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

Phase 1
18 Years
Not Enrolling
Head and Neck Cancer

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Trial Information

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

- 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

- 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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Jochen Lorch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

February 2010

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • advanced head and neck cancer
  • cisplatin
  • RAD001
  • radiation
  • Head and Neck Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115