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| Sponsor: | Mayo Clinic |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01010126 |
Purpose
RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving temsirolimus together with bevacizumab and to see how well it works in treating patients with locally advanced, recurrent, metastatic, or progressive endometrial cancer, ovarian epithelial cancer, liver cancer, islet cell cancer, or carcinoid tumor.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer Gastrointestinal Carcinoid Tumor Islet Cell Tumor Liver Cancer Lung Cancer Ovarian Cancer |
Biological: bevacizumab Drug: temsirolimus Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Temsirolimus and Bevacizumab in Patients With Endometrial, Ovarian, Hepatocellular Carcinoma, Carcinoid and Islet Cell Cancer |
| Estimated Enrollment: | 275 |
| Study Start Date: | September 2009 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to type of cancer (endometrial vs ovarian vs hepatocellular vs carcinoid vs islet cell).
Patients receive temsirolimus IV on days 1, 8, 15, and 22 and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and tumor tissue samples are collected periodically for future biomarker and other laboratory correlative studies.
After completion of study treatment, patients are followed up periodically for up to 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed diagnosis of 1 of the following:
Endometrial cancer (endometrioid only), meeting the following criteria:
Hepatocellular carcinoma (HCC), meeting the following criteria:
Biopsy-confirmed disease OR diagnosed by clinical and radiologic criteria as indicated by all of the following:
Carcinoid tumor or islet cell (well-or moderately-differentiated neuroendocrine) cancer
Ovarian epithelial cancer, meeting the following criteria:
Measurable disease
No untreated CNS metastases
Brain metastases that have been adequately treated are allowed provided there is no evidence of progression or hemorrhage after treatment as ascertained by clinical examination and brain imaging (MRI or CT scan) within the past 12 weeks AND there is no ongoing requirement for steroids
PATIENT CHARACTERISTICS:
No evidence of a history of bleeding within the past 6 months, including any of the following:
No significant cardiovascular disease, defined as any of the following:
No currently active second malignancy other than nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
At least 4 weeks since prior regional therapy for liver metastasis in patients with HCC (12 weeks for patients with islet cell cancer or carcinoid tumor)*, including any of the following:
Prior radiolabeled octreotide for islet cell cancer or carcinoid tumor allowed
No concurrent angiotensin-converting enzyme (ACE) inhibitors (e.g., benazapril, captopril, enalopril, fosonopril, lisinopril, moexipril, perindopril, quinopril, ramipril, or trandolapril)
Contacts and Locations| United States, Arizona | |
| Mayo Clinic Scottsdale | Recruiting |
| Scottsdale, Arizona, United States, 85259-5499 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, California | |
| City of Hope Comprehensive Cancer Center | Recruiting |
| Duarte, California, United States, 91010-3000 | |
| Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org | |
| United States, Florida | |
| Mayo Clinic - Jacksonville | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, New York | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | Recruiting |
| Bronx, New York, United States, 10461 | |
| Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe 718-904-2730 aecc@aecom.yu.edu | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Recruiting |
| Columbus, Ohio, United States, 43210-1240 | |
| Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 osu@emergingmed.com | |
| Canada, Ontario | |
| Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: Jennifer Knox, MD 416-946-2399 | |
| Principal Investigator: | Charles Erlichman, MD | Mayo Clinic |
More Information
| Responsible Party: | Charles Erlichman, Mayo Clinic Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01010126 History of Changes |
| Other Study ID Numbers: | CDR0000653790, MAYO-MC0845 |
| Study First Received: | November 6, 2009 |
| Last Updated: | May 2, 2012 |
| Health Authority: | Unspecified |
|
endometrial adenocarcinoma endometrial papillary serous carcinoma ovarian serous cystadenocarcinoma ovarian endometrioid adenocarcinoma ovarian mixed epithelial carcinoma ovarian undifferentiated adenocarcinoma adult primary hepatocellular carcinoma advanced adult primary liver cancer localized unresectable adult primary liver cancer recurrent adult primary liver cancer regional gastrointestinal carcinoid tumor metastatic gastrointestinal carcinoid tumor recurrent gastrointestinal carcinoid tumor pulmonary carcinoid tumor |
islet cell carcinoma recurrent islet cell carcinoma stage IIIA ovarian epithelial cancer stage IIIB ovarian epithelial cancer stage IIIC ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer stage IIIA endometrial carcinoma stage IIIB endometrial carcinoma stage IIIC endometrial carcinoma stage IVA endometrial carcinoma stage IVB endometrial carcinoma recurrent endometrial carcinoma |
|
Carcinoid Tumor Endometrial Neoplasms Sarcoma, Endometrial Stromal Liver Neoplasms Lung Neoplasms Ovarian Neoplasms Malignant Carcinoid Syndrome Gastrointestinal Neoplasms Adenoma, Islet Cell Neoplasms, Glandular and Epithelial Carcinoma, Islet Cell Carcinoma, Hepatocellular Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Adenocarcinoma Carcinoma Neoplasms, Nerve Tissue Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Sarcoma Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors |