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

NCT ID: NCT00137358

Last Updated: 2013-01-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL

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.

Conditions

Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Radiation Therapy

Intervention Type: PROCEDURE

Cisplatin

Intervention Type: DRUG

Amifostine

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

MedImmune LLC

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Jennifer F. De Los Santos

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer F De Los Santos, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

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Other Identifiers

ETH175-04D

Identifier Type: -

Identifier Source: org_study_id