Back to resultsRAD001 With Weekly Cisplatin and Radiation Therapy in Patients With Locally Advanced Head and Neck Cancer
Primary Purpose
Head and Neck Cancer
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Intensity modulated radiotherapy
RAD001
cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring advanced head and neck cancer, cisplatin, RAD001, radiation, HNSCC
Eligibility Criteria
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
Sites / Locations
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rad001 with cisplatin
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Obtain preliminary results on efficacy of the RAD001, cisplatin and radiation therapy combination in patients with locally advanced HNSCC.
Full Information
NCT ID
NCT01058408
First Posted
January 26, 2010
Last Updated
February 20, 2013
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Novartis
1. Study Identification
Unique Protocol Identification Number
NCT01058408
Brief Title
RAD001 With Weekly Cisplatin and Radiation Therapy in Patients With Locally Advanced Head and Neck Cancer
Official Title
A Phase I Trial Using RAD001 With Weekly Cisplatin and Radiation Therapy in Patients With Locally Advanced Head and Neck Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Novartis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
advanced head and neck cancer, cisplatin, RAD001, radiation, HNSCC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rad001 with cisplatin
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Intensity modulated radiotherapy
Other Intervention Name(s)
IMRT
Intervention Description
Administered daily 5 days per week
Intervention Type
Drug
Intervention Name(s)
RAD001
Intervention Description
Taken orally once a day
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
Administered intravenously once a week
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Obtain preliminary results on efficacy of the RAD001, cisplatin and radiation therapy combination in patients with locally advanced HNSCC.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jochen Lorch, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
RAD001 With Weekly Cisplatin and Radiation Therapy in Patients With Locally Advanced Head and Neck Cancer
We'll reach out to this number within 24 hrs