Primary Peritoneal Cancer Clinical Trial
Official title:
TAME: A Pilot Study of Weekly Paclitaxel, Bevacizumab, and Tumor Associated Macrophage Targeted Therapy (Zoledronic Acid) in Women With Recurrent, Platinum-resistant, Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
This is a randomized pilot trial of weekly paclitaxel and bevacizumab with or without zoledronic acid in women with platinum-resistant epithelial ovarian cancer with 1-2 prior regimens for recurrence.
Primary Objective: -To assess macrophage counts by image cytometry in women with platinum resistant ovarian cancer treated with weekly paclitaxel/bevacizumab and ZA relative to weekly paclitaxel/bevacizumab. The primary endpoint is the percentage changes in macrophage count from baseline to after 2 cycles of therapy. Secondary Objective: - To estimate the progression free survival (PFS) of combination weekly paclitaxel/bevacizumab and ZA relative to weekly paclitaxel/bevacizumab in women with platinum-resistant recurrent ovarian cancer - To evaluate toxicity of the two arms - To assess objective response and duration of response by RECIST 1.1 - To estimate overall survival Exploratory Objective To assess differential effects from baseline, within and between patient treatment cohorts, on macrophage and hypoxia markers, CSF1/R and MHCII, plasma biomarker (VEGF, VEGFR, IL6, IL8, FGF, PDGFAA), tumor and macrophage-derived exosomes, and single-cell level changes. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03393884 -
Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2)
|
Phase 1/Phase 2 | |
| Completed |
NCT04546373 -
Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer
|
||
| Recruiting |
NCT05456685 -
IMGN853 With Carboplatin in Second-line Treatment of FRα Expressing, Platinum-sensitive Epithelial Ovarian Cancer
|
Phase 2 | |
| Recruiting |
NCT05494580 -
Pamiparib Plus Surufatinib in Patients With Platinum-resistant Ovarian Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT02928549 -
Factors Associated With the Use of a High Volume Cancer Center by Black Women With Ovarian Cancer: A Qualitative Study
|
||
| Completed |
NCT02480374 -
Study of Safety & Biological Activity of IP IMNN-001 (Also Known as GEN-1) With Neoadjuvant Chemo in Ovarian Cancer
|
Phase 1 | |
| Completed |
NCT01899599 -
PankoMab-GEX™ Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer
|
Phase 2 | |
| Completed |
NCT01219777 -
Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel \Bevacizumab for Primary Ovarian
|
Phase 1 | |
| Completed |
NCT00959582 -
Positron Emission Tomography/Computed Tomography (PET/CT) in Relapsed Ovarian Cancer (MK-0000-143)
|
Phase 1 | |
| Terminated |
NCT00418093 -
Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma
|
Phase 2 | |
| Completed |
NCT00314678 -
Cisplatin Induction With Paclitaxel Consolidation for Stage III-IV Epithelial Ovarian and Primary Peritoneal Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT04889495 -
A Post-marketing Surveillance to Assess the Safety and Effectiveness of Zirabev in Domestic Patients With Various Cancer
|
||
| Completed |
NCT01666444 -
VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
|
Phase 2 | |
| Recruiting |
NCT05665023 -
Bevacizumab Plus Modiifed FOLFIRINOX in Ovarian, Fallopian Tube, or Primary Peritoneal Mucinous Carcinoma
|
Phase 2 | |
| Terminated |
NCT01744821 -
Vitamin D for Women at Increased Risk of Developing Ovarian, Fallopian, or Primary Peritoneal Cancer
|
N/A | |
| Active, not recruiting |
NCT01220154 -
Study of Intraperitoneal Carboplatin With IV Paclitaxel and Bevacizumab in Untreated Ovarian Cancer
|
Phase 1 | |
| Completed |
NCT03213964 -
Intraperitoneal Delivery of Adaptive Natural Killer (NK) Cells (FATE-NK100) With Intraperitoneal Int
|
Phase 1 | |
| Not yet recruiting |
NCT06063070 -
First-line Maintenance Treatment With Fluzoparib Plus Bevacizumab in Advanced BRCA Wild Type Ovarian Cancer
|
Phase 2 | |
| Completed |
NCT01253681 -
Study of AMG 386 in Combination With Paclitaxel and Carboplatin in Subjects With Ovarian Cancer
|
Phase 1 | |
| Completed |
NCT01204749 -
TRINOVA-1: A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer
|
Phase 3 |