Ovarian NeoplasmsPhase 1NCT00473954
Safety and Efficacy of EGEN-001 Combined With Carboplatin and Docetaxel in Recurrent, Platinum-Sensitive, Ovarian Cancer
A Phase 1 study testing EGEN-001 (phIL-12-005/PPC) in people with Ovarian Neoplasms, run by EGEN, Inc. at 4 sites in United States.
Trial summary
Ovarian cancer may be caused by a build-up of genetic defects, or damaged genes within the body's cells. When genes are damaged, the body may be unable to produce a group of proteins, called cytokines, used by the immune system to fight cancer and some infections. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- EGEN-001 (phIL-12-005/PPC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2007to Nov 2009
- Phase
- Phase 1
- 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
- Be female and at least 18 years of age (or minimum legal age and competency to provide voluntary written informed consent for study participation);
- Histologically/cytologically confirmed epithelial ovarian cancer that meets one of the following criteria:
- measurable disease by computed tomography (CT) scan or
- malignant ascites, or
- Serum CA-125 levels; or
- Clinically evaluable recurrent disease by other criteria.
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- Relapsed, platinum-sensitive, ovarian cancer after induction chemotherapy (at least 6 months since last exposure to platinum based therapy).
- Eastern Cooperative Oncology Group (ECOG) Performance score of 0, 1 or 2;
- Recovered from prior chemotherapy, having adequate bone marrow function:
- Adequate renal function;
- Adequate liver function;
- If of childbearing potential, have a negative pregnancy test and agree to follow an acceptable method of birth control;
- Agree to be compliant with the study's requirements;
- Understand and sign a written Informed Consent prior to the performance of any study-related procedures.
Who cannot join
- Ovarian cancer other than documented epithelial cancer;
- Intra-abdominal disease > 5 cm in diameter;
- Any serious, uncontrolled, intercurrent medical illness or disorder including, but not limited to:
- Autoimmune disorders
- Cardiac Disorders
- Diabetes
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- Intrahepatic disease/cancer as documented by CT-scan
- An active infection within 4 weeks of study entry;
- Any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration
- Prior treatment with whole abdominal irradiation;
- Currently receiving or have received any investigational agents within 28 days of study entry;
- Received prior chemotherapy for ovarian cancer administered by the IP route;
- Received any chemotherapy between completion of primary chemotherapy for ovarian cancer and study entry (e.g. consolidation therapy);
- Receipt of immunotherapy and/or any medications with the potential to affect the activity of EGEN 001;
- Known history of HIV infection, hepatitis B, or hepatitis C;
- Known hypersensitivity to any of the components of carboplatin or docetaxel;
- Life expectancy of less than 3 months;
- Known, current, recreational drug or alcohol abuse;
- Breast feeding an infant;
- Psychiatric illness/social situations which would limit compliance with study requirements;
- Any other known condition which in the Investigator's opinion would make the patient a poor candidate for the study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Baylor College of Medicine
Houston, Texas, 77030
Oncology Specialties, PC
Huntsville, Alabama, 35805
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase 1, Open-Label, Dose Escalation Study of the Safety and Preliminary Efficacy of EGEN-001 in Combination With Carboplatin and Docetaxel in Women With Recurrent, Platinum-Sensitive, Epithelial Ovarian Cancer
Ovarian cancer may be caused by a build-up of genetic defects, or damaged genes within the body's cells. When genes are damaged, the body may be unable to produce a group of proteins, called cytokines, used by the immune system to fight cancer and some infections. The investigational gene transfer agent EGEN-001 contains the human gene for the cytokine interleukin-12 (IL-12) in a special carrier system designed to enter the cells and help the body to produce cytokines. Therefore, the purpose of the EGEN-001 therapy is to attempt to enhance the body's natural ability to recognize and fight cancer cells. Funding Source - FDA OOPD
Read the detailed description
This study has two purposes:
- To determine what different strengths and number of doses of EGEN-001, administered directly into the peritoneal cavity, can be given safely in combination with standard intravenous chemotherapy for ovarian cancer
- To evaluate the anti-cancer activity of EGEN-001 when combined with standard chemotherapy; biological markers of EGEN-001 activity will be collected and ovarian cancer burden will be evaluated per standard practice.
- Conditions
- Ovarian Neoplasms
- Being tested
- EGEN-001 (phIL-12-005/PPC)
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGEN-001 (phIL-12-005/PPC)Genetic
In stage 1, patients will receive standard doses of IV carboplatin and docetaxel for 2 treatment cycles with a 3 week interval. Patients will also receive 4 IP infusions of EGEN-001 at 12mg/m2 EGEN-001, 18mg/m2, or 24mg/m2, 10-11 days apart.
Stage 2 of the study will involve cycle escalation at the highest EGEN-001 dose identified from Stage 1. All patients will receive up to 8 doses of EGEN-001, 10-11 days apart plus up to 4 IV carboplatin and docetaxel cycles with 3 week intervals. After receiving the assigned number of treatments of EGEN-001, carboplatin, and docetaxel, patients may continue to receive up to 4 additional infusions of EGEN-001 and 2 IV carboplatin and docetaxel cycles with 3 week intervals.
| Study group | Role | What they receive |
|---|---|---|
| EGEN-001 | Experimental | Not described Receives: Genetic: EGEN-001 (phIL-12-005/PPC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the MTD and treatment-related toxicities of intra-peritoneal (IP) infusion of EGEN-001 in combination with carboplatin and docetaxel for recurrent, platinum-sensitive, ovarian cancer.
Measured: 12-14 months
Secondary outcomes (1)
Examine the optimal EGEN-001 treatment regimen in combination with carboplatin and docetaxel in recurrent, platinum-sensitive ovarian cancer, and assess EGEN-001's impact on tumor, CA-125, and activity markers of biological activity.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2007 (estimated)
- Study startApr 2007
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- EGEN, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald D. Alvarez, MD, Principal investigator, Division of Gynecologic Oncology at University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473954
- Sponsor's protocol ID
- EGEN-001-201
- Status last verified
- Mar 2013
- First submitted
- 15 May 2007
- Last updated
- 26 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Dose Escalation Study of the Safety and Preliminary Efficacy of EGEN-001 in Combination With Carboplatin and Docetaxel in Women With Recurrent, Platinum-Sensitive, Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00473954
- Acronym / sponsor ID
- EGEN-001-201
- Conditions
- Ovarian Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- EGEN, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 16 May 2007 (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.
Ovarian cancer may be caused by a build-up of genetic defects, or damaged genes within the body's cells. When genes are damaged, the body may be unable to produce a group of proteins, called cytokines, used by the immune system to fight cancer and some infections. The investigational gene transfer agent EGEN-001 contains the human gene for the cytokine interleukin-12 (IL-12) in a special carrier system designed to enter the cells and help the body to produce cytokines. Therefore, the purpose of the EGEN-001 therapy is to attempt to enhance the body's natural ability to recognize and fight cancer cells. Funding Source - FDA OOPD
Detailed description
This study has two purposes:
- To determine what different strengths and number of doses of EGEN-001, administered directly into the peritoneal cavity, can be given safely in combination with standard intravenous chemotherapy for ovarian cancer
- To evaluate the anti-cancer activity of EGEN-001 when combined with standard chemotherapy; biological markers of EGEN-001 activity will be collected and ovarian cancer burden will be evaluated per standard practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EGEN-001 | Experimental | Genetic: EGEN-001 (phIL-12-005/PPC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Be female and at least 18 years of age (or minimum legal age and competency to provide voluntary written informed consent for study participation);
- Histologically/cytologically confirmed epithelial ovarian cancer that meets one of the following criteria:
- measurable disease by computed tomography (CT) scan or
- malignant ascites, or
- Serum CA-125 levels; or
Key exclusion criteria (21 listed)
- Ovarian cancer other than documented epithelial cancer;
- Intra-abdominal disease > 5 cm in diameter;
- Any serious, uncontrolled, intercurrent medical illness or disorder including, but not limited to:
- An active infection within 4 weeks of study entry;
- Any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration
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 |
|---|---|---|
| EGEN-001 (phIL-12-005/PPC)In stage 1, patients will receive standard doses of IV carboplatin and docetaxel for 2 treatment cycles with a 3 week interval. Patients will also receive 4 IP infusions of EGEN-001 at 12mg/m2 EGEN-001, 18mg/m2, or 24mg/m2, 10-11 days apart. Stage 2 of the study will involve cycle escalation at the highest EGEN-001 dose identified from Stage 1. All patients will receive up to 8 doses of EGEN-001, 10-11 days apart plus up to 4 IV carboplatin and docetaxel cycles with 3 week intervals. After receiving the assigned number of treatments of EGEN-001, carboplatin, and docetaxel, patients may continue to receive up to 4 additional infusions of EGEN-001 and 2 IV carboplatin and docetaxel cycles with 3 week intervals. | Genetic | EGEN-001 |
Primary outcome
Determine the MTD and treatment-related toxicities of intra-peritoneal (IP) infusion of EGEN-001 in combination with carboplatin and docetaxel for recurrent, platinum-sensitive, ovarian cancer.
Time frame: 12-14 months
1 secondary outcome
Examine the optimal EGEN-001 treatment regimen in combination with carboplatin and docetaxel in recurrent, platinum-sensitive ovarian cancer, and assess EGEN-001's impact on tumor, CA-125, and activity markers of biological activity.
Time frame: 10 months
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 26 Mar 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.
Ronald D. Alvarez, MD principal investigator
Division of Gynecologic Oncology at University of Alabama at Birmingham
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EGEN-001 (phIL-12-005/PPC) in people with Ovarian Neoplasms, run by EGEN, Inc. at 4 sites 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 14 inclusion and 21 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 26 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Determine the MTD and treatment-related toxicities of intra-peritoneal (IP) infusion of EGEN-001 in combination with carboplatin and docetaxel for recurrent, platinum-sensitive, ovarian cancer. (time frame: 12-14 months). 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 26 Mar 2013.