Ovarian CancerNCT00787488
Pilot Study of IV and IP Chemotherapy Plus Abdominal Hyperthermia for Ovarian Ca
A study testing Hyperthermia in people with Ovarian Cancer, run by Mark Dewhirst.
Trial summary
This is a pilot study aimed to test the feasibility and safety of administering combination chemotherapy with paclitaxel (both intravenously and intraperitoneally) and cisplatin (intraperitoneally) plus whole abdominal hyperthermia every 3 weeks in the treatment of optimally debulked, advanced or recurrent ovarian… Read more about this study
- Who is it for?
- Ages 18 to 72 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Hyperthermia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Apr 2009
- Phase
- Interventional
- 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 to 72 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically diagnosed Stage III or Stage IV advanced, persistent, or recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer
- Optimal debulking (< 1cm residual disease) of their disease within 6 weeks of the start of the study
- Patients must have received no more than 2 prior chemotherapy regimens with at least 4 weeks since prior chemotherapy
- GOG performance status 0, 1, or 2
- Patients must have normal organ and marrow function defined as:
- absolute neutrophil count >1,500/mcL
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- platelets >100,000/mcL
- total bilirubin and creatinine <1.5 X institutional upper limit of normal(ULN)
- AST(SGOT)/ALT(SGPT)<3 X institutional ULN
Who cannot join
- Patients with biochemical recurrences or evidence of measurable disease
- Patients with suboptimal (>1 cm) residual disease
- Patients who have had chemotherapy within 4 weeks prior
- Receiving any investigational agents
- Known brain metastases
- Epithelial ovarian carcinoma of low malignant potential (borderline carcinomas)
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- Uncontrolled intercurrent illness
- Prior radiation therapy
- History of other invasive or pre-invasive malignancies (except non-melanoma skin cancer) within the past 5 years
About this study
Official title: A Pilot Study of Intravenous and Intraperitoneal Chemotherapy Plus Abdominal Hyperthermia to Treat Optimally Debulked and Recurrent Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancers
This is a pilot study aimed to test the feasibility and safety of administering combination chemotherapy with paclitaxel (both intravenously and intraperitoneally) and cisplatin (intraperitoneally) plus whole abdominal hyperthermia every 3 weeks in the treatment of optimally debulked, advanced or recurrent ovarian, primary peritoneal, and fallopian tube cancer patients.
Read the detailed description
Day 1 of each 21 day Cycle:
Paclitaxel 175 mg/m2 IV (infused over 3 hours)
Day 1 or 2 of each Cycle Adequate IV hydration with normal saline (1000 ml recommended)followed by intraperitoneal infusion of 500 ml normal saline through the IP port.
Cisplatin 75 mg/m2 reconstituted in 500 ml NS warmed to 37 degrees Celsius is infused IP (30 minute infusion)followed immediately by whole abdominal hyperthermia
Abdominal hyperthermia will be delivered using the BSD 2000 ellipse system to target temperatures of 40-42 degrees Celsius monitored via rectally and vaginally continuing for no greater than 60 minutes after maximal 30 minute warm-up phase. Total duration of hyperthermia will be no greater than 90 minutes.
Day 8:
Paclitaxel 60 mg/m2 IP. Paclitaxel will be diluted and filtered initially in 1000 ml of normal saline or D5W warmed to 37 degrees Celsius. For IP administration, the patient must receive an additional 1000 ml of normal saline degrees Celsius in the peritoneal cavity.
Cycles will be repeated every 3 weeks x 6 cycles. Patients will be followed until disease progression/recurrence or death.
- Conditions
- Ovarian Cancer
- Being tested
- Hyperthermia
- Keywords
- Ovarian, debulked, recurrent, Stage III, Stage IV
- Medical subject headings
- Ovarian Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperthermiaDevice
Every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Chemotherapy plus Hyperthermia Receives: Device: Hyperthermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity
Measured: 6 months
Secondary outcomes (1)
Clinically free of disease. Response definitions will be based on CA-125, clinical assessment, CT imaging
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startApr 2009
- Primary completionApr 2009
- Study completionApr 2009
Why it stopped: Study not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Dewhirst
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mark Dewhirst, Duke University
- Investigators
- Elizabeth Jewell, MD, Principal investigator, Duke UniversityAngeles Secord, MD, Principal investigator, Duke UniversityEllen Jones, MD, PhD, Principal investigator, Duke University Medical Center, Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787488
- Sponsor's protocol ID
- Pro00008510
- Status last verified
- Nov 2014
- First submitted
- 6 Nov 2008
- Last updated
- 11 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Intravenous and Intraperitoneal Chemotherapy Plus Abdominal Hyperthermia to Treat Optimally Debulked and Recurrent Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancers
- ClinicalTrials.gov ID
- NCT00787488
- Acronym / sponsor ID
- Pro00008510
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian, debulked, recurrent, Stage III, Stage IV
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mark DewhirstUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 7 Nov 2008 (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 is a pilot study aimed to test the feasibility and safety of administering combination chemotherapy with paclitaxel (both intravenously and intraperitoneally) and cisplatin (intraperitoneally) plus whole abdominal hyperthermia every 3 weeks in the treatment of optimally debulked, advanced or recurrent ovarian, primary peritoneal, and fallopian tube cancer patients.
Detailed description
Day 1 of each 21 day Cycle:
Paclitaxel 175 mg/m2 IV (infused over 3 hours)
Day 1 or 2 of each Cycle Adequate IV hydration with normal saline (1000 ml recommended)followed by intraperitoneal infusion of 500 ml normal saline through the IP port.
Cisplatin 75 mg/m2 reconstituted in 500 ml NS warmed to 37 degrees Celsius is infused IP (30 minute infusion)followed immediately by whole abdominal hyperthermia
Abdominal hyperthermia will be delivered using the BSD 2000 ellipse system to target temperatures of 40-42 degrees Celsius monitored via rectally and vaginally continuing for no greater than 60 minutes after maximal 30 minute warm-up phase. Total duration of hyperthermia will be no greater than 90 minutes.
Day 8:
Paclitaxel 60 mg/m2 IP. Paclitaxel will be diluted and filtered initially in 1000 ml of normal saline or D5W warmed to 37 degrees Celsius. For IP administration, the patient must receive an additional 1000 ml of normal saline degrees Celsius in the peritoneal cavity.
Cycles will be repeated every 3 weeks x 6 cycles. Patients will be followed until disease progression/recurrence or death.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: HyperthermiaChemotherapy plus Hyperthermia |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically diagnosed Stage III or Stage IV advanced, persistent, or recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer
- Optimal debulking (< 1cm residual disease) of their disease within 6 weeks of the start of the study
- Patients must have received no more than 2 prior chemotherapy regimens with at least 4 weeks since prior chemotherapy
- GOG performance status 0, 1, or 2
- Patients must have normal organ and marrow function defined as:
Key exclusion criteria (9 listed)
- Patients with biochemical recurrences or evidence of measurable disease
- Patients with suboptimal (>1 cm) residual disease
- Patients who have had chemotherapy within 4 weeks prior
- Receiving any investigational agents
- Known brain metastases
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 |
|---|---|---|
| HyperthermiaEvery 3 weeks | Device | 1 |
Primary outcome
Toxicity
Time frame: 6 months
1 secondary outcome
Clinically free of disease. Response definitions will be based on CA-125, clinical assessment, CT imaging
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2014.
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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.
Elizabeth Jewell, MD principal investigator
Duke University
Angeles Secord, MD principal investigator
Duke University
Ellen Jones, MD, PhD principal investigator
Duke University Medical Center, Radiation Oncology
Questions about this trial
What is this clinical trial studying?
A study testing Hyperthermia in people with Ovarian Cancer, run by Mark Dewhirst.
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 9 inclusion and 9 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: withdrawn, as of the sponsor's last update on 11 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Toxicity (time frame: 6 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 11 Nov 2014.