Carboplatin-based Chemotherapy With or Without Panitumumab in Platinum-sensitive Recurrent Ovarian Cancer
NCT ID: NCT01388621
Last Updated: 2013-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
140 participants
INTERVENTIONAL
2011-10-31
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental arm (A):
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.
Panitumumab
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.
pegylated liposomal doxorubicin (PLD)
pegylated liposomal doxorubicin (PLD) 30 mg/m² d1 q4w until progressive disease or for a max. of 6 cycles
Carboplatin
Carboplatin AUC 5 d1 q4w until progressive disease or for a max. of 6 cycles
Gemcitabine
gemcitabine 1000 mg/m² d1 + 8 q3w until progressive disease or for a max. of 6 cycles
Carboplatin
Carboplatin AUC 4 d1 q3w until progressive disease or for a max. of 6 cycles
Panitumumab
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.
Standard arm (B):
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.
pegylated liposomal doxorubicin (PLD)
pegylated liposomal doxorubicin (PLD) 30 mg/m² d1 q4w until progressive disease or for a max. of 6 cycles
Carboplatin
Carboplatin AUC 5 d1 q4w until progressive disease or for a max. of 6 cycles
Gemcitabine
gemcitabine 1000 mg/m² d1 + 8 q3w until progressive disease or for a max. of 6 cycles
Carboplatin
Carboplatin AUC 4 d1 q3w until progressive disease or for a max. of 6 cycles
Interventions
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Panitumumab
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.
pegylated liposomal doxorubicin (PLD)
pegylated liposomal doxorubicin (PLD) 30 mg/m² d1 q4w until progressive disease or for a max. of 6 cycles
Carboplatin
Carboplatin AUC 5 d1 q4w until progressive disease or for a max. of 6 cycles
Gemcitabine
gemcitabine 1000 mg/m² d1 + 8 q3w until progressive disease or for a max. of 6 cycles
Carboplatin
Carboplatin AUC 4 d1 q3w until progressive disease or for a max. of 6 cycles
Panitumumab
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
* Hemoglobin \> 9.0 g/dl
* Leukocyte count \>3.000/mm3 ; absolute neutrophil count (ANC) \>1.500/mm3
* Platelet count ≥ 100.000/μl
* Total bilirubin \< 1,0 times the upper limit of normal
* ALT and AST \< 2,5 x upper limit of normal (\< 5 x upper limit of normal for patients with liver involvement of their cancer)
* Alkaline phosphatase \< 4 x ULN
* PT-INR/PTT \< 1.5 x upper limit of normal \[Patients who are being therapeutically anticoagulated with an agent such as coumarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.\]
* Serum creatinine \< 1.5 x upper limit of normal and creatinine clearance \> 50 ml/min.
* Magnesium ≥ lower limit of normal; calcium ≥ lower limit of normal
* Signed and dated informed consent before the start of specific protocol procedures.
Exclusion Criteria
* History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
* History of HIV infection or chronic hepatitis B or C
* Active clinically serious infections (\> grade 2 NCI-CTC version 3.0)
* Pre-existing neuropathy \> grade 1 (NCI CTCAE), except for loss of tendon reflex
* Prior radiological or clinical evidence of CNS metastases including previously treated, resected, or asymptomatic brain lesions or leptomeningeal involvement by head CT scan or MRI
* Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
* History of organ allograft
* Patients with evidence or history of bleeding diathesis
* Patients undergoing renal dialysis
* Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors \[Ta, Tis \& T1\] or any cancer curatively treated \> 3 years prior to study entry.
* Patients in a closed institution according to an authority or court decision
* Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
Excluded therapies and medications, previous and concomitant:
* Anticancer chemotherapy within 4 weeks prior to study entry.
* Prior anti-EGFR therapy
* Radiotherapy during study or within 4 weeks of start of study drug. (Palliative radiotherapy of non-target lesions will be allowed) and prior radiotherapy of \> 25% of the bone marrow
* Major surgery within 4 weeks of start of study
* Autologous bone marrow transplant or stem cell rescue within 12 months of study
* Investigational drug therapy outside of this trial during or within 4 weeks of study entry
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
18 Years
FEMALE
No
Sponsors
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ClinAssess GmbH
INDUSTRY
WiSP Wissenschaftlicher Service Pharma GmbH
OTHER
Responsible Party
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Principal Investigators
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Jalid Sehouli, MD (Prof. Dr. med.)
Role: PRINCIPAL_INVESTIGATOR
Frauenklinik Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum
Locations
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Praxis Dr. Oettle
Friedrichshafen, Baden-Wurttemberg, Germany
Stauferklinikum Schwäbisch Gmünd
Mutlangen, Baden-Wurttemberg, Germany
Carl-Thiem-Klinikum Cottbus Frauenklinik
Cottbus, Brandenburg, Germany
Praxis Dr. Heinrich
Fürstenwalde, Brandenburg, Germany
Tagesklinik Altonaer Strasse
Hamburg, City state of Hamburg, Germany
MVM mbH Onkologische Schwerpunktpraxis Leer
Leer, Lower Saxony, Germany
Universitätsfrauenklinik am Klinikum Südstadt
Rostock, Mecklenburg-Vorpommern, Germany
Medizinisches Zentrum Bonn-Friedensplatz
Bonn, North Rhine-Westphalia, Germany
Klinikum Chemnitz Frauen- und Kinderklinik
Chemnitz, Saxony, Germany
Martin-Luther-Universität Halle-Wittenberg Zentrum für Frauenheilkunde und Geburtshilfe
Halle, Saxony-Anhalt, Germany
Klinikum Magdeburg
Magdeburg, Saxony-Anhalt, Germany
Praxisklinik Frauenheilkunde
Berlin, State of Berlin, Germany
Helios Klinikum Berlin - Buch
Berlin, State of Berlin, Germany
Frauenklinik Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum
Berlin, State of Berlin, Germany
Ev. Waldkrankenhaus Spandau
Berlin, State of Berlin, Germany
Praxis Dr. Schilling / Till / Kohn FÄ f. Gynäkologie u. Geburtshilfe, Gynäkol.-Onkol. Schwerpunktpraxis
Berlin, , Germany
Gynäkologische Praxis Dr. med. Ruhmland
Berlin, , Germany
Park-Klinik Weißensee
Berlin, , Germany
Countries
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Central Contacts
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Other Identifiers
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2010-018849-59
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GMIHO-008/2009_AG56
Identifier Type: -
Identifier Source: org_study_id