Ovarian Endometrioid Adenocarcinoma Clinical Trial
Official title:
Feasibility Study: Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients
This early phase I trial studies giving propranolol hydrochloride with standard chemotherapy in treating patients with ovarian, primary peritoneal, or fallopian tube cancer. Biological therapies, such as propranolol hydrochloride, blocks certain chemicals that affect the heart and this may stimulate the immune system and allow the chemotherapy to kill more tumor cells.
PRIMARY OBJECTIVES:
I. To determine the feasibility of pharmacologic beta-adrenergic blockade in women with
stages II-IV epithelial ovarian cancer patients (n=25) either during initial tumor reductive
surgery and through the first six cycles of standard intravenous chemotherapy or during
neoadjuvant chemotherapy followed by surgery and further chemotherapy (chemo) up to a total
of 6 cycles.
SECONDARY OBJECTIVES:
I. To characterize the biobehavioral states of these patients by using the Functional
Assessment of Chronic Illness and Therapy- Ovary (FACT-O), Hospital Anxiety and Depression
Survey (HADS) and the Center for Epidemiologic Studies Depression Scale (CESD) and serum
levels of angiogenic cytokines at points pre- and post-treatment with beta-blockers.
II. To follow patients for progression-free survival (PFS) and overall survival (OS).
TRANSLATIONAL OBJECTIVES:
I. Determining vascular endothelial growth factor (VEGF), interleukin (IL)-6, IL-8, and other
cytokines levels in patients with ovarian cancer who are receiving beta-blockers and
comparing these levels pre-treatment and during treatment with response.
OUTLINE:
Patients receive propranolol hydrochloride orally (PO) twice daily (BID) beginning 48-72
hours before treatment. Patients undergoing surgery resume propranolol hydrochloride
post-operatively once oral drugs are tolerated and continue until completion of 6 cycles of
chemotherapy. Patients undergoing neoadjuvant chemotherapy continue propranolol hydrochloride
PO BID during 3 chemotherapy cycles pre-surgery and 3 cycles post-surgery. Treatment repeats
every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05276973 -
Testing the Addition of Ipatasertib to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) for Stage III or IV Epithelial Ovarian Cancer
|
Phase 1 | |
| Completed |
NCT01010126 -
Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT01167712 -
Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT03648489 -
Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma)
|
Phase 2 | |
| Completed |
NCT00262847 -
Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
|
Phase 3 | |
| Completed |
NCT02853318 -
Pembrolizumab, Bevacizumab, and Cyclophosphamide in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
|
Phase 2 | |
| Completed |
NCT00989651 -
Carboplatin, Paclitaxel, Bevacizumab, and Veliparib in Treating Patients With Newly Diagnosed Stage II-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT03587311 -
Bevacizumab and Anetumab Ravtansine or Paclitaxel in Treating Patients With Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
|
Phase 2 | |
| Completed |
NCT01459380 -
Pegylated Liposomal Doxorubicin Hydrochloride, Carboplatin, Veliparib, and Bevacizumab in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
|
Phase 1 | |
| Terminated |
NCT03924245 -
Olaparib and Entinostat in Patients With Recurrent, Platinum-Refractory, Resistant Ovarian, Primary Peritoneal, Fallopian Tube Cancers
|
Phase 1 | |
| Completed |
NCT00028496 -
Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer
|
Phase 1 | |
| Terminated |
NCT00004221 -
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT02713386 -
Ruxolitinib Phosphate, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT02283658 -
Everolimus and Letrozole in Treating Patients With Recurrent Hormone Receptor Positive Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer
|
Phase 2 | |
| Terminated |
NCT02923739 -
Paclitaxel and Bevacizumab With or Without Emactuzumab in Treating Patients With Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT02502266 -
Testing the Combination of Cediranib and Olaparib in Comparison to Each Drug Alone or Other Chemotherapy in Recurrent Platinum-Resistant Ovarian Cancer
|
Phase 2/Phase 3 | |
| Completed |
NCT00466960 -
Sargramostim and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Previous Chemotherapy
|
Phase 2 | |
| Completed |
NCT00085358 -
Carboplatin and Paclitaxel With or Without Bevacizumab Compared to Docetaxel, Carboplatin, and Paclitaxel in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Carcinoma (Cancer)
|
Phase 1 | |
| Active, not recruiting |
NCT02142803 -
TORC1/2 Inhibitor MLN0128 and Bevacizumab in Treating Patients With Recurrent Glioblastoma or Advanced Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT02068794 -
MV-NIS Infected Mesenchymal Stem Cells in Treating Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancer
|
Phase 1/Phase 2 |