Clinical trial NCT00107445: EF5 in Finding Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Cervical, Endometrial, or Ovarian Epithelial Cancer
Official title: Evaluation of Hypoxia by EF5 Binding in Gynecologic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2005-04-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This phase II trial is studying how well EF5 works in finding oxygen in tumor cells of patients who are undergoing surgery or biopsy for cervical, endometrial, or ovarian epithelial cancer. Diagnostic procedures using the drug EF5 to find oxygen in tumor cells may help in planning cancer treatment

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of EF5 binding
timeFrame: Baseline
measure: Hemoglobin level
timeFrame: Baseline
measure: Time to progression
timeFrame: Up to 1 year
measure: Time to recurrence
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of The University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Christina Chu
role: PRINCIPAL_INVESTIGATOR
References: