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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01229943 |
Purpose
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Octreotide may interfere with and slow the growth of tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab and everolimus also may stop the growth of pancreatic neuroendocrine tumors by blocking blood flow to the tumor. It is not yet known whether giving everolimus and octreotide together is more effective with or without bevacizumab in treating pancreatic neuroendocrine tumors.
PURPOSE: This randomized phase II trial is studying how well giving everolimus and octreotide together with or without bevacizumab works in treating patients with locally advanced or metastatic pancreatic neuroendocrine tumors that cannot be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Islet Cell Tumor Pancreatic Cancer |
Biological: bevacizumab Drug: everolimus Drug: octreotide acetate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Phase II Study of Everolimus Alone Versus Everolimus Plus Bevacizumab in Patients With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors |
| Estimated Enrollment: | 138 |
| Study Start Date: | October 2010 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive oral everolimus once daily on days 1-28 and intramuscular octreotide LAR on day 1.
|
Drug: everolimus
Given orally
Drug: octreotide acetate
Given intramuscularly
|
|
Experimental: Arm II
Patients receive everolimus and octreotide LAR as in arm I. Patients also receive bevacizumab IV on days 1 and 15.
|
Biological: bevacizumab
Given IV
Drug: everolimus
Given orally
Drug: octreotide acetate
Given intramuscularly
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to prior treatment with cytotoxic chemotherapy (no vs yes), prior use of octreotide (no vs yes), and prior therapy with sunitinib (no vs yes). Patients are randomized to 1 of 2 treatment arms.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3-6 months for 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Patients must have histologic documentation of well-differentiated or moderately differentiated neuroendocrine tumor from either a primary or metastatic site
Patients must have either histologic documentation of a pancreatic primary site, or clinical evidence of a pancreatic neuroendocrine primary tumor as determined by the treating physician
Patients must have evidence of disease (measurable or non-measurable) with evidence of progression within the past 12 months
Non-measurable disease is defined as all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly nonmeasurable lesions
Lesions that are considered non-measurable include the following:
Treatment with somatostatin analogs is a requirement of the study
PATIENT CHARACTERISTICS:
No active or severe liver disease (e.g., acute or chronic hepatitis, cirrhosis)
No positive anti-hepatitis B virus (HBV)
PRIOR CONCURRENT THERAPY:
Other prior treatments, including but not limited to prior cytotoxic chemotherapy, alpha interferon, tyrosine kinase inhibitors, external beam radiation therapy, and radiopeptide therapy are allowed
Prior treatment with embolization or ablative therapies is allowed if measurable disease remains outside of the treated area
Patients should have completed any major surgery ≥ 4 weeks from start of treatment
Contacts and Locations
Show 310 Study Locations| Principal Investigator: | Matthew Kulke, MD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Monica M. Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT01229943 History of Changes |
| Other Study ID Numbers: | CDR0000687459, CALGB-80701 |
| Study First Received: | October 27, 2010 |
| Last Updated: | May 23, 2012 |
| Health Authority: | Unspecified |
|
stage III pancreatic cancer stage IV pancreatic cancer recurrent pancreatic cancer pancreatic G-cell adenoma pancreatic G-cell carcinoma pancreatic alpha cell adenoma pancreatic alpha cell carcinoma pancreatic beta islet cell adenoma pancreatic beta islet cell carcinoma |
recurrent islet cell carcinoma pancreatic polypeptide tumor pancreatic delta cell adenoma pancreatic delta cell carcinoma gastrinoma glucagonoma insulinoma somatostatinoma |
|
Pancreatic Neoplasms Neuroendocrine Tumors Adenoma, Islet Cell Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Adenoma |
Neoplasms, Glandular and Epithelial Octreotide Bevacizumab Sirolimus Everolimus Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antibiotics, Antineoplastic Antifungal Agents |