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

Primary Purpose

Cervical Cancer

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Radiation Therapy

Cisplatin

Amifostine

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring Cervical, Uterine, Para-aortic, Nodes, IMRT, Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

University of Alabama at Birmingham

Outcomes

Primary Outcome Measures

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

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

Full Information

NCT ID

NCT00137358

First Posted

August 26, 2005

Last Updated

January 23, 2013

Sponsor

University of Alabama at Birmingham

Collaborators

MedImmune LLC

1. Study Identification

Unique Protocol Identification Number

NCT00137358

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Withdrawn

Why Stopped

unable to obtain funding to conduct study

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

Collaborators

MedImmune LLC

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

Keywords

Cervical, Uterine, Para-aortic, Nodes, IMRT, Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Radiation Therapy

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Type

Drug

Intervention Name(s)

Amifostine

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer F De Los Santos, MD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

11704321

Citation

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

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