Ovarian CancerPhase 1/2NCT00886717
Paclitaxel-Loaded Polymeric Micelle and Carboplatin as First-Line Therapy in Treating Patients With Advanced Ovarian Cancer
A Phase 1/2 study testing carboplatin and paclitaxel-loaded polymeric micelle in people with Ovarian Cancer, run by Asan Medical Center at 4 sites in South Korea.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel-loaded polymeric micelle and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- carboplatin and paclitaxel-loaded polymeric micelle
- How many people
- 74 participants
- Where
- 4 sitesSouth Korea
- Study dates
- May 2008to not given
- Phase
- Phase 1/2
- 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
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed advanced ovarian cancer
- Measurable disease by RECIST criteria
- No prior or concurrent CNS metastasis
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 6 months
- Clinically acceptable blood, kidney, and spleen function
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No preexisting sensory or motor neuropathy ≥ grade 1
- No other malignancies within the past 5 years
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for ovarian cancer
- No prior immunotherapy or hormonal therapy for ovarian cancer
- No prior radiotherapy to the pelvis or abdominal cavity
- More than 2 weeks since prior major surgery other than debulking surgery
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites, 4 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Contact Person, 82-2-763-5110
- Recruiting
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, 120-752
Contact Person, 82-2-392-5594
- Recruiting
Samsung Medical Center
Seoul, 135-710
Contact Person, 82-2-3410-0200
- Recruiting
Asan Medical Center - University of Ulsan College of Medicine
Seoul, 138-736
Yong Man Kim, MD, PhD, 82-2-3010-3640
About this study
Official title: Open-label, Multicenter, Phase I/II Trial to Evaluate Efficacy Safety of the Combination Therapy of Genexol-PM and Carboplatin as a Firstline Treatment in Subjects With Advanced Ovarian Cancer
RATIONALE: Drugs used in chemotherapy, such as paclitaxel-loaded polymeric micelle and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel-loaded polymeric micelle and carboplatin and to see how well they work as first-line therapy in treating patients with advanced ovarian cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and recommended phase II dose of paclitaxel-loaded polymeric micelle and carboplatin as first-line therapy in patients with advanced ovarian cancer. (Phase I)
- Evaluate the efficacy of this regimen, in terms of CA-125 response rate after 6 courses of therapy. (Phase II)
Secondary
- Assess, preliminarily, the antitumor activity of this regimen, in terms of objective response rate (complete response and partial response), time to tumor progression, and progression-free survival, in these patients. (Phase I)
- Evaluate the safety profiles of this regimen in these patients. (Phase I)
- Determine the objective response rate, as measured by RECIST criteria, in patients treated with this regimen. (Phase II)
- Determine the overall survival of patients treated with this regimen. (Phase II)
- Determine the overall response in patients treated with this regimen. (Phase II)
- Evaluate the safety and toxicity of this regimen in these patients. (Phase II)
OUTLINE: This is a multicenter study.
Patients receive paclitaxel-loaded polymeric micelle and carboplatin.
- Conditions
- Ovarian Cancer
- Being tested
- carboplatin, paclitaxel-loaded polymeric micelle
- Keywords
- stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IV ovarian epithelial cancer, stage IIIA ovarian germ cell tumor, stage IIIB ovarian germ cell tumor, stage IIIC ovarian germ cell tumor, stage IV ovarian germ cell tumor
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
paclitaxel-loaded polymeric micelleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose and recommended phase II dose (Phase I)
Efficacy, in terms of CA-125 response rate after 6 courses of therapy (Phase II)
Secondary outcomes (6)
Preliminary antitumor activity, in terms of objective response rate (complete response and partial response), time to tumor progression, and progression-free survival (Phase I)
Safety profiles (Phase I)
Objective response rate as measured by RECIST criteria (Phase II)
Overall survival (Phase II)
Overall response (Phase II)
Safety and toxicity (Phase II)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startMay 2008
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.
- More trials run by Asan Medical CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Yong Man Kim, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886717
- Sponsor's protocol ID
- AMC-UUCM-GPMOC201
- Other IDs
- CDR0000639513
- Status last verified
- Dec 2009
- First submitted
- 22 Apr 2009
- Last updated
- 2 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multicenter, Phase I/II Trial to Evaluate Efficacy Safety of the Combination Therapy of Genexol-PM and Carboplatin as a Firstline Treatment in Subjects With Advanced Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00886717
- Acronym / sponsor ID
- AMC-UUCM-GPMOC201
- Conditions
- Ovarian Cancer
- Keywords
- stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IV ovarian epithelial cancer, stage IIIA ovarian germ cell tumor, stage IIIB ovarian germ cell tumor, stage IIIC ovarian germ cell tumor, stage IV ovarian germ cell tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- May 2008
- First posted
- 23 Apr 2009 (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.
RATIONALE: Drugs used in chemotherapy, such as paclitaxel-loaded polymeric micelle and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel-loaded polymeric micelle and carboplatin and to see how well they work as first-line therapy in treating patients with advanced ovarian cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and recommended phase II dose of paclitaxel-loaded polymeric micelle and carboplatin as first-line therapy in patients with advanced ovarian cancer. (Phase I)
- Evaluate the efficacy of this regimen, in terms of CA-125 response rate after 6 courses of therapy. (Phase II)
Secondary
- Assess, preliminarily, the antitumor activity of this regimen, in terms of objective response rate (complete response and partial response), time to tumor progression, and progression-free survival, in these patients. (Phase I)
- Evaluate the safety profiles of this regimen in these patients. (Phase I)
- Determine the objective response rate, as measured by RECIST criteria, in patients treated with this regimen. (Phase II)
- Determine the overall survival of patients treated with this regimen. (Phase II)
- Determine the overall response in patients treated with this regimen. (Phase II)
- Evaluate the safety and toxicity of this regimen in these patients. (Phase II)
OUTLINE: This is a multicenter study.
Patients receive paclitaxel-loaded polymeric micelle and carboplatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 | – |
| paclitaxel-loaded polymeric micelle | Drug | – |
Primary outcome
Maximum tolerated dose and recommended phase II dose (Phase I)
Efficacy, in terms of CA-125 response rate after 6 courses of therapy (Phase II)
6 secondary outcomes
Preliminary antitumor activity, in terms of objective response rate (complete response and partial response), time to tumor progression, and progression-free survival (Phase I)
Safety profiles (Phase I)
Objective response rate as measured by RECIST criteria (Phase II)
Overall survival (Phase II)
Overall response (Phase II)
Safety and toxicity (Phase II)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 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.
Yong Man Kim, MD, PhD principal investigator
Asan Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing carboplatin and paclitaxel-loaded polymeric micelle in people with Ovarian Cancer, run by Asan Medical Center at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 2 Aug 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 South Korea. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose and recommended phase II dose (Phase I). The study lists 2 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 2 Aug 2013.