Epithelial Ovarian Cancer, Fallopian Tube or PeritoneumPhase 3NCT00189371
Reinduction Chemotherapy Containing Carboplatin and Paclitaxel With or Without Epoetin Alpha in Recurrent Platinum Sensitive Ovarian Cancer, Cancer of the Fallopian Tube or Peritoneum
A Phase 3 study testing paclitaxel, carboplatin, epoetin alpha in people with Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum and Platinum Sensitve Relapse, run by AGO Study Group at 1 site in Germany.
Trial summary
Patients with epithelial ovarian cancer, fallopian tube or peritoneal cancer who receive surgical cytoreduction and platinum/taxane containing chemotherapy have a significant chance of entering complete clinical remission but about 70% will eventually relapse. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum, Platinum Sensitve Relapse, Anemia
- What is being tested?
- paclitaxel, carboplatin, epoetin alpha
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2004to Dec 2005
- 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
- Adult, Older adult
Who may be able to join
- Relapse longer than 6 months after termination of platinum/taxane based first line chemotherapy
- Previously histologically confirmed cancer of: ovary, fallopian tube, peritoneum
- measurable and evaluable lesions by ultrasound, computer-tomography or MRI
- Performance status ECOG < 2 or karnofsky index > 60%
- normal organ function
Who cannot join
- more than 1 chemotherapy prior enrollment
- ongoing treatment with epoetin alpha or related drugs
- history of thrombosis or embolism during the past 12 months prior enrollment
- ileus
- left ventricular failure > NYHA classification > 2
- Ongoing toxicity of any kind (> CTC Grad II)
Trial locations and contacts
1 site in 1 country.
About this study
Patients with epithelial ovarian cancer, fallopian tube or peritoneal cancer who receive surgical cytoreduction and platinum/taxane containing chemotherapy have a significant chance of entering complete clinical remission but about 70% will eventually relapse. Relapse more than 6 months following first line chemotherapy is regarded as platinum/taxane sensitive disease. Reinduction chemotherapy with platinum/taxane is known to be an effective treatment option. Therapy induced anemia is a common problem resulting in decrease of quality of life. The rationale of this trail is to evaluate the effects of epoetin alpha on reduction of therapy induced anemia, rate of transfusions and on quality of life.
- Conditions
- Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum, Platinum Sensitve Relapse, Anemia
- Being tested
- paclitaxel, carboplatin, epoetin alpha
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel, carboplatin, epoetin alphaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of anemia
Secondary outcomes (4)
Quality of life
Overall survival
Progression free survival
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 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian Cancer, Fallopian Tube or PeritoneumStudies 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
- 300 participants
Sponsor and investigators
- Lead sponsor
- AGO Study Group
- Sponsor type
- University, hospital or other
- Investigators
- Christian Jackisch, MD, PhD, Principal investigator, AGO Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189371
- Sponsor's protocol ID
- AGO-OVAR 2.7
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 19 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reinduction Chemotherapy Containing Carboplatin and Paclitaxel With or Without Epoetin Alpha in Recurrent Platinum Sensitive Ovarian Cancer, Cancer of the Fallopian Tube or Peritoneum
- ClinicalTrials.gov ID
- NCT00189371
- Acronym / sponsor ID
- AGO-OVAR 2.7
- Conditions
- Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum, Platinum Sensitve Relapse, Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 300 participants
- Lead sponsor
- AGO Study GroupUniversity, hospital or other
- Study start
- Feb 2004
- Study completion
- Dec 2005
- 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.
Patients with epithelial ovarian cancer, fallopian tube or peritoneal cancer who receive surgical cytoreduction and platinum/taxane containing chemotherapy have a significant chance of entering complete clinical remission but about 70% will eventually relapse. Relapse more than 6 months following first line chemotherapy is regarded as platinum/taxane sensitive disease. Reinduction chemotherapy with platinum/taxane is known to be an effective treatment option. Therapy induced anemia is a common problem resulting in decrease of quality of life. The rationale of this trail is to evaluate the effects of epoetin alpha on reduction of therapy induced anemia, rate of transfusions and on quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Relapse longer than 6 months after termination of platinum/taxane based first line chemotherapy
- Previously histologically confirmed cancer of: ovary, fallopian tube, peritoneum
- measurable and evaluable lesions by ultrasound, computer-tomography or MRI
- Performance status ECOG < 2 or karnofsky index > 60%
- normal organ function
Key exclusion criteria (6 listed)
- more than 1 chemotherapy prior enrollment
- ongoing treatment with epoetin alpha or related drugs
- history of thrombosis or embolism during the past 12 months prior enrollment
- ileus
- left ventricular failure > NYHA classification > 2
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 |
|---|---|---|
| paclitaxel, carboplatin, epoetin alpha | Drug | – |
Primary outcome
Reduction of anemia
4 secondary outcomes
Quality of life
Overall survival
Progression free survival
Toxicity
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2005.
- homepage of the german ovarian cancer study group AGOLink 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.
Christian Jackisch, MD, PhD principal investigator
AGO Study Group
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 paclitaxel, carboplatin, epoetin alpha in people with Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum and Platinum Sensitve Relapse, run by AGO Study Group 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 5 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: stopped early, as of the sponsor's last update on 19 Sep 2005. 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 was stopped early. Results are not available in the source record.
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?
Reduction of anemia. 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 Sep 2005.