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Evaluation of Hypoxia by EF5 Binding in Gynecologic Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Primary Peritoneal Cavity Cancer, Stage I Endometrial Carcinoma, Stage I Ovarian Epithelial Cancer, Stage IA Cervical Cancer, Stage IB Cervical Cancer, Stage II Endometrial Carcinoma, Stage II Ovarian Epithelial Cancer, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer, Stage III Cervical Cancer, Stage III Endometrial Carcinoma, Stage III Ovarian Epithelial Cancer, Stage IV Endometrial Carcinoma, Stage IV Ovarian Epithelial Cancer, Stage IVA Cervical Cancer, Stage IVB Cervical Cancer

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Trial Information

Evaluation of Hypoxia by EF5 Binding in Gynecologic Cancer


PRIMARY OBJECTIVES:

I. Correlate the level of EF5 binding with pre-treatment hemoglobin level and tumor grade
and stage in patients undergoing surgery or biopsy for cervical, endometrial, or ovarian
epithelial cancer.

SECONDARY OBJECTIVES:

I. Correlate pre-treatment tumor hypoxia (as measured by EF5 binding) with time to
progression and time to recurrence in these patients.

II. Correlate EF5 binding with CD-31 expression (tumor vasculature), Ki-67 expression
(cellular proliferation), and erythropoietin signaling in these patients.

OUTLINE:

Patients receive EF5 IV over 1-2½ hours on day 1. Approximately 1-2 days later, patients
undergo tumor resection or biopsy. Patients' tumor tissue samples undergo
immunohistochemistry and flow cytometry to detect EF5 binding levels. Patients' blood is
drawn immediately before and 30-60 minutes and 1-2 days after receiving EF5 to measure
systemic EF5 binding levels.

Patients are followed at 30-45 days after administration of EF5 and then every 3-6 months
thereafter.


Inclusion Criteria:



- Histologically confirmed* diagnosis of 1 of the following:

- Cervical cancer

- Ovarian epithelial cancer

- Endometrial cancer

- Peritoneal cavity cancer

- Requires surgery or biopsy for diagnosis or as standard initial treatment for the
tumor

- Performance status - ECOG 0-2

- WBC ≥ 2,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Bilirubin normal

- Creatinine normal

- Creatinine clearance ≥ 60 mL/min

- No significant cardiac condition that would preclude study participation

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 1 month after study
participation

- Weight ≤ 130 kg

- No other significant medical condition that would preclude study participation

- No scheduled chemotherapy for the tumor within the past 3 months

- No scheduled radiotherapy to the tumor within the past 3 months

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Level of EF5 binding

Outcome Description:

The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.

Outcome Time Frame:

Baseline

Safety Issue:

No

Principal Investigator

Christina Chu

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02649

NCT ID:

NCT00107445

Start Date:

February 2005

Completion Date:

Related Keywords:

  • Primary Peritoneal Cavity Cancer
  • Stage I Endometrial Carcinoma
  • Stage I Ovarian Epithelial Cancer
  • Stage IA Cervical Cancer
  • Stage IB Cervical Cancer
  • Stage II Endometrial Carcinoma
  • Stage II Ovarian Epithelial Cancer
  • Stage IIA Cervical Cancer
  • Stage IIB Cervical Cancer
  • Stage III Cervical Cancer
  • Stage III Endometrial Carcinoma
  • Stage III Ovarian Epithelial Cancer
  • Stage IV Endometrial Carcinoma
  • Stage IV Ovarian Epithelial Cancer
  • Stage IVA Cervical Cancer
  • Stage IVB Cervical Cancer
  • Carcinoma
  • Uterine Cervical Neoplasms
  • Peritoneal Neoplasms
  • Adenoma
  • Endometrial Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms

Name

Location
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283