Ovarian CarcinomaPhase 1IPNCT00474669
A Phase I Study of Intraperitoneal Hyperthermic Docetaxel
A Phase 1 study testing docetaxel in people with Ovarian Carcinoma, run by University of Louisville at 1 site in United States.
Trial summary
The primary objective is to assess the maximum tolerated dose of docetaxel administered intraperitoneally with heat at the time of second-look surgery in patients with stage II/III ovarian carcinoma. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Ovarian Carcinoma
- What is being tested?
- docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Dec 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have had a complete clinical response (negative clinical examination, CA125 and CT scan of chest, abdomen and pelvis) to front-line therapy for stage II/III ovarian, primary peritoneal or Fallopian tube carcinoma. This will have included initial surgery followed by combined IV/IP chemotherapy with cisplatin and paclitaxel. Patients must have had a minimum of three courses of IP therapy with both paclitaxel and cisplatin
- Second surgery to be performed no more than 3 months from last course of initial chemotherapy
- Age greater than 18 years and negative pregnancy if has child-bearing potential
- GOG performance status less than 2
- Medically fit for surgery
- Patients must have normal organ and marrow function as defined in the protocol hepatic function Total Bilirubin ULN AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values AST or ALT) should be used.
- Ability to understand and the willingness to sign a written informed consent document.
- The effects of docetaxel on the developing human fetus are unknown. For this reason and because taxanes are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Who cannot join
- Patients who have completed front-line therapy for ovarian cancer more than 3 months prior to HIPEC.
- Patients receiving any other investigational agents.
- Patients with stage IV disease including previous parenchymal liver disease, brain metastasis or cytologically-confirmed chest metastasis
- Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80. History of allergic reactions attributed to compounds of similar chemical or biologic composition used in this study in addition to Taxotere.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- More than grade 2 peripheral neuropathy from prior chemotherapy
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- Pregnant, breast-feeding or known to be HIV positive
- Prior malignancy other than non-melanomatous skin cancer more than 5 years ago
- No prior chemotherapy other than for front-line ovarian cancer or radiation for any reason.
- Stomatitis of any grade
- Uncontrolled intercurrent illness or other conditions that would limit compliance with study requirements should be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
About this study
Official title: A Phase I Study of Intraperitoneal Hyperthermic Docetaxel at the Time of Second Look Surgery Following Front-Line Normothermic Intraperitoneal and Intravenous Cisplatin/Paclitaxel for Patients With Stage II and III Ovarian Carcinoma
The primary objective is to assess the maximum tolerated dose of docetaxel administered intraperitoneally with heat at the time of second-look surgery in patients with stage II/III ovarian carcinoma.
Read the detailed description
This is a phase I study of intraperitoneal hyperthermic docetaxel given at the time of second look surgery following front-line normothermic intraperitoneal and intravenous cisplatin/paclitaxel for patients with stage II and III ovarian carcinoma. The primary objectives are to assess the maximum tolerated dose of docetaxel administered intraperitoneally with heat at this time and assess the toxicity and morbidity associated with this treatment. Eligible patients will have had a complete clinical response to front-line therapy.
- Conditions
- Ovarian Carcinoma
- Being tested
- docetaxel
- Keywords
- Ovarian Carcinoma
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
Docetaxel will be administered in normal-saline delivered at an inflow temperature of 42 degreesC for 90 minutes by the technique described in Appendix D of the protocol
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel | Experimental | Intraperitoneal Docetaxel administered with heat Receives: Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the MTD of docetaxel administered intraperitoneally with heat at the time of second-look surgery in patients with stage II/III ovarian carcinoma following surgery and normothermic intraperitoneal and intravenous cisplatin and paclitaxel.
Measured: 6 months-5 years
Secondary outcomes (1)
To assess the quality of life of patients treated with intraperitoneal hyperthermic chemotherapy in this setting
Measured: 6 months-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CarcinomaStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Responsible party
- Sponsor
- Investigators
- C. William Helm, MD, Principal investigator, James Graham Brown Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00474669
- Sponsor's protocol ID
- BCC-GYN-07-001
- Acronym
- IP
- Status last verified
- Jan 2018
- First submitted
- 15 May 2007
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
1 - R. Bruno, D. Hille, L. Thomas, A. Riva and L.B. Sheiner. Population Pharmacokinetics / Pharmacodynamics (PK/PD) of Docetaxel (Taxotere) in Phase II studies. Proc. ASCO, 14, 457, 1995. 2 - S. L. Beal, A.J. Boeckman and L.B. Sheiner. NONMEM version 4. User's Guide Part I to VI. University of California at San Francisco, San Francisco, 1988 - 1992.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Intraperitoneal Hyperthermic Docetaxel at the Time of Second Look Surgery Following Front-Line Normothermic Intraperitoneal and Intravenous Cisplatin/Paclitaxel for Patients With Stage II and III Ovarian Carcinoma
- ClinicalTrials.gov ID
- NCT00474669
- Acronym / sponsor ID
- IP / BCC-GYN-07-001
- Conditions
- Ovarian Carcinoma
- Keywords
- Ovarian Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Study start
- Jun 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 17 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.
The primary objective is to assess the maximum tolerated dose of docetaxel administered intraperitoneally with heat at the time of second-look surgery in patients with stage II/III ovarian carcinoma.
Detailed description
This is a phase I study of intraperitoneal hyperthermic docetaxel given at the time of second look surgery following front-line normothermic intraperitoneal and intravenous cisplatin/paclitaxel for patients with stage II and III ovarian carcinoma. The primary objectives are to assess the maximum tolerated dose of docetaxel administered intraperitoneally with heat at this time and assess the toxicity and morbidity associated with this treatment. Eligible patients will have had a complete clinical response to front-line therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel | Experimental | Drug: docetaxelIntraperitoneal Docetaxel administered with heat |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must have had a complete clinical response (negative clinical examination, CA125 and CT scan of chest, abdomen and pelvis) to front-line therapy for stage II/III ovarian, primary peritoneal or Fallopian tube carcinoma. This will have included initial surgery followed by combined IV/IP chemotherapy with cisplatin and paclitaxel. Patients must have had a minimum of three courses of IP therapy with both paclitaxel and cisplatin
- Second surgery to be performed no more than 3 months from last course of initial chemotherapy
- Age greater than 18 years and negative pregnancy if has child-bearing potential
- GOG performance status less than 2
- Medically fit for surgery
Key exclusion criteria (11 listed)
- Patients who have completed front-line therapy for ovarian cancer more than 3 months prior to HIPEC.
- Patients receiving any other investigational agents.
- Patients with stage IV disease including previous parenchymal liver disease, brain metastasis or cytologically-confirmed chest metastasis
- Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80. History of allergic reactions attributed to compounds of similar chemical or biologic composition used in this study in addition to Taxotere.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| docetaxelDocetaxel will be administered in normal-saline delivered at an inflow temperature of 42 degreesC for 90 minutes by the technique described in Appendix D of the protocol | Drug | Docetaxel |
Primary outcome
Assess the MTD of docetaxel administered intraperitoneally with heat at the time of second-look surgery in patients with stage II/III ovarian carcinoma following surgery and normothermic intraperitoneal and intravenous cisplatin and paclitaxel.
Time frame: 6 months-5 years
1 secondary outcome
To assess the quality of life of patients treated with intraperitoneal hyperthermic chemotherapy in this setting
Time frame: 6 months-5 years
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 9 Jan 2018.
- Results publication1 - R. Bruno, D. Hille, L. Thomas, A. Riva and L.B. Sheiner. Population Pharmacokinetics / Pharmacodynamics (PK/PD) of Docetaxel (Taxotere) in Phase II studies. Proc. ASCO, 14, 457, 1995. 2 - S. L. Beal, A.J. Boeckman and L.B. Sheiner. NONMEM version 4. User's Guide Part I to VI. University of California at San Francisco, San Francisco, 1988 - 1992.
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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.
C. William Helm, MD principal investigator
James Graham Brown Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing docetaxel in people with Ovarian Carcinoma, run by University of Louisville 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 8 inclusion and 11 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 9 Jan 2018. 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 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?
Assess the MTD of docetaxel administered intraperitoneally with heat at the time of second-look surgery in patients with stage II/III ovarian carcinoma following surgery and normothermic intraperitoneal and intravenous cisplatin and paclitaxel. (time frame: 6 months-5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00474669, which also lists 1 linked publication.
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 9 Jan 2018.