Mesenchymal TumorPhase 2NCT00815945
Multicenter Trial With PegLiposomal Doxorubicin and Carboplatin Combination Chemotherapy in Gynecological Sarcomas and Mixed Epithelial-Mesenchymal Tumors
A Phase 2 study testing PegLiposomal Doxorubicin and Carboplatin in people with Mesenchymal Tumor and Carcinosarcoma, run by AGO Study Group at 15 sites in Germany.
Trial summary
Uterine sarcomas account for less than 5% of all carcinomas of the uterine corpus. The prognosis of these patients is extremely limited. Recurrence rates of 50-60% are reported even for early-stage disease (FIGO I/II). Median overall survival is below 12 months in patients with advanced or metastatic disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mesenchymal Tumor, Carcinosarcoma, Leiomyosarcoma
- What is being tested?
- PegLiposomal Doxorubicin and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 15 sitesGermany
- Study dates
- Jun 2008to Jan 2012
- 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 documented mesenchymal or mixed epithelial-mesenchymal tumor of the ovary or uterus
- Patients with a primary diagnosis of FIGO I-IV uterine carcinosarcoma and optimum debulking (postoperative residual tumor < 1cm) may be enrolled only if cisplatin-ifosfamide combination therapy is not feasible.
- Patients with metastatic uterine carcinosarcoma may be enrolled only if Ifosfamide/Paclitaxel combination therapy is not feasible.
- Patients with metastatic leiomyosarcoma may be enrolled only if gemcitabine-docetaxel combination therapy is not feasible.
- Measurable (target lesion) tumor, evaluable (non-target lesion) tumor or histological documentation
- No more than one prior chemotherapy. Any prior platinum or anthracycline- containing chemotherapy must have been completed more than 6 months previously
Show all 20Show fewer
- Prior radiotherapy ≤ 25% of the hematopoietic system is allowed provided it took place more than 6 weeks before recruitment
- Patients are allowed to have received prior anticancer hormone therapy or specific immunotherapy. Patients must have completed these therapies at least three weeks before recruitment to the study
- All women with a theoretical possibility of pregnancy must produce a negative pregnancy test (serum or urinary) within seven days before starting treatment
- General health of 0 - 2 on the ECOG score
- At least 18 years of age
- Estimated life expectancy above 12 weeks
- At least 3 weeks since major surgery
- Appropriate hematologic, renal and hepatic function in accordance with the following definitions:
- Absolute neutrophil count (ANC) ≥ 1.5 × 109 /l
- Platelets ≥ 100 × 10 9/l
- Total bilirubin ≤ 1.25 times upper limit of normal
- Estimated GFR ≥ 50 ml/min
- LVEF > 50 %
- Informed consent must be obtained from all patients.
Who cannot join
- More than one prior chemotherapy (or radiochemotherapy)
- Active infection or other serious medical impairment liable to affect the patient's ability to receive treatment according to protocol.
- Administration of other chemotherapy drugs or other anticancer hormone treatments during the study.
- History of clinically manifest atrial or ventricular arrhythmia (> LOWN II) and congestive heart failure, even if controlled by drugs (NYHA class > II). Documented myocardial infarction within 6 months before study enrollment.
- Pregnant or breastfeeding women, or women not practicing appropriate birth control methods
- Participation in another study using experimental drugs within the last 30 days
- Any other conditions or therapies which the physician believes might put the patient at risk or impair the study objective.
- Known hypersensitivity to carboplatin or pegylated liposomal doxorubicin
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Germany15 sites
Charité, Campus Virchow Klinikum, Frauenklinik
Berlin, 13353
Malteser Krankenhaus, Gynäkologie und Geburtshilfe
Bonn, 53123
Klinikum Bremen-Mitte gGmbH, Frauenklinik
Bremen, 28177
Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Dresden, 01307
Evangelisches Krankenhaus Düsseldorf, Frauenklinik
Düsseldorf, 40217
Universitätsklinikum Essen, Frauenklinik
Essen, 45122
Klinikum der J. W. Goethe-Universität, Klinik für Gynäkologie und Geburtshilfe
Frankfurt, 60590
University Hospital Hamburg-Eppendorf
Hamburg, 20251
Gynäkologisch-onkologische Praxis
Hanover, 30177
St. Vincentius Kliniken AG, Frauenklinik
Karlsruhe, 76135
Universitätsklinikum Giessen und Marburg GmbH, Klinik für Gynäkologie, Gynäkologische Endokrinologie und Onkologie
Marburg, 35043
Klinikum Großhadern, Frauenklinik
München, 81377
Universitätsklinikum Tübingen, Frauenklinik
Tübingen, 72076
Universitätsklinikum Ulm, Universitätsfrauenklinik
Ulm, 89075
Dr. Horst Schmidt Kliniken GmbH, Klinik für Gynäkologie und gynäkologische Onkologie
Wiesbaden, 65199
About this study
Official title: Phase II Study Evaluating PegLiposomal Doxorubicin (PLD) and Carboplatin Combination Chemotherapy in Gynecological Sarcomas and Mixed Epithelial-Mesenchymal Tumors
Uterine sarcomas account for less than 5% of all carcinomas of the uterine corpus. The prognosis of these patients is extremely limited. Recurrence rates of 50-60% are reported even for early-stage disease (FIGO I/II). Median overall survival is below 12 months in patients with advanced or metastatic disease.
Ovarian carcinosarcoma is extremely rare among ovarian malignancies (< 2%). That is why there is insufficient data as a basis for establishing a gold standard. As a result, these cases tend to be treated in the same way as uterine sarcomas or epithelial ovarian malignancies in clinical practice.
Read more
On the basis of data published to date on the treatment of mixed mesenchymal-epithelial tumors, it is clear that the treatments commonly used to date have limited activity while producing clinically relevant toxicity. The regimes verified so far (Cisplatin / Ifosfamide, Ifosfamide/Paclitaxel and Gemcitabine/Docetaxel) exhibit a considerable side effect spectrum and are only rarely feasible on clinical everyday life conditions, so e. g. the rate of withdrawals due to toxicity was in a study collective of selected females treated with the last combination at 40 %. The physician has to check in every individual case if one of the above mentioned combinations is feasible. The search for alternative effective and better tolerated treatment options is essential. The toxicity data on the carboplatin-PLD combination are known, and efficacy has been identified in small cohorts.
The objective of this study is to explore the efficacy of combination PLD-carboplatin treatment in a larger patient population.
Read the detailed description
This study in patients with mesenchymal or mixed epithelial mesenchymal tumors of the ovary or uterus is designed as a prospective single-arm, open - label, multicenter phase II study to evaluate the efficacy of PegLiposomal Doxorubicin and Carboplatin combination chemotherapy.
40 patients will be recruited to receive PegLiposomal Doxorubicin (PLD) in a continuous i. v. infusion of at least 60 minutes at a dose of 40 mg/m2 on Day 1, followed by a 30-minute i. v. carboplatin infusion according to AUC 6 (formula devised by Calvert et al).
Patients will get outpatients treatment. At screening the patients' eligibility will be assessed, their baseline and demographic characteristics obtained, and baseline values for the effect variables collected. Patients with measurable lesions, non-measurable lesions or histological documentation will be included into this trial. Measurable lesion and non-measurable lesions will be documented by x-ray, ultrasound, computed tomography or MRI.
The patients' safety will be monitored during therapy until recovery of toxicities.
In patients with measurable lesions at baseline, the (post)-treatment values for effect according to the RECIST criteria will be collected as shown in table 6. CR, PR and SD have to be confirmed by a repeat measurement after an interval of at least four weeks.
Follow-up is scheduled every three months during the first two years after the end of treatment.
As from year 3 the follow-up takes place outside the study in the context of general aftercare.
- Conditions
- Mesenchymal Tumor, Carcinosarcoma, Leiomyosarcoma
- Being tested
- PegLiposomal Doxorubicin, Carboplatin
- Keywords
- leiomyosarcoma, carcinosarcoma, mixed epithelial mesenchymal tumor, endometrial stroma sarcomas, Müllerian mixed tumors, carcinosarcoma of the uterus, mesenchymal tumors of the ovary or uterus, mixed epithelial mesenchymal tumors of the ovary or uterus
- Medical subject headings
- Carcinosarcoma, Leiomyosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegLiposomal DoxorubicinDrug
Also called Caelyx
PegLiposomal Doxorubicin, intravenous, 40mg/m², every 28 days for up to 6 months
CarboplatinDrug
Carboplatin, intravenous, AUC 6, every 28 days for up to 6 months
| Study group | Role | What they receive |
|---|---|---|
| PegLiposomal Doxorubicin + Carboplatin | Experimental | Subjects will receive PegLiposomal Doxorubicin (40mg/m²) and Carboplatin (AUC6) every 28 days. Treatment period up to 6 months (therapy can be continued in case of tumor response and benefit for the patient) Receives: Drug: PegLiposomal Doxorubicin; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anticancer activity in terms of progression-free survival time (PFS)
Measured: every 3 months
Secondary outcomes (4)
Tolerability, i.e. type, frequency, severity and duration of adverse reactions (CTCAE,Version 3.0)
Measured: until recovery of toxicities
Anticancer activity in patients with measurable or evaluable disease in terms of response rates (CR, PR, SD, PD) according to RECIST criteria
Measured: six months
Overall survival
Measured: 30 months
Correlation of tumor marker CA-125 with imaging methods
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2008 (estimated)
- Study startJun 2008
- Primary completionNov 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesenchymal TumorStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGO Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Philipp Harter, MD, Principal investigator, Klinikum Essen Mitte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815945
- Sponsor's protocol ID
- AGO-GYN 7
- Status last verified
- Mar 2014
- First submitted
- 30 Dec 2008
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating PegLiposomal Doxorubicin (PLD) and Carboplatin Combination Chemotherapy in Gynecological Sarcomas and Mixed Epithelial-Mesenchymal Tumors
- ClinicalTrials.gov ID
- NCT00815945
- Acronym / sponsor ID
- AGO-GYN 7
- Conditions
- Mesenchymal Tumor, Carcinosarcoma, Leiomyosarcoma
- Keywords
- leiomyosarcoma, carcinosarcoma, mixed epithelial mesenchymal tumor, endometrial stroma sarcomas, Müllerian mixed tumors, carcinosarcoma of the uterus, mesenchymal tumors of the ovary or uterus, mixed epithelial mesenchymal tumors of the ovary or uterus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- AGO Study GroupUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jun 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 31 Dec 2008 (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.
Uterine sarcomas account for less than 5% of all carcinomas of the uterine corpus. The prognosis of these patients is extremely limited. Recurrence rates of 50-60% are reported even for early-stage disease (FIGO I/II). Median overall survival is below 12 months in patients with advanced or metastatic disease.
Ovarian carcinosarcoma is extremely rare among ovarian malignancies (< 2%). That is why there is insufficient data as a basis for establishing a gold standard. As a result, these cases tend to be treated in the same way as uterine sarcomas or epithelial ovarian malignancies in clinical practice.
On the basis of data published to date on the treatment of mixed mesenchymal-epithelial tumors, it is clear that the treatments commonly used to date have limited activity while producing clinically relevant toxicity. The regimes verified so far (Cisplatin / Ifosfamide, Ifosfamide/Paclitaxel and Gemcitabine/Docetaxel) exhibit a considerable side effect spectrum and are only rarely feasible on clinical everyday life conditions, so e. g. the rate of withdrawals due to toxicity was in a study collective of selected females treated with the last combination at 40 %. The physician has to check in every individual case if one of the above mentioned combinations is feasible. The search for alternative effective and better tolerated treatment options is essential. The toxicity data on the carboplatin-PLD combination are known, and efficacy has been identified in small cohorts.
The objective of this study is to explore the efficacy of combination PLD-carboplatin treatment in a larger patient population.
Detailed description
This study in patients with mesenchymal or mixed epithelial mesenchymal tumors of the ovary or uterus is designed as a prospective single-arm, open - label, multicenter phase II study to evaluate the efficacy of PegLiposomal Doxorubicin and Carboplatin combination chemotherapy.
40 patients will be recruited to receive PegLiposomal Doxorubicin (PLD) in a continuous i. v. infusion of at least 60 minutes at a dose of 40 mg/m2 on Day 1, followed by a 30-minute i. v. carboplatin infusion according to AUC 6 (formula devised by Calvert et al).
Patients will get outpatients treatment. At screening the patients' eligibility will be assessed, their baseline and demographic characteristics obtained, and baseline values for the effect variables collected. Patients with measurable lesions, non-measurable lesions or histological documentation will be included into this trial. Measurable lesion and non-measurable lesions will be documented by x-ray, ultrasound, computed tomography or MRI.
The patients' safety will be monitored during therapy until recovery of toxicities.
In patients with measurable lesions at baseline, the (post)-treatment values for effect according to the RECIST criteria will be collected as shown in table 6. CR, PR and SD have to be confirmed by a repeat measurement after an interval of at least four weeks.
Follow-up is scheduled every three months during the first two years after the end of treatment.
As from year 3 the follow-up takes place outside the study in the context of general aftercare.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PegLiposomal Doxorubicin + Carboplatin | Experimental | Drug: PegLiposomal Doxorubicin, Drug: CarboplatinSubjects will receive PegLiposomal Doxorubicin (40mg/m²) and Carboplatin (AUC6) every 28 days. Treatment period up to 6 months (therapy can be continued in case of tumor response and benefit for the patient) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histologically documented mesenchymal or mixed epithelial-mesenchymal tumor of the ovary or uterus
- Patients with a primary diagnosis of FIGO I-IV uterine carcinosarcoma and optimum debulking (postoperative residual tumor < 1cm) may be enrolled only if cisplatin-ifosfamide combination therapy is not feasible.
- Patients with metastatic uterine carcinosarcoma may be enrolled only if Ifosfamide/Paclitaxel combination therapy is not feasible.
- Patients with metastatic leiomyosarcoma may be enrolled only if gemcitabine-docetaxel combination therapy is not feasible.
- Measurable (target lesion) tumor, evaluable (non-target lesion) tumor or histological documentation
Key exclusion criteria (8 listed)
- More than one prior chemotherapy (or radiochemotherapy)
- Active infection or other serious medical impairment liable to affect the patient's ability to receive treatment according to protocol.
- Administration of other chemotherapy drugs or other anticancer hormone treatments during the study.
- History of clinically manifest atrial or ventricular arrhythmia (> LOWN II) and congestive heart failure, even if controlled by drugs (NYHA class > II). Documented myocardial infarction within 6 months before study enrollment.
- Pregnant or breastfeeding women, or women not practicing appropriate birth control methods
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 |
|---|---|---|
| PegLiposomal DoxorubicinAlso: CaelyxPegLiposomal Doxorubicin, intravenous, 40mg/m², every 28 days for up to 6 months | Drug | PegLiposomal Doxorubicin + Carboplatin |
| CarboplatinCarboplatin, intravenous, AUC 6, every 28 days for up to 6 months | Drug | PegLiposomal Doxorubicin + Carboplatin |
Primary outcome
Anticancer activity in terms of progression-free survival time (PFS)
Time frame: every 3 months
4 secondary outcomes
Tolerability, i.e. type, frequency, severity and duration of adverse reactions (CTCAE,Version 3.0)
Time frame: until recovery of toxicities
Anticancer activity in patients with measurable or evaluable disease in terms of response rates (CR, PR, SD, PD) according to RECIST criteria
Time frame: six months
Overall survival
Time frame: 30 months
Correlation of tumor marker CA-125 with imaging methods
Time frame: six months
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 Feb 2017.
- 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.
Philipp Harter, MD principal investigator
Klinikum Essen Mitte
15 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 PegLiposomal Doxorubicin and Carboplatin in people with Mesenchymal Tumor and Carcinosarcoma, run by AGO Study Group at 15 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 20 inclusion and 8 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 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Anticancer activity in terms of progression-free survival time (PFS) (time frame: every 3 months). 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 Feb 2017.