RAD001 and Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors
This study is ongoing, but not recruiting participants.
Sponsor:
Dana-Farber Cancer Institute
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 24, 2013
Last verified: April 2013
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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 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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
- 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
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 24, 2013 |
| 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 Sirolimus Everolimus Temozolomide Dacarbazine Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 16, 2013