Stage IV Breast Cancer Clinical Trial
Official title:
Phase I Clinical Trial of Temsirolimus and Vinorelbine in Advanced Solid Tumors.
RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Drugs used in chemotherapy, such as vinorelbine ditartrate, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Giving temsirolimus together with vinorelbine ditartrate may kill more
tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of giving
temsirolimus and vinorelbine ditartrate together in treating patients with unresectable or
metastatic solid tumors.
PRIMARY OBJECTIVES:
I. To determine the maximal tolerated dose (MTD) for the combination of temsirolimus and
vinorelbine in advanced solid tumors.
II. To obtain preliminary information regarding the activity of this combination.
SECONDARY OBJECTIVES:
I. To evaluate the safety and tolerability of this combination.
OUTLINE:
Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22 and vinorelbine
ditartrate IV over 5-10 minutes on days 1 and 15. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01987726 -
Comprehensive Gene Sequencing in Guiding Treatment Recommendations Patients With Metastatic or Recurrent Solid Tumors
|
||
| Completed |
NCT01881230 -
Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)
|
Phase 2/Phase 3 | |
| Terminated |
NCT01918306 -
GDC-0941 and Cisplatin in Treating Patients With Androgen Receptor-Negative Triple Negative Metastatic Breast Cancer
|
Phase 1/Phase 2 | |
| Terminated |
NCT01705340 -
Akt Inhibitor MK2206, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With Locally Advanced or Metastatic HER2-Positive Breast , Gastric, or Gastroesophageal Cancer That Cannot Be Removed By Surgery
|
Phase 1 | |
| Terminated |
NCT01222377 -
Endoscopic Breast Surgery in Treating Patients With Breast Cancer
|
N/A | |
| Completed |
NCT00602043 -
F-18 16 Alpha-Fluoroestradiol-Labeled Positron Emission Tomography in Predicting Response to First-Line Hormone Therapy in Patients With Stage IV Breast Cancer
|
Phase 2 | |
| Completed |
NCT00425672 -
ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment
|
Phase 1/Phase 2 | |
| Completed |
NCT00244881 -
A Phase II Study of AZD2171 in Breast Cancer Stage IV (10006202)
|
Phase 2 | |
| Completed |
NCT00096109 -
Tanespimycin in Treating Women With Refractory Locally Advanced or Metastatic Breast Cancer
|
Phase 2 | |
| Completed |
NCT00100750 -
Tipifarnib and Gemcitabine Hydrochloride in Treating Women With Metastatic Breast Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT00096434 -
Sorafenib in Treating Patients With Metastatic Breast Cancer
|
Phase 2 | |
| Completed |
NCT00057941 -
Anastrozole and ZD1839 Compared With Fulvestrant and ZD1839 in Postmenopausal Women w/ Metastatic Breast Cancer
|
Phase 2 | |
| Terminated |
NCT02892734 -
Ipilimumab and Nivolumab in Treating Patients With Recurrent Stage IV HER2 Negative Inflammatory Breast Cancer
|
Phase 2 | |
| Recruiting |
NCT03213041 -
Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer
|
Phase 2 | |
| Completed |
NCT02015559 -
Mucoadhesive Oral Wound Rinse in Preventing and Treating Stomatitis in Patients With ER- or PR-Positive Metastatic or Locally Recurrent Breast Cancer That Cannot be Removed by Surgery Receiving Everolimus
|
Phase 2 | |
| Completed |
NCT02728596 -
S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)
|
N/A | |
| Completed |
NCT03364348 -
4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer
|
Phase 1 | |
| Completed |
NCT02897375 -
Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT01672684 -
Phase I: At-Home Support for Rural Women Using Group Video Calling
|
Phase 1 | |
| Terminated |
NCT01149356 -
RO4929097 And Exemestane in Treating Pre- and Postmenopausal Patients With Advanced or Metastatic Breast Cancer
|
Phase 1 |