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Status:

WITHDRAWN

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

Lead Sponsor:

University of Alabama at Birmingham

Collaborating Sponsors:

MedImmune LLC

Conditions:

Cervical Cancer

Eligibility:

FEMALE

19+ years

Phase:

PHASE1

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 lymp...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00137358

Last Update

January 24 2013

Active Locations (1)

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1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294