EF5 in Finding Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Cervical, Endometrial, or Ovarian Epithelial Cancer
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Drug: EF5 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Evaluation of Hypoxia by EF5 Binding in Gynecologic Cancer |
- Level of EF5 binding [ Time Frame: Baseline ] [ Designated as safety issue: No ]The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.
- Hemoglobin level [ Time Frame: Baseline ] [ Designated as safety issue: No ]The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.
- Time to progression [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]Analyzed using Kaplan-Meier procedures.
- Time to recurrence [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]Analyzed using Kaplan-Meier procedures.
| Enrollment: | 60 |
| Study Start Date: | February 2005 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (EF5)
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.
|
Drug: EF5
Given IV
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Pennsylvania | |
| Abramson Cancer Center of The University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Christina Chu | Abramson Cancer Center of the University of Pennsylvania |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00107445 History of Changes |
| Other Study ID Numbers: | NCI-2012-02649, UPCC-03804, R21CA099346, CDR0000419673 |
| Study First Received: | April 5, 2005 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma Uterine Cervical Neoplasms Peritoneal Neoplasms Adenoma Endometrial Neoplasms Neoplasms, Glandular and Epithelial Ovarian Neoplasms Neoplasms by Histologic Type Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Endocrine System Diseases Gonadal Disorders |
ClinicalTrials.gov processed this record on May 19, 2013