Primary Peritoneal Cavity CancerPhase 2NCT00107445
EF5 in Finding Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Cervical, Endometrial, or Ovarian Epithelial Cancer
A Phase 2 study testing EF5 in people with Primary Peritoneal Cavity Cancer and Stage I Endometrial Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Primary Peritoneal Cavity Cancer, Stage I Endometrial Carcinoma, Stage I Ovarian Epithelial Cancer
- What is being tested?
- EF5
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Sep 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 21Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Evaluation of Hypoxia by EF5 Binding in Gynecologic Cancer
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
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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
- Being tested
- EF5
- Medical subject headings
- Endometrial Neoplasms, Carcinoma, Ovarian Epithelial, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EF5Drug
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (EF5) | Experimental | 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. Receives: Drug: EF5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of EF5 binding
The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.
Measured: Baseline
Hemoglobin level
The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.
Measured: Baseline
Time to progression
Analyzed using Kaplan-Meier procedures.
Measured: Up to 1 year
Time to recurrence
Analyzed using Kaplan-Meier procedures.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2005 (estimated)
- Study startFeb 2005
- Primary completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Peritoneal Cavity CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Christina Chu, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00107445
- Sponsor's protocol ID
- NCI-2012-02649
- Other IDs
- UPCC-03804, R21CA099346, CDR0000419673
- Status last verified
- Jan 2013
- First submitted
- 5 Apr 2005
- Last updated
- 16 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hypoxia by EF5 Binding in Gynecologic Cancer
- ClinicalTrials.gov ID
- NCT00107445
- Acronym / sponsor ID
- NCI-2012-02649
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Feb 2005
- Primary completion
- Sep 2005 (actual)
- First posted
- 6 Apr 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (EF5) | Experimental | Drug: EF5Patients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Histologically confirmed* diagnosis of 1 of the following:
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EF5Given IV | Drug | Treatment (EF5) |
Primary outcome
Level of EF5 binding
Time frame: Baseline
The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.
Hemoglobin level
Time frame: Baseline
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
Analyzed using Kaplan-Meier procedures.
Time to recurrence
Time frame: Up to 1 year
Analyzed using Kaplan-Meier procedures.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Chu principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EF5 in people with Primary Peritoneal Cavity Cancer and Stage I Endometrial Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of EF5 binding (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.