RAD001 and Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors

This study is ongoing, but not recruiting participants.
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
ClinicalTrials.gov Identifier:
NCT00576680
First received: December 17, 2007
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

This research study will test the safety of RAD001 in combination with temozolomide.


Condition Intervention Phase
Pancreatic Neuroendocrine Tumor
Drug: RAD001
Drug: Temozolomide
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of RAD001 in Combination With Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine the objective response rate of RAD001 in combination with temozolomide in patients with advanced pancreatic neuroendocrine tumors. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the duration of response to the combination of RAD001 and temozolomide in this patient population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To determine the safety and tolerability of this drug combination. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To determine the progression free survival and overall survival of patients receiving this combination. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: May 2008
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576680

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
Novartis
Schering-Plough
Investigators
Principal Investigator: Jennifer Chan, MD, PhD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Jennifer Chan, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00576680     History of Changes
Other Study ID Numbers: 07-325
Study First Received: December 17, 2007
Last Updated: April 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
RAD001
temozolomide

Additional relevant MeSH terms:
Neuroendocrine Tumors
Adenoma, Islet Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenoma
Neoplasms, Glandular and Epithelial
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Temozolomide
Dacarbazine
Sirolimus
Everolimus
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents

ClinicalTrials.gov processed this record on September 18, 2014