Radiation With Chemotherapy and a Study Drug to the Para-Aortic Nodes in Cervical Cancer

January 23, 2013 updated by: Jennifer F. De Los Santos, University of Alabama at Birmingham

Phase I Trial of Dose Escalated IMRT to the Para-aortic Nodes With Concurrent Cisplatin and Amifostine in Locally Advanced Cervical Cancer

Investigator has since decided not to pursue this protocol further. No patients were enrolled.

This study is to determine the maximum tolerated dose of external beam radiation to the para-aortic lymph nodes using intensity modulated radiation therapy (IMRT).

This protocol will test the hypothesis that the use of IMRT and amifostine will decrease GI toxicity and therefore allow the radiation dose to the para-aortic lymph nodes to be safely escalated.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This is a Phase I open-label multi-institutional study that will enroll a minimum of 27 and up to 42 patients with locally advanced cervical cancer (a minimum of 27 will be entered if all dose levels are explored without reaching a dose limiting toxicity at any level). The primary objective is to determine the maximum tolerated dose (MTD) of external beam radiation to the para-aortic lymph nodes using IMRT and amifostine. Patients will be stratified according to gross tumor volume (GTV) prior to dose escalation.

Within each GTV stratum, the dose escalation will be determined as follows: Accrue 3 patients in the first dose level based on the determined stratum. A Dose Limiting Toxicity is defined as the development of > Grade 3 acute GI toxicity, per the RTOG acute toxicity scale. If no DLT is observed at the first dose level, 3 patients will be enrolled at the next dose level. If one patient experiences DLT at a given dose level, 3 additional patients will be enrolled at that dose level. If 0 of these 3 additional patients experience DLT, dosing of the next dose level is begun. If 1 or more of these 3 additional patients experience DLT at the highest dose level below the maximally administered dose, this dose becomes the recommended dose. At least 6 patients must be entered at this recommended dose. The Maximum Tolerated Dose (MTD) is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • No prior therapy other than biopsy of the cervix or endoscopic pelvic nodal resection.
  • Patients may have endoscopic resection of enlarged pelvic and low common iliac nodes, however, needle biopsy only of enlarged para-aortic nodes will be eligible for entry.
  • Patients with squamous cell, adenocarcinoma, and adenosquamous carcinoma are eligible.
  • Patients must have no evidence of metastatic disease outside of the pelvis (except to the para-aortic nodes).
  • Patients must have Zubrod performance status 0-1 and no medical contraindications to the administration of full dose chemotherapy.
  • Patients must have a life expectancy > 6 months
  • Adequate bone marrow function: white blood cell (WBC) 3000/mm3 (absolute neutrophil count [ANC] 1500/mm3); adequate renal function: creatinine 1.5 mg/dl (urinary diversion is permitted to improve renal function); patients must have bilirubin 1.5 mg/dl, ALT 2 x normal.
  • No prior (within last 3 years) or simultaneous malignancies (other than basal cell or non-invasive tumors)

Exclusion Criteria:

  • Complete resection of the involved para-aortic nodes.
  • Patients with evidence of bowel adherent to the GTV by contrast enhanced computed tomography (CT) scan will be ineligible.
  • Patients with the following histologies will be ineligible: glassy cell, small cell, carcinoid, adenoid cystic, and clear cell.
  • Prior (within last 3 years) malignancies other than basal cell carcinoma or non-invasive malignancies.
  • Prior chemotherapy.
  • Prior pelvic or abdominal radiation (other than transvaginal irradiation to control bleeding).
  • Prior tumor-directed surgery other than lymph node sampling/staging
  • Life expectancy < 6 months
  • Patients who are pregnant will be ineligible.
  • Patients with insulin dependent diabetes will be ineligible.
  • Patients who are obese, such that reliable immobilization is not achieved.
  • Patients with pain or discomfort that would preclude lying still for extended periods of time.
  • Patients with tumors that are bleeding and require more immediate treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary objective is to determine the maximum tolerated dose (MTD) of external beam radiation to the para-aortic lymph nodes using IMRT and amifostine.

Secondary Outcome Measures

Outcome Measure
The secondary endpoints include local-regional control, overall survival and toxicity.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

MedImmune LLC

Investigators

  • Principal Investigator: Jennifer F De Los Santos, MD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 26, 2005

First Submitted That Met QC Criteria

August 26, 2005

First Posted (Estimate)

August 29, 2005

Study Record Updates

Last Update Posted (Estimate)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETH175-04D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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