Ovary CancerPhase 2NCT00193297
Topotecan Plus Paclitaxel and Carboplatin in the Initial Treatment of Advanced Ovarian and Primary Peritoneal Carcinoma
A Phase 2 study testing Topotecan, Paclitaxel and Carboplatin in people with Ovary Cancer, run by SCRI Development Innovations, LLC.
Trial summary
The purpose of this study is to evaluate the feasibility and toxicity of the combination of paclitaxel, carboplatin, and topotecan in patients with previously untreated, stage III or IV epithelial ovarian carcinoma or primary peritoneal carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovary Cancer
- What is being tested?
- Topotecan, Paclitaxel and Carboplatin
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2002to Jun 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be included in this study, you must meet the following criteria:
- Epithelial ovarian carcinoma or primary peritoneal carcinoma
- Willing to consider second-look surgery to evaluate response if necessary
- No previous treatment with chemotherapy or radiation therapy
- Ability to perform activities of daily living with minimal assistance
- Adequate bone marrow, liver and kidney function
- Written informed consent
Who cannot join
- You cannot participate in this study if any of the following apply to you:
- Age < 18 years
- Brain metastases
- Recent history of significant heart disease within 6 months
- Other significant medical conditions
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
About this study
Official title: A Phase II Study of a Three-Day Schedule of Topotecan Plus Paclitaxel and Carboplatin on Day Three in the Initial Treatment of Advanced Ovarian and Primary Peritoneal Carcinoma
The purpose of this study is to evaluate the feasibility and toxicity of the combination of paclitaxel, carboplatin, and topotecan in patients with previously untreated, stage III or IV epithelial ovarian carcinoma or primary peritoneal carcinoma. We will also make a preliminary evaluation of the efficacy of this three drug regimen in the initial treatment of these patients.
Read the detailed description
Upon determination of eligibility, all patients will be receive:
Paclitaxel + Carboplatin + Topotecan
a maximum of six courses of chemotherapy will be given at 21 day intervals
- Conditions
- Ovary Cancer
- Being tested
- Topotecan, Paclitaxel, Carboplatin
- Keywords
- Ovary Cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopotecanDrug
PaclitaxelDrug
CarboplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Secondary outcomes (1)
Overall toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startFeb 2002
- Primary completionJun 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovary 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Anthony Greco, MD, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00193297
- Sponsor's protocol ID
- SCRI GYN 08
- Other IDs
- 104864-644
- Status last verified
- May 2011
- First submitted
- 12 Sep 2005
- Last updated
- 3 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of a Three-Day Schedule of Topotecan Plus Paclitaxel and Carboplatin on Day Three in the Initial Treatment of Advanced Ovarian and Primary Peritoneal Carcinoma
- ClinicalTrials.gov ID
- NCT00193297
- Acronym / sponsor ID
- SCRI GYN 08
- Conditions
- Ovary Cancer
- Keywords
- Ovary Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Feb 2002
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 19 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 evaluate the feasibility and toxicity of the combination of paclitaxel, carboplatin, and topotecan in patients with previously untreated, stage III or IV epithelial ovarian carcinoma or primary peritoneal carcinoma. We will also make a preliminary evaluation of the efficacy of this three drug regimen in the initial treatment of these patients.
Detailed description
Upon determination of eligibility, all patients will be receive:
Paclitaxel + Carboplatin + Topotecan
a maximum of six courses of chemotherapy will be given at 21 day intervals
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
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Epithelial ovarian carcinoma or primary peritoneal carcinoma
- Willing to consider second-look surgery to evaluate response if necessary
- No previous treatment with chemotherapy or radiation therapy
- Ability to perform activities of daily living with minimal assistance
- Adequate bone marrow, liver and kidney function
Key exclusion criteria (6 listed)
- Age < 18 years
- Brain metastases
- Recent history of significant heart disease within 6 months
- Other significant medical conditions
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
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 |
|---|---|---|
| Topotecan | Drug | – |
| Paclitaxel | Drug | – |
| Carboplatin | Drug | – |
Primary outcome
Overall response rate
1 secondary outcome
Overall toxicity
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 3 May 2011.
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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.
Anthony Greco, MD principal investigator
SCRI Development Innovations, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topotecan, Paclitaxel and Carboplatin in people with Ovary Cancer, run by SCRI Development Innovations, LLC.
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 7 inclusion and 6 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 3 May 2011. 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.
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?
Overall response rate. 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 3 May 2011.