Bevacizumab in Combination With Temozolomide in Patients With Neuroendocrine Tumors
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| ClinicalTrials.gov Identifier: NCT00137774 |
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Recruitment Status :
Completed
First Posted : August 30, 2005
Last Update Posted : April 9, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neuroendocrine Tumors | Drug: Bevacizumab Drug: Temozolomide | Phase 2 |
Patients will receive temozolomide orally once daily for one week, followed by a one-week rest period. This one-week on/one week off schedule will continue for the duration of treatment unless significant side effects develop.
Bevacizumab will be administered intravenously every other week. After eight weeks (two cycles), a CT scan will be performed to see how treatment affected tumor growth.
Bactrim, an antibiotic, and acyclovir, an antiviral medicine, will be given in order to help prevent infection.
Blood tests will be done every other week to evaluate any side effects.
Once the study has been completed, a physical exam, vital signs, blood tests, and CT scan will be performed.
Patients will remain on the study as long as they continue to receive benefit from the treatment and there are no serious side effects.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 34 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Study of Bevacizumab in Combination With Temozolomide in Patients With Advanced Neuroendocrine Tumors |
| Study Start Date : | November 2004 |
| Actual Primary Completion Date : | July 2005 |
| Actual Study Completion Date : | December 2012 |
- Drug: Bevacizumab
Given intravenously every other week. Participants can continue to receive study drug as long as there is no disease progression or serious side effects.
- Drug: Temozolomide
Given once daily for one week followed by a one week rest period. This one-week on/one-week off scheduled will be continued as long as there is no disease progression or serious side effects.
- To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors [ Time Frame: 2 years ]
- To assess the time to progression, progression free survival and safety of bevacizumab in combination with temozolomide in this patient population
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically documented locally unresectable or metastatic neuroendocrine tumor excluding small cell carcinoma
- Measurable disease > 1cm by spiral computed tomography (CT) or > 2cm by other radiographic technique
- ECOG performance status of 0-2
- Life expectancy of > 12 weeks
- Prior treatment with chemotherapy is allowed
- Total bilirubin < 2.0mg/dl
- AST < 5x upper limit of normal (ULN)
- Serum creatinine < 2.0mg/dl
- Absolute neutrophil count > 1,000/mm3
- Platelets > 100,000/mm3
- International Normalized Ratio (INR) < 1.5
Exclusion Criteria:
- Prior treatment with temozolomide, decarbazine or bevacizumab
- Clinically apparent central nervous system metastases or carcinomatous meningitis
- Clinically significant cardiovascular disease
- Major surgery, open biopsy, or significant traumatic injury within 28 days
- Pregnant or breast-feeding women
- Chronic, daily treatment with aspirin or nonsteroidal anti-inflammatory medication
- Serious, nonhealing wound, ulcer or bone fracture
- Evidence of bleeding diathesis or coagulopathy
- History of other disease or metabolic dysfunction
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137774
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02115 | |
| Dana-Farber Cancer Insitute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Matthew H. Kulke, MD | Dana-Farber Cancer Institute |
Publications of Results:
| Responsible Party: | Matthew H. Kulke, MD, Principal Investigator, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00137774 |
| Other Study ID Numbers: |
04-272 |
| First Posted: | August 30, 2005 Key Record Dates |
| Last Update Posted: | April 9, 2013 |
| Last Verified: | April 2013 |
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Metastatic Neuroendocrine Tumor Advanced Neuroendocrine tumor Bevacizumab Temozolomide |
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Neuroendocrine Tumors Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Bevacizumab Temozolomide Antineoplastic Agents, Immunological |
Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |