Ovarian CancerPhase 3HECTORNCT00437307
Hycamtin Plus Carboplatin Versus Established Regimens for the Treatment of Ovarian Cancer Relapse
A Phase 3 study testing Topotecan in people with Ovarian Cancer, run by North Eastern German Society of Gynaecological Oncology at 1 site in Germany.
Trial summary
Determination of progression free survival after 12 months of FU Determination of total survival, response and quality of life 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2007to Jun 2015
- Phase
- Phase 3
- 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
- Women ≥18 years of age with platinum-sensitive recurrent ovarian cancer occurring at least six months after completion of primary standard therapy are eligible
- Patients with measurable or assessable lesions or CA-125 ≥ 2x ULN an Eastern Co-operative Oncology Group (ECOG) performance status ≤ 2
- All patients will provide written informed consent
Who cannot join
- Patients with more than two chemotherapies in their history
- Progress less than six months after completion of primary standard therapy
- Simultaneous or planned radiation
- Any known hypersensitivity to topotecan, carboplatin, paclitaxel or gemcitabine
- Patients with infection
- Patients who are pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topotecan Plus Carboplatin im Vergleich Zur Standardtherapie (Paclitaxel Plus Carboplatin Oder Gemcitabin Plus Carboplatin) in Der Therapie Von Patientinnen Mit Platin-sensitivem Rezidivierten Epithelialen Ovarialkarzinom, Peritonealkarzinom Oder Tubenkarzinom
Determination of progression free survival after 12 months of FU
Determination of total survival, response and quality of life
Read the detailed description
In Germany there are two established therapy regimes for platin sensitive ovarian cancer: the combination of carboplatin and paclitaxel as well as the combination of carboplatin with gemcitabine. Choice of therapy is individual due to missing randomized comparisons between the regimes. Topotecan has shown good efficacy in second-line therapy of ovarian cancer as well as a good, especially, non-hematoxic toxicity profile. Several phase II-studies have demonstrated a synergistic effect of topotecan in combination with carboplatin exhibiting good efficacy and tolerability.
It shall be tested in this randomized phase III-study if the combination of topotecan and carboplatin shows improvement of progression-free survival in comparison to the standard regimes.
- 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
Also called Hycamtin
Topotecan: 0,75 mg/m²/d, day 1-3, and Carboplatin: AUC 5 (after Cockroft and Gault Formula) on day 3 after Topotecan, q 21d
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Topotecan: 0,75 mg/m²/d, Tage 1-3 und Carboplatin: AUC 5 (after Cockroft and Gault formula) am Tag 3 nach Topotecan, q 21d. Receives: Drug: Topotecan |
| 2 | No intervention | Paclitaxel 175 mg/m2/d, day 1 and Carboplatin: AUC 5 (after Cockroft and Gault formula), day 1, q21d OR gemcitabine 1000 mg/m2/d, day 1 and 8 and Carboplatin AUC 4 (after Cockroft and Gault formula), day 1, q 21d. |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: after 1 year-follow-up
Secondary outcomes (1)
overall survival, efficacy and tolerability of the regimes and quality of life
Measured: during study and follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startMar 2007
- Primary completionJul 2013
- Study completionJun 2015
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Eastern German Society of Gynaecological Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jalid Sehouli, Study chair, Charité Campus Vichow Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437307
- Sponsor's protocol ID
- 3104000
- Acronym
- HECTOR
- Status last verified
- Sep 2016
- First submitted
- 19 Feb 2007
- Last updated
- 22 Sep 2016
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topotecan Plus Carboplatin im Vergleich Zur Standardtherapie (Paclitaxel Plus Carboplatin Oder Gemcitabin Plus Carboplatin) in Der Therapie Von Patientinnen Mit Platin-sensitivem Rezidivierten Epithelialen Ovarialkarzinom, Peritonealkarzinom Oder Tubenkarzinom
- ClinicalTrials.gov ID
- NCT00437307
- Acronym / sponsor ID
- HECTOR / 3104000
- Conditions
- Ovarian Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- North Eastern German Society of Gynaecological OncologyUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 21 Feb 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.
Determination of progression free survival after 12 months of FU
Determination of total survival, response and quality of life
Detailed description
In Germany there are two established therapy regimes for platin sensitive ovarian cancer: the combination of carboplatin and paclitaxel as well as the combination of carboplatin with gemcitabine. Choice of therapy is individual due to missing randomized comparisons between the regimes. Topotecan has shown good efficacy in second-line therapy of ovarian cancer as well as a good, especially, non-hematoxic toxicity profile. Several phase II-studies have demonstrated a synergistic effect of topotecan in combination with carboplatin exhibiting good efficacy and tolerability.
It shall be tested in this randomized phase III-study if the combination of topotecan and carboplatin shows improvement of progression-free survival in comparison to the standard regimes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: TopotecanTopotecan: 0,75 mg/m²/d, Tage 1-3 und Carboplatin: AUC 5 (after Cockroft and Gault formula) am Tag 3 nach Topotecan, q 21d. |
| 2 | No intervention | –Paclitaxel 175 mg/m2/d, day 1 and Carboplatin: AUC 5 (after Cockroft and Gault formula), day 1, q21d OR gemcitabine 1000 mg/m2/d, day 1 and 8 and Carboplatin AUC 4 (after Cockroft and Gault formula), day 1, q 21d. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women ≥18 years of age with platinum-sensitive recurrent ovarian cancer occurring at least six months after completion of primary standard therapy are eligible
- Patients with measurable or assessable lesions or CA-125 ≥ 2x ULN an Eastern Co-operative Oncology Group (ECOG) performance status ≤ 2
- All patients will provide written informed consent
Key exclusion criteria (6 listed)
- Patients with more than two chemotherapies in their history
- Progress less than six months after completion of primary standard therapy
- Simultaneous or planned radiation
- Any known hypersensitivity to topotecan, carboplatin, paclitaxel or gemcitabine
- Patients with infection
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 |
|---|---|---|
| TopotecanAlso: HycamtinTopotecan: 0,75 mg/m²/d, day 1-3, and Carboplatin: AUC 5 (after Cockroft and Gault Formula) on day 3 after Topotecan, q 21d | Drug | 1 |
Primary outcome
progression-free survival
Time frame: after 1 year-follow-up
1 secondary outcome
overall survival, efficacy and tolerability of the regimes and quality of life
Time frame: during study and follow-up
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 22 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Jalid Sehouli study chair
Charité Campus Vichow Klinikum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 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 3 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 22 Sep 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
progression-free survival (time frame: after 1 year-follow-up). 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 22 Sep 2016.