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

This study has been withdrawn prior to enrollment.
(unable to obtain funding to conduct study)
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
Jennifer F. De Los Santos, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00137358
First received: August 26, 2005
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Procedure: Radiation Therapy
Drug: Cisplatin
Drug: Amifostine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of Dose Escalated IMRT to the Para-aortic Nodes With Concurrent Cisplatin and Amifostine in Locally Advanced Cervical Cancer

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

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.

Enrollment: 0
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137358

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
MedImmune LLC
Investigators
Principal Investigator: Jennifer F De Los Santos, MD University of Alabama at Birmingham
  More Information

Publications:
Nori D, Valentine E, Hilaris BS. The role of paraaortic node irradiation in the treatment of cancer of the cervix. Int J Radiat Oncol Biol Phys 1985; 11:1469-73.

Responsible Party: Jennifer F. De Los Santos, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00137358     History of Changes
Other Study ID Numbers: ETH175-04D
Study First Received: August 26, 2005
Last Updated: January 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Cervical
Uterine
Para-aortic
Nodes
IMRT
Cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Cisplatin
Amifostine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Protective Agents

ClinicalTrials.gov processed this record on July 23, 2014