Cervical Adenocarcinoma Clinical Trial
Official title:
A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA
This phase II trial is studying how well giving bevacizumab together with radiation therapy and cisplatin works in treating patients with previously untreated locally advanced cervical cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of cervical cancer by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with radiation therapy and cisplatin may kill more tumor cells.
PRIMARY OBJECTIVES:
I. Determine treatment-related serious adverse-event rates and adverse-event rates within the
first 90 days from treatment start in patients with previously untreated locally advanced
carcinoma of the cervix treated with bevacizumab, cisplatin, and concurrent pelvic
radiotherapy.
SECONDARY OBJECTIVES:
I. Evaluate treatment-related serious adverse events and adverse events at any time.
II. Evaluate disease-free survival (local, regional, or distant failure, or death due to any
cause).
III. Evaluate overall survival (death due to any cause). IV. Implement the image-based
brachytherapy guidelines proposed by the Transatlantic Image-Guided Brachytherapy Working
Group.
V. Collect CT scan or MRI-based dosimetry of brachytherapy applications used during the
course of treatment for later analysis of feasibility and consistency as well as dose/volume
assessments of tumor control and complications.
OUTLINE: This is a multicenter study.
Patients undergo pelvic external-beam radiotherapy (EBRT) once daily, 5 days a week, for 5
weeks for a total of 45 Gy.
Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4
weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart,
beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of
high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1,
15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.
After completion of study treatment, patients are followed periodically.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02562729 -
Complete Nerve-Sparing Radical Hysterectomy for Cervical Cancer
|
Phase 2 | |
| Completed |
NCT00054444 -
Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer
|
Phase 1 | |
| 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 | |
| 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 |