Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors
The purpose of this study is to find out what effects, good or bad, that thalidomide and temodar have on patients with neuroendocrine tumors...
Brief Summary
Official Title: “A Phase II Study of Thalidomide in Combination With Temodar in Patients With Metastatic Neuroendocrine Tumors”
The purpose of this study is to find out what effects, good or bad, that thalidomide and temodar have on patients with neuroendocrine tumors.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: July 2006
Detailed Clinical Trial Description
- Patients will receive thalidomide orally once daily continuously unless they experience significant side effects. Temodar is given orally once a day for one week, followed by a one week break period. This one week on/one week off schedule will continue for the duration of treatment unless there are significant side effects. - After eight weeks (2 cycles) a CT scan will be performed to see how the treatment has affected the patient's tumor. Patients will continue taking the study drug unless there is evidence of tumor growth. - Regular blood tests will be done weekly during the first two months to make sure that the treatment is not resulting in serious side effects. If there are no side effects during the first two months, the blood tests may decrease in frequency to every two weeks. - Immediately after the patient has completed the study they will be evaluated by physical exam, blood work, and a CT scan. The follow-up will consist of clinic visits and phone calls every 3 months.
Intervention(s) in this Clinical Trial
- Drug: Thalidomide
- Drug: Temodar
Outcome Measures for this Clinical Trial
Primary Measures
- To assess the response rate in patients with locally unresectable neuroendocrine tumors treated with temodar and thalidomide.
Secondary Measures
- To evaluate overall response and progression free survival of this patient population
- to evaluate the safety of temodar and thalidomide.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Histologically confirmed locally unresectable or metastatic neuroendocrine tumor excluding small cell carcinoma
- Prior treatment with chemoembolization or cryotherapy is allowed
- Radiotherapy is allowed if completed more than 4 weeks prior to study.
- Measurable disease as defined by RECIST criteria
- Age greater than or equal to 18 years.
- ECOG performance status of less than or equal to 2
- ANC >1,500/mm3
- Platelet Count > 100,000/mm3
- Hemoglobin > 9 g/dl
- Serum creatinine < 1.5 x ULN
- Total bilirubin < 2 x ULN
- SGOT and SGPT < 2 x ULN
- Alkaline phosphatase < 2 x ULN
- Life expectancy of greater than 12 weeks
Exclusion Criteria:
- Clinically symptomatic central nervous system metastases or carcinomatous meningitis
- Myocardial infarction in past 6 months
- Major surgery in past two weeks
- Uncontrolled serious medical or psychiatric illness
- Insufficient recovery from all active toxicities of prior therapies
- Active nonmalignant systemic disease
- Frequent vomiting or medical condition that could interfere with oral medication intake
- Known HIV positivity or AIDS-related illness
- Pregnant or nursing women
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Dana-Farber Cancer Institute Other
Overall Clinical Trial Officials and Contacts
Matthew H. Kulke, MD Principal Investigator Dana-Farber Cancer Institute
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00165230
Study ID Number: 02-011
ClinicalTrials.gov Identifier: NCT00165230
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00165230
