Ovarian CancerPhase 2NCT00170677
Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-resistant Ovarian Cancer
A Phase 2 study testing Topotecan in people with Ovarian Cancer, run by North Eastern German Society of Gynaecological Oncology at 1 site in Germany.
Trial summary
Comparison of topotecan weekly vs. topotecan day 1-5. The compatibility and activity are to be examined. 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?
- Topotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2005to Jan 2013
- 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
- patients with histologically-confirmed ovarian cancer
- relapse within 6 month after primary therapy
- primary therapy with platin and taxan
- ECOG 0-2
- >= 18 years
- leukocytes >= 3.000/ µl
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- platelet >= 100.000/ µl
- neutrophil >= 1.500/ µl
- written informed consent
Who cannot join
- earlier topotecan therapy
- simultaneous or planned radiotherapy
- secondary malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Comparison of topotecan weekly vs. topotecan day 1-5. The compatibility and activity are to be examined.
Read the detailed description
Topotecan belongs to the most effective medicaments in the therapy of relapsed platin-resistant ovarian cancer. Due to the low rate of hematological toxicities of grade 3 or 4 weekly application may be an improvement of therapy. None randomised study exists comparing a weekly topotecan application with an application on day 1-5. This study will compare the two applications in regard to: rate of complete or partial remissions, rate of toxicity, quality of life, progression free survival, overall survival.
- Conditions
- Ovarian Cancer
- Being tested
- Topotecan
- 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
Topotecan 4,0 mg/m² administered in day 1, 8 und 15 as i.v. infusion for 30 minutes. A cycle lasts 28 days.
TopotecanDrug
Topotecan 1,25 mg/m²/day, day 1-5 as i.v. infusion of 30 minutes. Repeat after 21 day.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Topotecan |
| B | Experimental | Not described Receives: Drug: Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of CR and PR in each arm
Measured: every 12 weeks
Secondary outcomes (2)
Toxicity of topotecan treatment
Measured: after each cycle
Progression-free survival of both arms
Measured: every 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJan 2013
- Study completionJan 2013
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Eastern German Society of Gynaecological Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Werner Lichtenegger, Study chair, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170677
- Sponsor's protocol ID
- 4401000
- Status last verified
- Jul 2010
- First submitted
- 13 Sep 2005
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-resistant Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00170677
- Acronym / sponsor ID
- 4401000
- Conditions
- Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- North Eastern German Society of Gynaecological OncologyUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 15 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.
Comparison of topotecan weekly vs. topotecan day 1-5. The compatibility and activity are to be examined.
Detailed description
Topotecan belongs to the most effective medicaments in the therapy of relapsed platin-resistant ovarian cancer. Due to the low rate of hematological toxicities of grade 3 or 4 weekly application may be an improvement of therapy. None randomised study exists comparing a weekly topotecan application with an application on day 1-5. This study will compare the two applications in regard to: rate of complete or partial remissions, rate of toxicity, quality of life, progression free survival, overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Topotecan |
| B | Experimental | Drug: Topotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- patients with histologically-confirmed ovarian cancer
- relapse within 6 month after primary therapy
- primary therapy with platin and taxan
- ECOG 0-2
- >= 18 years
Key exclusion criteria (3 listed)
- earlier topotecan therapy
- simultaneous or planned radiotherapy
- secondary malignancy
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 |
|---|---|---|
| TopotecanTopotecan 4,0 mg/m² administered in day 1, 8 und 15 as i.v. infusion for 30 minutes. A cycle lasts 28 days. | Drug | B |
| TopotecanTopotecan 1,25 mg/m²/day, day 1-5 as i.v. infusion of 30 minutes. Repeat after 21 day. | Drug | A |
Primary outcome
Rate of CR and PR in each arm
Time frame: every 12 weeks
2 secondary outcomes
Toxicity of topotecan treatment
Time frame: after each cycle
Progression-free survival of both arms
Time frame: every 12 weeks
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 14 May 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.
Werner Lichtenegger study chair
Charite University, Berlin, Germany
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 Topotecan in people with Ovarian Cancer, run by North Eastern German Society of Gynaecological Oncology at 1 site in Germany.
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 3 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 14 May 2014. 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 Germany. 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?
Rate of CR and PR in each arm (time frame: every 12 weeks). 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 14 May 2014.