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| Sponsor: | Northwestern University |
|---|---|
| Collaborators: |
Robert H. Lurie Cancer Center National Comprehensive Cancer Network GlaxoSmithKline |
| Information provided by (Responsible Party): | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT01465659 |
Purpose
This phase I/II trial studies the side effects and best dose of temozolomide and pazopanib hydrochloride when given together and to see how well they work in treating patients with advanced pancreatic neuroendocrine tumors (PNET) that cannot be removed by surgery. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for tumor growth. Giving temozolomide together with pazopanib hydrochloride may be an effective treatment for patients with PNET.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Alpha Cell Carcinoma Pancreatic Beta Islet Cell Carcinoma Pancreatic Delta Cell Carcinoma Pancreatic G-cell Carcinoma Recurrent Islet Cell Carcinoma |
Drug: temozolomide Drug: pazopanib hydrochloride |
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: | A Phase I/II Study of the Combination of Temozolomide and Pazopanib in Advanced Pancreatic Neuroendocrine Tumors (PNET) |
| Estimated Enrollment: | 39 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | August 2017 |
| Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (chemotherapy and enzyme inhibitor)
Patients receive temozolomide PO QD on days 1-7 and 15-21 and pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Drug: temozolomide
Given PO
Other Names:
Drug: pazopanib hydrochloride
Given PO
Other Names:
|
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose (MTD) of temozolomide and pazopanib (pazopanib hydrochloride) combination in patients with advanced PNET. (Phase I) II. Determine the overall response rate (ORR). (Phase II)
SECONDARY OBJECTIVES:
I. Determine safety and toxicity profile of the combination of temozolomide and pazopanib in this population. (Phase I) II. Describe the pharmacokinetics of temozolomide alone and in combination with pazopanib. (Phase I) III. Observe the ORR. (Phase I) IV. Determine progression-free survival (PFS) and overall survival (OS), disease control rate (DCR), and duration of response (DOR). (Phase II) V. Determine the safety and toxicity profile of the combination in a larger cohort of patients. (Phase II)
TERTIARY OBJECTIVES:
I. Examine the relationship between tumor blood flow, as measured by perfusion functional computed tomography (f CT), and overall response.
II. Correlate the expression of tissue methyl-guanine methyl transferase (MGMT) as measured by immunohistochemistry (IHC) with ORR and PFS.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients receive temozolomide orally (PO) once daily (QD) on days 1-7 and 15-21 and pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Study Coordinator | 312-695-1301 | cancertrials@northwestern.edu |
| United States, Illinois | |
| Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Halla null. Nimeiri 312-695-4381 h-nimeiri@northwestern.edu | |
| Principal Investigator: Halla null. Nimeiri | |
| United States, Michigan | |
| University of Michigan | Not yet recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Mark M. Zalupski 734-615-3969 zalupski@med.umich.edu | |
| Principal Investigator: Mark M. Zalupski | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| Contact: Steven J. Cohen 215-728-2570 Steven.Cohen@fccc.edu | |
| Principal Investigator: Steven J. Cohen | |
| United States, Tennessee | |
| Vanderbilt University | Not yet recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Jordan D. Berlin 615-936-8422 jordan.berlin@Vanderbilt.edu | |
| Principal Investigator: Jordan D. Berlin | |
| Principal Investigator: | Halla Nimeiri | Northwestern University |
More Information
| Responsible Party: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT01465659 History of Changes |
| Other Study ID Numbers: | NU 11I03, NCI-2011-02939 |
| Study First Received: | October 4, 2011 |
| Last Updated: | November 22, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Carcinoma Neuroendocrine Tumors Adenoma, Islet Cell Carcinoma, Islet Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Adenoma Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Adenocarcinoma Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |