EF5 in Finding Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Cervical, Endometrial, or Ovarian Epithelial Cancer

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Stage IVA Cervical Cancer; Stage I Endometrial Carcinoma; Stage IB Cervical Cancer; Stage II Endometrial Carcinoma; Stage IV Endometrial Carcinoma; Stage IVB Cervical Cancer; Stage IV Ovarian Epithelial Cancer; Stage I Ovarian Epithelial Cancer; Stage III Ovarian Epithelial Cancer; Stage III Cervical Cancer; Primary Peritoneal Cavity Cancer; Stage II Ovarian Epithelial Cancer; Stage IIB Cervical Cancer; Stage IIA Cervical Cancer; Stage III Endometrial Carcinoma; Stage IA Cervical Cancer

Treatments: Drug: EF5

Study type: Interventional

Funder types: NIH

Identifiers

NCT00107445

UPCC-03804

NCI-2012-02649

CDR0000419673 (Registry Identifier)

R21CA099346 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Treatment (EF5)

Experimental group

Description:

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.

Treatment:

Drug: EF5