Recurrent Ovarian Carcinoma Clinical Trial
Official title:
A Randomized Phase II Evaluation of Single-Agent Bevacizumab (NSC #704865) and Combination Bevacizumab With Fosbretabulin Tromethamine (CA4P) (NSC #752293) in the Treatment of Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
This randomized phase II trial studies how well bevacizumab with or without fosbretabulin tromethamine works in treating patients with ovarian epithelial, fallopian tube, or peritoneal cavity cancer that has come back or is persistent. Monoclonal antibodies, such as bevacizumab, find tumor cells and help kill them. Bevacizumab and fosbretabulin tromethamine may stop the growth of ovarian cancer by blocking blood flow to the tumor. It is not yet known whether bevacizumab is more effective with or without fosbretabulin tromethamine in treating ovarian epithelial, fallopian tube, and peritoneal cavity cancer.
PRIMARY OBJECTIVES:
I. To estimate the progression-free survival hazard ratio of the combination of bevacizumab
and fosbretabulin tromethamine (CA4P) compared to bevacizumab alone in patients with
persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer.
SECONDARY OBJECTIVES:
I. To determine the nature and degree of toxicity of fosbretabulin tromethamine plus
bevacizumab.
II. To characterize and compare progression-free survival in patients with measurable disease
(Response Evaluation Criteria in Solid Tumors [RECIST] criteria) and patients with detectable
(non-measurable) disease between regimens.
III. To determine the overall survival for both regimens. IV. To estimate the proportion of
patients with measurable disease who have objective tumor responses by treatment.
V. To provide descriptive information about cancer antigen (CA)-125 responses by regimen and
where possible by objective tumor responses.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive bevacizumab intravenously (IV) over 30-90 minutes on day 1. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive bevacizumab IV over 30-90 minutes and fosbretabulin tromethamine IV
over 10-20 minutes on day 1. Courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01010126 -
Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
|
Phase 2 | |
| Recruiting |
NCT05920798 -
A Study of FRaDCs for Ovarian Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03968406 -
Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers
|
Phase 1 | |
| Active, not recruiting |
NCT03508570 -
Nivolumab With or Without Ipilimumab in Treating Patients With Recurrent or High Grade Gynecologic Cancer With Metastatic Peritoneal Carcinomatosis
|
Phase 1 | |
| Completed |
NCT00301756 -
Belinostat in Treating Patients With Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer or Ovarian Low Malignant Potential Tumors
|
Phase 2 | |
| Completed |
NCT00066456 -
Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer
|
Phase 1 | |
| Completed |
NCT00045682 -
CT-2103 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03353831 -
Atezolizumab With Bevacizumab and Chemotherapy vs Bevacizumab and Chemotherapy in Early Relapse Ovarian Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT04781088 -
Lenvatinib, Pembrolizumab, and Paclitaxel for Treatment of Recurrent Endometrial, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
|
Phase 2 | |
| Completed |
NCT02853318 -
Pembrolizumab, Bevacizumab, and Cyclophosphamide in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03325634 -
Stereotactic Body Radiation Therapy in Treating Patients With Recurrent Primary Ovarian or Uterine Cancer
|
Phase 1 | |
| Completed |
NCT01039207 -
Rilotumumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
|
Phase 2 | |
| Withdrawn |
NCT00551265 -
Oregovomab With or Without Cyclophosphamide in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Responded to Second-Line Chemotherapy
|
N/A | |
| Completed |
NCT00093626 -
Sorafenib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer
|
Phase 2 | |
| Terminated |
NCT02569957 -
Effect of Acetylcysteine With Topotecan Hydrochloride on the Tumor Microenvironment in Patients With Persistent or Recurrent High Grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
|
Phase 2 | |
| Recruiting |
NCT04469764 -
Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT01081262 -
Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT04019288 -
AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
|
Phase 1/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 |