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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018849-59 | EudraCT Number |
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| Name | Class |
|---|---|
| ClinAssess GmbH | INDUSTRY |
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The purpose of this trial is to estimate the therapeutic efficacy of the experimental targeted regimen including the EGFR antibody panitumumab (in combination with carboplatin and either pegylated liposomal doxorubicin or gemcitabine) in relation to the respective standard combination in patients with a KRAS wildtype with platinum-sensitive recurrent ovarian cancer. It is expected that the progression free survival rate at 12 months is improved by the targeted regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm (A): | Experimental | Caelyx 30 mg/m² d1 Carboplatin AUC 5 d1 Panitumumab 6 mg/kg/KG d1 + 15 q4w until progressive disease or for a max. of 6 cycles OR Gemcitabine 1000 mg/m² d1 + 8 Carboplatin AUC 4 d1 Panitumumab 9 mg/kg/KG d1 q3w until progressive disease or for a max. of 6 cycles The backbone chemotherapy (Caelyx or Gemcitabine-based) is specified by the investigator before randomization of a patient. |
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| Standard arm (B): | Active Comparator | Caelyx 30 mg/m² d1 Carboplatin AUC 5 d1 q4w until progressive disease or for a max. of 6 cycles OR Gemcitabine 1000 mg/m² d1 + 8 Carboplatin AUC 4 d1 q3w until progressive disease or for a max. of 6 cycles The backbone chemotherapy (Caelyx or Gemcitabine-based) is specified by the investigator before randomization of a patient. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panitumumab | Drug | Panitumumab 6 mg/kg/BW d1 + 15 q4w until progressive disease or for a max. of 6 cycles In case of CR, PR or SD at the end of the combination treatment in experimental arm, panitumumab monotherapy is to be continued with 9 mg/kg/BW d1 q3w until time of tumor progression or up to a maximum of 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) rate after 12 months. | PFS is defined as the time from randomisation to the time of disease progression or relapse (according to RECIST, not CA-125 only!) or death, or to the date of last tumor assessment without any such event (censored observation). | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Tumor-Response | according to RECIST, including measurable disease patients only, and including patients with CA-125 defined disease as well | Duration of Therapy (Therapy is planned for 6 cycles of 3 resp. 4 weeks each, shorter or longer durations are possible) |
| Progression-free survival |
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Inclusion Criteria:
Female patients with pretreated epithelial ovarian cancer, primary peritoneal carcinomatosis or fallopian tube cancer with histological confirmation of the tumor
Wild-type k-ras status
Patients must have pretreated platinum-sensitive ovarian cancer with recurrence more than 6 months after completion of a platinum-containing regimen
Presence of at least one measurable or non-measurable disease (e.g. malignant ascites) following RECIST criteria by radiologic evaluation OR histological confirmation of recurrence by biopsy. The presence of non-measurable lesions only requires in addition a 2-fold increase of CA-125 elevation above normal lab value (confirmed by two measurements).
No more than 2 prior treatment regimens for these epithelial cancers
Age > 18 years.
ECOG Performance Status of 0 or 1
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
Signed and dated informed consent before the start of specific protocol procedures.
Exclusion Criteria:
Excluded therapies and medications, previous and concomitant:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nadine Albers | Contact | 0351-25933-281 | nadine.albers@gmiho.de |
| Name | Affiliation | Role |
|---|---|---|
| Jalid Sehouli, MD (Prof. Dr. med.) | Frauenklinik Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxis Dr. Oettle | Recruiting | Friedrichshafen | Baden-Wurttemberg | 88045 | Germany |
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| pegylated liposomal doxorubicin (PLD) | Drug | pegylated liposomal doxorubicin (PLD) 30 mg/m² d1 q4w until progressive disease or for a max. of 6 cycles |
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| Carboplatin | Drug | Carboplatin AUC 5 d1 q4w until progressive disease or for a max. of 6 cycles |
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| Gemcitabine | Drug | gemcitabine 1000 mg/m² d1 + 8 q3w until progressive disease or for a max. of 6 cycles |
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| Carboplatin | Drug | Carboplatin AUC 4 d1 q3w until progressive disease or for a max. of 6 cycles |
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| Panitumumab | Drug | Panitumumab 9 mg/kg/BW d1 q3w until progressive disease or for a max. of 6 cycles In case of CR, PR or SD at the end of the combination treatment in experimental arm, panitumumab monotherapy is to be continued with 9 mg/kg/BW d1 q3w until time of tumor progression or up to a maximum of 6 months. |
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| End of Follow-up (up to 1 year) |
| Overall survival | End of Follow-up (up to 1 year) |
| Maximum toxicity resp. AE grade per patient per toxicity resp. AE during therapy | Toxicities resp. (S)AE during therapy will be documented, reported and analyzed according to NCI CTC 3.0 with special focus on skin toxicity. Results are given as maximum grade per patient per toxicity resp. AE during therapy. | Duration of Therapy (Therapy is planned for 6 cycles of 3 resp. 4 weeks each, shorter or longer durations are possible) |
| Tumor Response Rate | according to RECIST, including measurable disease patients only, and including patients with CA-125 defined disease as well | Duration of Therapy (Therapy is planned for 6 cycles of 3 resp. 4 weeks each, shorter or longer durations are possible) |
| Stauferklinikum Schwäbisch Gmünd | Recruiting | Mutlangen | Baden-Wurttemberg | 73557 | Germany |
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| Carl-Thiem-Klinikum Cottbus Frauenklinik | Recruiting | Cottbus | Brandenburg | 03048 | Germany |
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| Praxis Dr. Heinrich | Recruiting | Fürstenwalde | Brandenburg | 15517 | Germany |
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| Tagesklinik Altonaer Strasse | Recruiting | Hamburg | Free and Hanseatic City of Hamburg | 20357 | Germany |
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| MVM mbH Onkologische Schwerpunktpraxis Leer | Recruiting | Leer | Lower Saxony | 26789 | Germany |
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| Universitätsfrauenklinik am Klinikum Südstadt | Withdrawn | Rostock | Mecklenburg-Vorpommern | 18059 | Germany |
| Medizinisches Zentrum Bonn-Friedensplatz | Recruiting | Bonn | North Rhine-Westphalia | 53111 | Germany |
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| Klinikum Chemnitz Frauen- und Kinderklinik | Recruiting | Chemnitz | Saxony | 09116 | Germany |
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| Martin-Luther-Universität Halle-Wittenberg Zentrum für Frauenheilkunde und Geburtshilfe | Recruiting | Halle | Saxony-Anhalt | 06120 | Germany |
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| Klinikum Magdeburg | Recruiting | Magdeburg | Saxony-Anhalt | 39130 | Germany |
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| Praxisklinik Frauenheilkunde | Recruiting | Berlin | State of Berlin | 10367 | Germany |
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| Helios Klinikum Berlin - Buch | Withdrawn | Berlin | State of Berlin | 13125 | Germany |
| Frauenklinik Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum | Recruiting | Berlin | State of Berlin | 13353 | Germany |
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| Ev. Waldkrankenhaus Spandau | Recruiting | Berlin | State of Berlin | 13589 | Germany |
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| Praxis Dr. Schilling / Till / Kohn FÄ f. Gynäkologie u. Geburtshilfe, Gynäkol.-Onkol. Schwerpunktpraxis | Recruiting | Berlin | 10317 | Germany |
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| Gynäkologische Praxis Dr. med. Ruhmland | Recruiting | Berlin | 12683 | Germany |
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| Park-Klinik Weißensee | Recruiting | Berlin | 13086 | Germany |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| C506643 | liposomal doxorubicin |
| D016190 | Carboplatin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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