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RAD001 and Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00576680
Recruitment Status : Active, not recruiting
First Posted : December 19, 2007
Last Update Posted : July 24, 2019
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
Novartis
Schering-Plough
Information provided by (Responsible Party):
Jennifer Chan, MD, MPH, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE December 17, 2007
First Posted Date  ICMJE December 19, 2007
Last Update Posted Date July 24, 2019
Study Start Date  ICMJE May 2008
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2007)
To determine the objective response rate of RAD001 in combination with temozolomide in patients with advanced pancreatic neuroendocrine tumors. [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00576680 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2007)
  • To determine the duration of response to the combination of RAD001 and temozolomide in this patient population. [ Time Frame: 2 years ]
  • To determine the safety and tolerability of this drug combination. [ Time Frame: 2 years ]
  • To determine the progression free survival and overall survival of patients receiving this combination. [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RAD001 and Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors
Official Title  ICMJE Phase I/II Study of RAD001 in Combination With Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors
Brief Summary This research study will test the safety of RAD001 in combination with temozolomide.
Detailed Description
  • Participants will take RAD001 by mouth daily. They will also take temozolomide by mouth daily for one week, followed by a one-week break period. This one-week on/one week off schedule for temozolomide will continue for the duration of the treatment.
  • After the first month of treatment, there will be a 7-day observation period during which no study medication will be taken to observe for any side effects.
  • During all treatment cycles (1 cycle is 28 days in length) participants will have a physical exam and will be asked questions about their general health and specific questions about any problems they may be experiencing. Initially, participants will come in every other week. At each of these visits, blood work will be taken to monitor the participants health.
  • After every 2 months of treatment, participants will have a CT scan or MRI done to see how the medication is working.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Neuroendocrine Tumor
Intervention  ICMJE
  • Drug: RAD001
    Given orally once a day
  • Drug: Temozolomide
    Taken orally once a day for one week followed by a one-week break period
    Other Name: Temodar
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 31, 2018)
43
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2007)
12
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Locally unresectable or metastatic pancreatic neuroendocrine tumor
  • Radiologic, operative, or pathology reports should document a pancreatic location of tumor
  • Patients must have confirmed low-grade or intermediate-grade neuroendocrine carcinoma
  • Patients must have at least one measurable site of disease according to RECIST criteria that has not been preciously irradiated
  • 18 years of age or older
  • Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
  • Prior treatment with chemotherapy is allowed, with the exception of prior treatment with temozolomide or dacarbazine
  • No Prior therapy with RAD001 or any other mTOR inhibitor
  • ECOG Performance status 0,1 or 2
  • Life expectancy 12 weeks or more
  • Adequate bone marrow, liver and renal function as outlined in the protocol
  • Negative serum pregnancy test
  • Fasting serum cholesterol as outlined in protocol

Exclusion Criteria:

  • Prior treatment with any investigational drug within the preceding 4 weeks
  • Chronic treatment with systemic steroids or another immunosuppressive agent
  • Patients should not receive immunization with attenuated live vaccines during study period or within 1 week of study entry
  • Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
  • Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
  • Women who are pregnant or breast feeding
  • Patients who have received prior treatment with an mTOR inhibitor or temozolomide
  • Patients with known hypersensitivity to RAD001 or other rapamycins or to its excipients
  • History of noncompliance to medical regimens
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00576680
Other Study ID Numbers  ICMJE 07-325
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jennifer Chan, MD, MPH, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE
  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Massachusetts General Hospital
  • Novartis
  • Schering-Plough
Investigators  ICMJE
Principal Investigator: Jennifer Chan, MD, PhD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP