Recurrent Ovarian Carcinoma Clinical Trial
Official title:
A Phase II Evaluation of the Poly (ADP-Ribose) Polymerase (PARP)-1 and -2 Inhibitor Veliparib (ABT-888) (NSC#737664) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients Who Carry a Germline BRCA1 or BRCA2 Mutation
This phase II trial studies how well veliparib works in treating patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer that has come back or does not respond to treatment. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To estimate the proportion of patients who have objective tumor response (complete or
partial).
II. To determine the frequency and severity of adverse events associated with treatment with
veliparib (ABT-888) as assessed by the Active Version of the National Cancer Institute (NCI)
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
SECONDARY OBJECTIVES:
I. To determine the duration of progression-free survival (PFS) and overall survival (OS).
II. To determine the proportion of patients who survive progression-free for at least 6
months.
TERTIARY OBJECTIVES:
I. To explore the association between single nucleotide polymorphisms (SNPs) in
deoxyribonucleic acid (DNA) repair genes (e.g., breast cancer [BRCA]1, Fanconi) and clinical
characteristics, response, and patient outcome (PFS and OS).
OUTLINE:
Patients receive veliparib orally (PO) twice daily (BID) on days 1-28. Courses repeat every
28 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 |