Cervical Adenocarcinoma Clinical Trial
Official title:
A Phase I Study of Whole Pelvic Radiation Therapy With Concomitant Cisplatin and Gemcitabine Chemotherapy in Patients With Cervical Carcinoma (Stages I-IV) Limited to the Pelvis
This phase I trial is studying the side effects and best dose of gemcitabine when given together with radiation therapy and cisplatin in treating patients with cervical cancer that has not spread beyond the pelvis. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining cisplatin with gemcitabine may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells.
PRIMARY OBJECTIVES:
I. Determine the toxicity of pelvic radiotherapy and concurrent cisplatin and gemcitabine in
patients with cervical carcinoma limited to the pelvis.
II. Determine the maximum tolerated dose (MTD) of gemcitabine in combination with cisplatin
and pelvic radiotherapy in these patients.
SECONDARY OBJECTIVES:
I. Determine the progression-free and overall survival of patients treated with gemcitabine
at the MTD in this regimen.
II. Determine the site of recurrence, local versus distant, in patients treated with this
regimen.
OUTLINE: This is a multicenter, dose-escalation study of gemcitabine.
Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour on days 1, 8,
15, 22, 29, and 36 in the absence of disease progression or unacceptable toxicity. Patients
also undergo external whole pelvis radiotherapy once daily on days 1-5, 8-13, 15-20, 22-27,
and 29-34. After completion of external beam radiotherapy, patients undergo intracavitary
radiotherapy and parametrial radiotherapy. The total elapsed time for completion of all
radiotherapy is not more than 8 weeks.
Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which 1 of 6 patients
experiences dose-limiting toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
;
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 |
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 |
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 | |
| Completed |
NCT02921269 -
Atezolizumab and Bevacizumab in Treating Patients With Recurrent, Persistent, or Metastatic Cervical Cancer
|
Phase 2 |