Ovarian CarcinomaPhase 2NCT00214058
Weekly Carboplatin/Docetaxel for Recurrent Ovarian/Peritoneal Cancer
A Phase 2 study testing Carboplatin and Docetaxel in people with Ovarian Carcinoma and Primary Peritoneal Carcinoma, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of this regimen in women with ovarian or peritoneal cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Carcinoma, Primary Peritoneal Carcinoma
- What is being tested?
- Carboplatin and Docetaxel
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Feb 2006
- 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
- Adult, Older adult
Who may be able to join
- Recurrent ovarian or peritoneal cancer
Who cannot join
- No prior chemotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: Phase II Evaluation of Weekly Docetaxel in Combination With Weekly Carboplatin in the Treatment of Recurrent Epithelial Ovarian Carcinoma
The purpose of this study is to determine the safety and efficacy of this regimen in women with ovarian or peritoneal cancer
- Conditions
- Ovarian Carcinoma, Primary Peritoneal Carcinoma
- Being tested
- Carboplatin, Docetaxel
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
DocetaxelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Efficacy
Secondary outcomes (1)
QOL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startAug 2002
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- David M Kushner, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214058
- Sponsor's protocol ID
- CO02701
- Other IDs
- 2002-224, A532820, SMPH/OBSTET & GYNECOL
- Status last verified
- Jun 2008
- First submitted
- 13 Sep 2005
- Last updated
- 19 Nov 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Evaluation of Weekly Docetaxel in Combination With Weekly Carboplatin in the Treatment of Recurrent Epithelial Ovarian Carcinoma
- ClinicalTrials.gov ID
- NCT00214058
- Acronym / sponsor ID
- CO02701
- Conditions
- Ovarian Carcinoma, Primary Peritoneal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Study start
- Aug 2002
- Study completion
- Feb 2006 (actual)
- First posted
- 21 Sep 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.
The purpose of this study is to determine the safety and efficacy of this regimen in women with ovarian or peritoneal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Recurrent ovarian or peritoneal cancer
Key exclusion criteria (1 listed)
- No prior chemotherapy
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 |
|---|---|---|
| Carboplatin | Drug | – |
| Docetaxel | Drug | – |
Primary outcome
Safety and Efficacy
1 secondary outcome
QOL
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 19 Nov 2019.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
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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.
David M Kushner, MD principal investigator
University of Wisconsin, Madison
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 Carboplatin and Docetaxel in people with Ovarian Carcinoma and Primary Peritoneal Carcinoma, run by University of Wisconsin, Madison 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 1 inclusion and 1 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 19 Nov 2019. 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?
Safety and Efficacy. 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 19 Nov 2019.