommended dose of RAD001 (everolimus) + docetaxel + cisplatin as induction chemotherapy for patients with head and neck cancer

    Measured: 2 years

Secondary outcomes (2)

  1. To establish the safety and tolerability of RAD001 (everolimus) + docetaxel + cisplatin

    Measured: 2 years

  2. To determine the objective response rate of all patients treated with RAD001 (everolimus) + docetaxel + cisplatin using RECIST criteria

    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 posted9 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionAug 2013
  4. Study completionAug 2013

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00935961
Sponsor's protocol ID
09-028
Status last verified
Aug 2013
First submitted
7 Jul 2009
Last updated
9 Aug 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RAD001 + docetaxel + cisplatin in people with HEAD & NECK Cancer, run by Memorial Sloan Kettering Cancer Center at 5 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 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 9 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 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.

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?

To determine the phase II recommended dose of RAD001 (everolimus) + docetaxel + cisplatin as induction chemotherapy for patients with head and neck cancer (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 NCT00935961.

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 9 Aug 2013.

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