Cancer of the Ovary Treated as 2nd Line TherapyPhase 2NCT00189410
Combination Chemotherapy Consisting of Pegylated Liposomal Doxorubicin and Carboplatin in Malignant Gynecologic Tumours
A Phase 2 study testing Pegylated Liposomal Doxorubicin and Carboplatin in people with Cancer of the Ovary Treated as 2nd Line Therapy and Muellerian Mixed Tumours, run by AGO Study Group at 19 sites in Germany.
Trial summary
Pegylated Liposomal Doxorubicin as well as Carboplatin have been showed efficacy in monotherapy as in combination therapy of gynaecologic tumours. As there is no common standard in the therapy of recurrent ovarian carcinoma, tumours of the uterus nor for non-epithelial ovarian tumours at time of designing of this… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer of the Ovary Treated as 2nd Line Therapy, Muellerian Mixed Tumours, Tumours of the Uterus
- What is being tested?
- Pegylated Liposomal Doxorubicin and Carboplatin
- How many people
- 140 participants
- Where
- 19 sitesGermany
- Study dates
- Jun 2003to Sep 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
- Histologically confirmed diagnosis of a gynecologic tumour [(non-epithelial ovarian tumour without germcell-tumours, tumours of the uterus (eg. Muellerian mixed tumours, Endometrial carcinomas, Uterus sarcoma, Cancer of the cervix)]
- Target or non-target lesion. Patients with epithelial ovarian carcinoma are qualified also if they have a CA 125 increase only.
- Patients with ovarian carcinoma must have completed a platin-containing chemotherapy more than 6 months at least. Patients with other malignancies could have prior chemotherapy, but must'nt
- Prior Radiotherapy less than 25% of haemapoietic system is allowed, but should have completed at least 6 weeks prior or registration
- Prior antitumoral hormone therapy, or specific immunotherapy is allowed, treatment have to be completed at least 3 weeks prior of registration
- All women with childbearing potential have to be a negative pregnancy test within 7 days of registration
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- Perfomance Status 0-2 ECOG or more than 60% according to Karnofsky Index
- Estimated expectancy of life of more than 12 weeks
- adequate hematologic, renal and hepatic function according to following definitions: absolute Neutrophils >= 1,5 n/L Platelets >= 100 n/L Bilirubine <= 1,25 x ULN estimated glomerular filtration rate (Jelliffe) >= 60 ml/min
- Patients who have given their signed and written informed consent to participate in the trial
- Patients must be geographically accessible for treatment and follow
Who cannot join
- More than 2 prior chemotherapies (or Radio-Chemotherapies)
- active infection or concurrent severe medical problems unrelated to malignancy which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
- application of other cytotoxic or antitumoral agents during study period
- Patients with a history of seizure disorder or central nervous system disorders
- History of congestive heart failure (NYHA Classification > 2, even if medically controlled.
- History of clinical and electrocardiographically documented myocardial infarction within the last 6 months.
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- History of atrial or ventricular arrhythmias (> LOWN II)
- Women who are pregnant or breast feeding
- Fertile women not using adequate contraceptive measures
- Patients who have used any investigational drugs within 30 days of study entry
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Germany19 sites
Medical Practice Dr. Klare
Berlin, 10367
Evangelisches Krankenhaus, Dept. of Gynecology & Obstetrics
Düsseldorf, 40217
Univerisity Hospital; Dept. of Gynecology & Obstetrics
Erlangen, 91054
University hospital, Dept. of gynecology & obstetrics
Essen, 45122
University hospital , Dept. gynecologic & obestretics
Frankfurt, 60596
University of Freiburg; Dept of Gynecology & Obstetrics
Freiburg im Breisgau, 79106
Ernst-Moritz-Arndt University, Dept. of Gynecology & Obstetrics
Greifswald, 17487
MH Hannover, Dept. of Gynecology & Obstetrics
Hanover, 30625
St. Vincentius Hospital, Dept. of Gynecology & Obstetrics
Karlsruhe, 76137
Univerisity Clinic Schleswig-Holstein, Campus Kiel, Dept. for gynecology & obstetrics
Kiel, 24105
Otto-von-Guericke Univerisity, Dept. of Gynecology & Obstetrics
Magdeburg, 39108
University hospital, Dept. of Gynecology & Obstetrics
Mainz, 55101
Phillips University, Clinic fo gynecology, gyn endocrinology and oncology
Marburg, 35033
University hospital Muenchen-Grosshadern, Dept. of gynecology & obstetrics
München, 81377
University Hospital TU Muenchen; Dept. of Gynecology & Obstetrics
München, 81675
Humaine Vogtlandklinikum; Dept. of gynecology & obstetrics
Plauen, 08529
University hospital, Dept. gynecology & obstetrics
Tübingen, 72076
Schwarzwald-Baar Klinikum Villingen, Dept. Gynecology
Villingen-Schwenningen, 78050
HSK, Dr. Horst Schmidt Klinik, Dept. of Gynecology & Gyn. Oncology
Wiesbaden, D-65199
About this study
Official title: Phase II Trial With Combination Chemotherapy Consisting of Pegylated Liposomal Doxorubicin (PLD) and Carboplatin in Malignant Gynecologic Tumour's
Pegylated Liposomal Doxorubicin as well as Carboplatin have been showed efficacy in monotherapy as in combination therapy of gynaecologic tumours. As there is no common standard in the therapy of recurrent ovarian carcinoma, tumours of the uterus nor for non-epithelial ovarian tumours at time of designing of this study, this trial shall evaluate the new and well tolerated combination therapy consisting of Pegylated Liposomal Doxorubicin and Carboplatin.
Read the detailed description
Aim of these study is the evaluation of combination chemotherapy in a patient subset with gynecologic tumours on regard to tolerance and efficacy.
- Conditions
- Cancer of the Ovary Treated as 2nd Line Therapy, Muellerian Mixed Tumours, Tumours of the Uterus, Cervical Cancers, Non-Epithelial Ovarian Tumours
- Being tested
- Pegylated Liposomal Doxorubicin and Carboplatin
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated Liposomal Doxorubicin and CarboplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance
Response Rate mainly in malignant uterine tumours
Secondary outcomes (2)
Time to Progression mainly in malignant uterine tumours
Overall Survival mainly in malignant uterine tumours
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 startJun 2003
- Primary completionSep 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of the Ovary Treated as 2nd Line TherapyStudies 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGO Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- MedServ. GmbH, Wiesbaden, Essex Pharma GmbH
- Investigators
- Andreas du Bois, MD PhD, Principal investigator, AGO-OVAR, AGO Ovarian Cancer Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189410
- Sponsor's protocol ID
- AGO-GYN 3
- Status last verified
- Jul 2010
- First submitted
- 12 Sep 2005
- Last updated
- 20 Jul 2010
- Results posted
- No
Publications
Gropp M, du Bois A, Burges A, Meier W. Combination of Pegliposomal Doxorubicin (PLD) and Carboplatin in gynecologic tumors - An AGO Study Group Phase I/II trial. Int J Gycecol Cancer 2003:13 Suppl 1, p 112
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial With Combination Chemotherapy Consisting of Pegylated Liposomal Doxorubicin (PLD) and Carboplatin in Malignant Gynecologic Tumour's
- ClinicalTrials.gov ID
- NCT00189410
- Acronym / sponsor ID
- AGO-GYN 3
- Conditions
- Cancer of the Ovary Treated as 2nd Line Therapy, Muellerian Mixed Tumours, Tumours of the Uterus, Cervical Cancers, Non-Epithelial Ovarian Tumours
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- AGO Study GroupUniversity, hospital or other
- Collaborators
- MedServ. GmbH, Wiesbaden, Essex Pharma GmbH
- Study start
- Jun 2003
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 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.
Pegylated Liposomal Doxorubicin as well as Carboplatin have been showed efficacy in monotherapy as in combination therapy of gynaecologic tumours. As there is no common standard in the therapy of recurrent ovarian carcinoma, tumours of the uterus nor for non-epithelial ovarian tumours at time of designing of this study, this trial shall evaluate the new and well tolerated combination therapy consisting of Pegylated Liposomal Doxorubicin and Carboplatin.
Detailed description
Aim of these study is the evaluation of combination chemotherapy in a patient subset with gynecologic tumours on regard to tolerance and efficacy.
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 (11 listed)
- Histologically confirmed diagnosis of a gynecologic tumour [(non-epithelial ovarian tumour without germcell-tumours, tumours of the uterus (eg. Muellerian mixed tumours, Endometrial carcinomas, Uterus sarcoma, Cancer of the cervix)]
- Target or non-target lesion. Patients with epithelial ovarian carcinoma are qualified also if they have a CA 125 increase only.
- Patients with ovarian carcinoma must have completed a platin-containing chemotherapy more than 6 months at least. Patients with other malignancies could have prior chemotherapy, but must'nt
- Prior Radiotherapy less than 25% of haemapoietic system is allowed, but should have completed at least 6 weeks prior or registration
- Prior antitumoral hormone therapy, or specific immunotherapy is allowed, treatment have to be completed at least 3 weeks prior of registration
Key exclusion criteria (10 listed)
- More than 2 prior chemotherapies (or Radio-Chemotherapies)
- active infection or concurrent severe medical problems unrelated to malignancy which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
- application of other cytotoxic or antitumoral agents during study period
- Patients with a history of seizure disorder or central nervous system disorders
- History of congestive heart failure (NYHA Classification > 2, even if medically controlled.
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 |
|---|---|---|
| Pegylated Liposomal Doxorubicin and Carboplatin | Drug | – |
Primary outcome
Tolerance
Response Rate mainly in malignant uterine tumours
2 secondary outcomes
Time to Progression mainly in malignant uterine tumours
Overall Survival mainly in malignant uterine tumours
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 20 Jul 2010.
- BackgroundGropp M, du Bois A, Burges A, Meier W. Combination of Pegliposomal Doxorubicin (PLD) and Carboplatin in gynecologic tumors - An AGO Study Group Phase I/II trial. Int J Gycecol Cancer 2003:13 Suppl 1, p 112
- Homepage of the AGO Ovarian Cancer Study GroupLink provided by the sponsor.
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.
Andreas du Bois, MD PhD principal investigator
AGO-OVAR, AGO Ovarian Cancer Study Group
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pegylated Liposomal Doxorubicin and Carboplatin in people with Cancer of the Ovary Treated as 2nd Line Therapy and Muellerian Mixed Tumours, run by AGO Study Group at 19 sites 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 11 inclusion and 10 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 20 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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?
Tolerance. 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?
On the ClinicalTrials.gov record for NCT00189410, which also lists 1 linked publication.
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 20 Jul 2010; AzTrials last refreshed its copy on 8 Nov 2026.