RAD001 With Weekly Cisplatin and Radiation Therapy in Patients With Locally Advanced Head and Neck Cancer

February 20, 2013 updated by: Jochen Lorch, MD, Dana-Farber Cancer Institute

A Phase I Trial Using RAD001 With Weekly Cisplatin and Radiation Therapy in Patients With Locally Advanced Head and Neck Cancer

RAD001 is approved by the U.S Food and Drug Administration (FDA) to treat advanced kidney cancer. This drug has also been used in other research studies to evaluate its effectiveness in other cancers. Information from these research studies suggests that RAD001 may help to decrease the growth and development of tumor cells by reducing the blood supply that tumors need to grow. In this research study, we are trying to determine the safety of RAD001 when given to people with locally advanced head and neck cancer in combination with cisplatin and radiation. We are also looking for the highest dose of RAD001 that can be given to people safely.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

  • Most patients receiving treatment for head and neck cancer will develop difficulty swallowing food and drinking liquids during the course of therapy. For this reason, it will be recommended that a PEG (percutaneous endoscopic gastrostomy) tube be placed in the participants stomach prior to undergoing the study regimen. This is to help maintain weight and nutritional health.
  • Since we are looking for highest dose of the study drug that can be administered safely without severe or unmanageable side effects, not everyone who participates will receive the same dose of RAD001 or cisplatin.
  • The study regimen will last for seven weeks. During each week of study participation the following will occur: Radiation will be administered each weekday (5 days per week). Cisplatin will be given intravenously at the start of each week. RAD001 will be given to the participant to take at home. Participants will take the study drug once a day in the morning starting on day 1.
  • A history and physical exam will be performed weekly while participant's are receiving radiation treatment. Blood tests for routine laboratory testing will be performed weekly.
  • Each month for the first two months after participants finish radiation therapy and stop taking RAD001 and cisplatin, they will have a physical ezam, a neurologic exam, and blood tests. X-rays, a CT, MRI and/or PET scans will also be performed a the two month visit. After the first two months, follow-up will continue every 1-2 months for the first year. Additionally, every 6 months for the first two years, follow-up visits will include an assessment of speech and swallowing functions along with X-rays, CT, MRI and/or PET scans.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with stage III/IV, locally advanced, biopsy proven squamous cell cancer of the head and neck who are planned to undergo chemoradiation as their primary treatment with curative intent. Patients with oropharynx, hypopharynx, larynx primaries, nasopharynx as well as those with documented SCC of the cervical lymph nodes, with unknown primaries, are eligible.
  • Patients must have at least evaluable disease and one measurable site of disease according to RECIST criteria is desirable.
  • 18 years of age or older
  • Minimum of two weeks since any major surgery
  • WHO performance status of 2 or less
  • Adequate bone marrow, liver, and renal function as outlined in the protocol

Exclusion Criteria:

  • Presence of distant metastatic disease
  • Prior chemotherapy
  • Prior radiation to the head and neck or adjacent anatomical site
  • Chronic treatment with systemic steroids or another immunosuppressive agent
  • Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period
  • Other malignancies within the past 3 years except for adequately treated carcinoma of the thyroid, cervix or basal or squamous cell carcinomas of the skin
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
  • Uncontrolled diabetes mellitus
  • A known history of HIV seropositivity
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001
  • Patients with an active, bleeding diathesis or on oral anti-vitamin K medication
  • Women who are pregnant or breastfeeding, or women/men able to conceive and unwilling to practice an effective method of birth control
  • Patients who have received prior treatment with an mTOR inhibitor
  • Patients with a known hypersensitivity to RAD001 or other rapamycins or to its excipients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rad001 with cisplatin
Radiation: Intensity modulated radiotherapy
Administered daily 5 days per week
Other Names:
  • IMRT
Drug: RAD001
Taken orally once a day
Drug: cisplatin
Administered intravenously once a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the maximum tolerated dose (MTD) and safety of the RAD001 in combination with weekly cisplatin and radiation in patients with locally advanced HNSCC.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Obtain preliminary results on efficacy of the RAD001, cisplatin and radiation therapy combination in patients with locally advanced HNSCC.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Novartis
Brigham and Women's Hospital

Investigators

  • Principal Investigator: Jochen Lorch, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

January 26, 2010

First Submitted That Met QC Criteria

January 26, 2010

First Posted (Estimate)

January 28, 2010

Study Record Updates

Last Update Posted (Estimate)

February 22, 2013

Last Update Submitted That Met QC Criteria

February 20, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-342
  • CRAD001C4540T (Other Identifier: Novartis Pharmaceutical)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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