Cervical Adenocarcinoma Clinical Trial
Official title:
A Phase I Trial of Tailored Radiation Therapy With Concomitant Cetuximab (C225, NSC #714692) and Cisplatin (NSC #119875) in the Treatment of Patients With Cervical Cancer
This phase I trial is studying the side effects and best dose of cetuximab when given together with cisplatin and radiation therapy in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer. Monoclonal antibodies, such as cetuximab, 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. 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. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving cetuximab together with cisplatin and radiation therapy may kill more tumor cells.
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose or safe biologically effective dose of cetuximab
when administered in combination with cisplatin, external beam radiotherapy, and
brachytherapy in patients with stage IB-IVA cervical cancer.
II. Determine the feasibility of this regimen, in terms of chronic and acute toxic effects,
in these patients.
SECONDARY OBJECTIVES:
I. Determine the distribution of progression-free survival and overall survival of patients
treated with this regimen at 1 year after study entry.
II. Determine the site of recurrence (locoregional vs distant) in patients treated with this
regimen up to 1 year after study entry.
III. Correlate response or progression-free survival with epidermal growth factor receptor
expression in tumor samples from patients treated with this regimen at 1 year after study
entry.
IV. Correlate response or progression-free survival with grade of cetuximab-induced rash in
patients treated with this regimen at 1 year after study entry.
OUTLINE: This is a multicenter, dose-escalation study of cetuximab. Patients are stratified
according to nodal status (positive para-aortic and/or pelvic lymph nodes vs negative
para-aortic and pelvic lymph nodes).
Patients receive cetuximab IV over 1-2 hours and cisplatin IV on days 1, 8, 15, 22, 29, and
36 (weeks 1-6). Patients also undergo external beam radiotherapy to the para-aortic and
pelvic lymph nodes OR whole pelvis once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33
(weeks 1-5). Patients then receive either 1 or 2 applications of low-dose rate brachytherapy
in weeks 6-8 OR 5 applications of high-dose rate (HDR)* brachytherapy once weekly in weeks
4-8. Treatment continues in the absence of disease progression or unacceptable toxicity.
NOTE: *No external beam radiotherapy is administered on the day of HDR brachytherapy. If the
majority of external beam radiotherapy has been administered, HDR brachytherapy may be
administered in 2 applications per week (separated by at least 72 hours) in order to
complete all treatment within 8 weeks.
Cohorts of 3-6 patients per stratum receive escalating doses of cetuximab until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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 |