Cervical Adenocarcinoma Clinical Trial
Official title:
A Phase II Evaluation of Brivanib (BMS582664) in the Treatment of Persistent or Recurrent Carcinoma of the Cervix (BMS Study CA182-048)
This phase II trial studies how well brivanib alaninate works in treating patients with cervical cancer that has come back. Brivanib alaninate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.
PRIMARY OBJECTIVES:
I. To estimate the proportion of patients with persistent or recurrent cervical cancer, who
survive progression-free for at least 6 months and the proportion of patients who have
objective tumor response (complete or partial), treated with brivanib (brivanib alaninate).
II. To determine the nature and degree of toxicity of brivanib in this cohort of patients.
SECONDARY OBJECTIVES:
I. To estimate the progression-free survival (PFS) and overall survival (OS) of patients with
persistent or recurrent cervical cancer treated with brivanib.
TERTIARY OBJECTIVES:
I. To obtain the serum expression levels of surrogate markers of brivanib effects including
angiogenic factors (vascular endothelial growth factor [VEGF] and basic fibroblast growth
factor [bFGF]) and markers of endothelial damage (E-selectin, vascular cell adhesion molecule
1 [VCAM-1], and (intercellular adhesion molecule 1 [ICAM-1]). (exploratory) II. To determine
whether these marker expression levels alone or in combination are associated with response,
PFS, or overall survival. (exploratory)
OUTLINE:
Patients receive brivanib alaninate orally (PO) once daily (QD) on days 1-28. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02562729 -
Complete Nerve-Sparing Radical Hysterectomy for Cervical Cancer
|
Phase 2 | |
Completed |
NCT00416455 -
Fludeoxyglucose (FDG) F 18 PET Scan, CT Scan, and Ferumoxtran-10 MRI Scan Before Chemotherapy and Radiation Therapy in Finding Lymph Node Metastasis in Patients With Locally Advanced Cervical Cancer or High-Risk Endometrial Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT00054444 -
Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer
|
Phase 1 | |
Recruiting |
NCT05210348 -
Clinical Evaluation of Detection of High Risk HPV in Urine
|
||
Active, not recruiting |
NCT02140021 -
Biospecimen Collection and Testing for the Prevalence of Anal Dysplasia and Anal Cancer in Patients With Cervical, Vaginal and Vulvar Dysplasia and Cancer
|
N/A | |
Completed |
NCT00068549 -
Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer
|
Phase 1 | |
Completed |
NCT01711515 -
Chemoradiation Therapy and Ipilimumab in Treating Patients With Stages IB2-IIB or IIIB-IVA Cervical Cancer
|
Phase 1 | |
Terminated |
NCT00924066 -
Ixabepilone to Treat Cervical Cancer
|
Phase 2 | |
Completed |
NCT00559377 -
FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer
|
Phase 2 | |
Completed |
NCT00309959 -
ABI-007 in Treating Patients With Persistent or Recurrent Cervical Cancer
|
Phase 2 | |
Active, not recruiting |
NCT05613283 -
Primary Cervical Cancer Screening by Self-sampling HPV Test
|
||
Recruiting |
NCT03742869 -
HPV Integration and Tumorigenesis of Uterine Cervical Adenocarcinoma
|
||
Withdrawn |
NCT03834571 -
Testing the Addition of Paclitaxel and Carboplatin Given After Standard Chemotherapy and Radiation for Cervical Cancer in HIV-positive Women
|
Phase 2 | |
Completed |
NCT01266460 -
Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer
|
Phase 2 | |
Completed |
NCT00064077 -
Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix
|
Phase 3 | |
Active, not recruiting |
NCT02257528 -
Nivolumab in Treating Patients With Persistent, Recurrent, or Metastatic Cervical Cancer
|
Phase 2 | |
Active, not recruiting |
NCT02466971 -
Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers
|
Phase 3 | |
Completed |
NCT02164461 -
Axalimogene Filolisbac (ADXS11-001) High Dose in Women With Human Papillomavirus (HPV) + Cervical Cancer
|
Phase 1 | |
Completed |
NCT01281852 -
Paclitaxel, Cisplatin, and Veliparib in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
|
Phase 1 | |
Active, not recruiting |
NCT04622670 -
Yoga Therapy During Chemotherapy and Radiation Treatment for the Improvement of Physical and Emotional Well-Being in Patients With Stage IB2-IIIB Cervical Cancer
|
N/A |