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Evaluation of Hypoxia by EF5 (NSC#684681) Binding in Cervix Cancer


N/A
18 Years
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

Trial Information

Evaluation of Hypoxia by EF5 (NSC#684681) Binding in Cervix Cancer


OBJECTIVES:

- Determine the relationship between the level of EF5 binding and pretreatment hemoglobin
level, tumor size, and stage of disease in patients with stage IIB, IIIB, or IVA
cervical cancer.

- Determine whether pretreatment tumor hypoxia (measured by EF5 binding) is associated
with overall survival, progression-free interval, and local control in these patients.

- Determine the relationship between EF5 binding and CD-31 labeling (tumor vasculature)
and Ki-67 labeling (cellular proliferation) in these patients.

OUTLINE: This is a multicenter study.

Patients receive EF5 IV over 1-2.5 hours on day 1. Tumor hypoxia is measured using
immunohistochemical techniques. Biopsies are collected 1-2 days later. Blood is collected
before EF5 is administered and again at the time of surgery.

Patients are followed approximately 1 month after surgery.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or
adenosquamous carcinoma of the cervix

- Stage IIB, IIIB, or IVA

- Primary disease

- No prior treatment

- Must be enrolled on GOG-0191 protocol

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- GOG 0-3

Life expectancy

- Not specified

Hematopoietic

- See Disease Characteristics

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin no greater than 1.5 times normal

- SGOT no greater than 3 times normal

- Alkaline phosphatase no greater than 3 times normal

- Hemoglobin less than 13 g/dL

Renal

- Creatinine no greater than 2 mg/dL

Cardiovascular

- No cardiac disease that would preclude safe administration of necessary fluid volumes

Pulmonary

- No chronic pulmonary disease that would preclude safe administration of necessary
fluid volumes

Other

- No history of grade 3 or 4 peripheral neuropathy

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Must weigh no more than 180 kg

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Principal Investigator

Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon)

Investigator Role:

Study Chair

Investigator Affiliation:

Odette Cancer Centre at Sunnybrook

Authority:

United States: Federal Government

Study ID:

CDR0000258053

NCT ID:

NCT00049231

Start Date:

June 2003

Completion Date:

August 2005

Related Keywords:

  • Cervical Cancer
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • cervical squamous cell carcinoma
  • stage IIB cervical cancer
  • stage III cervical cancer
  • stage IVA cervical cancer
  • Uterine Cervical Neoplasms
  • Anoxia

Name

Location

Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Cancer Care Associates - Midtown TulsaTulsa, Oklahoma  74104
Colorado Gynecologic Oncology Group P.C.Aurora, Colorado  80010