Feasibility and Clinical Activity of Initial Intraperitoneal Catumaxomab Followed by Chemotherapy in Patients With Recurrent Ovarian Cancer
Primary Purpose
Recurrent Epithelial Ovarian Cancer
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Catumaxomab
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Epithelial Ovarian Cancer focused on measuring recurrent epithelial ovarian cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed epithelial ovarian cancer, primary peritoneal carcinomatosis or fallopian tube cancer
- Recurrent ovarian cancer disease
- Signs for progression either measurable disease according to RECIST or CA 125 increase according the GCIG-criteria or clinical symptoms of tumor progression according to RECIST
- Radiologically and cytologically confirmed malignant ascites possible to puncture
- Life expectancy ≥ 12 weeks
- Age ≥ 18 years
- ECOG performance status at least 1
- No prior operation or, in case of prior operation, the patient must be recovered therefrom. The operation must be performed at least 4 weeks prior to start of study drug
- Capable of understanding the purposes and risks of the study, willing and able to participate in the study, and written informed consent
- Non-childbearing potential or negative pregnancy test
Exclusion Criteria:
- known brain metastases
- Concomitant cancer, chemo- or radiotherapy (except for local radiation therapy for bone marrow metastases)
- Any investigational product within 2 weeks prior to first administration of catumaxomab
- In cases of previous exposure to investigational product, cancer-, chemo-, immune- or radiotherapy (except for local radiation therapy for bone marrow metastasis):
not sufficiently recovered from previous treatment (toxicity present) based on adequate laboratory values and general status according to other in-/exclusion criteria (i.e. this might be less than 1 or 2 weeks after a weekly or bi-weekly scheduled previous therapy regimen)
- Patients must not have been exposed to nitrosoureas or mitomycin C within 6 weeks prior the first infusion of catumaxomab
- Abnormal organ or bone marrow function
- Use of immune-suppressive agents for the past 4 weeks prior to first administration of catumaxomab. For regular use of systemic corticosteroids patients should only be included after stepwise discontinuation to be free of steroids for a minimum of 5 days prior to study entry
- Any known active and chronic infection
- Known HIV infection and / or hepatitis B virus or hepatitis C virus
- Any other concurrent disease or medical conditions that are deemed to interfere with the conduct of the study as judged by the investigator
- Known or suspected hypersensitivity to catumaxomab and its analogues in general or to murine proteins (from rat or mouse)
- Known or suspected hypersensitivity to PLD, topotecan, paclitaxel, gemcitabine or their excipients.
- Patients with congestive heart failure New York Heart Association (NYHA) Class III and IV. Cardiac arrhythmias (except atrioventricular block type I and II, atrial fibrillation/flutter bundle brunch block)or other signs and symptoms of relevant cardiovascular disease
- Body mass index (BMI) < 17 (assessment after ascites drainage)
- Inadequate respiratory function in the opinion of the investigator
- Presence of complete bowel obstruction
- Patients with substance abuse, medical or psychological or social conditions which the investigator believes would preclude compliance with the study requirements.
- Unwilling or unable to follow protocol requirements
- Participation in another clinical study with experimental therapy within 14 days before start of treatment
- Legal incapacity or limited legal capacity
- Subjects housed in an institution on official or legal orders
- Pregnancy or lactation period
Sites / Locations
- Charité Campus Virchow-Klinikum
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Catumaxomab
Arm Description
Catumaxomab treatment followed by an established chemotherapy regimen
Outcomes
Primary Outcome Measures
Feasibility of close sequential combination of catumaxomab and established chemotherapy regimens
Feasibility of close sequential combination of catumaxomab and established chemotherapy regimens defined by rate of patients with at least 4 chemotherapy cycles following 4 applications of catumaxomab within 20 days as described in the scope of this clinical trial.
Secondary Outcome Measures
Number and severity of adverse events as a measure of safety and tolerability
Overall safety evaluation, including cytokine related toxicities (safety score catumaxomab
number and severity of adverse events
number of patients with AEs
occurrence of cytokine release related symptoms
hospitalization frequency and duration
changes in clinically relevant laboratory values (hematology, clinical chemistry, coagulation, and urinalysis)
Percentage of patients who can receive all 4 applications of catumaxomab within 20 days and who are able and committed to receive further mono chemotherapy
Percentage of patients who can receive all 4 applications of catumaxomab within 20 days and who are able and committed to receive further mono chemotherapy
Percentage of patients who can start chemotherapy after a maximum of 4-7 days after last catumaxomab application
Percentage of patients who can start chemotherapy after a maximum of 4-7 days after last catumaxomab application
Percentage of patients with no signs of malignant ascites at time of progression or change of therapeutic strategy
Percentage of patients with no signs of malignant ascites at time of progression or change of therapeutic strategy
Puncture-free interval (defined as paracentesis-free interval after last catumaxomab application/ removal of catheter)
Puncture-free interval (defined as paracentesis-free interval after last catumaxomab application/ removal of catheter)
Time to progression (TTP) according to RECIST and/or CA-125 response rate
Time to progression (TTP) according to RECIST and/or CA-125 response rate
Overall response rate (ORR) defined as patients with complete or partial response and duration of response (according to RECIST and/or CA-125 response)
Overall response rate (ORR) and duration of response (according to RECIST and/or CA-125 response) of second or third or fourth line chemotherapy and compare with historical data
To assess treatment free interval to subsequent therapy (defined as duration of the interval between last chemotherapy application and start of next chemotherapy
To assess treatment free interval to subsequent therapy (defined as duration of the interval between last chemotherapy application and start of next chemotherapy
To assess PFS according to RECIST and/or CA-125 response rate, OS
To assess PFS according to RECIST and/or CA-125 response rate, OS
To assess quality of life over time as defined by EORTC-QLQ C 30 and Ovar 28 questionnaire
To assess quality of life over time as defined by EORTC-QLQ C 30 and Ovar 28 questionnaire
Potential predictive clinical factors for response to catumaxomab
Analysis of potential predictive clinical factors for response to catumaxomab (e.g. amount of ascites, histology, relative lymphocyte count)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01815528
Brief Title
Feasibility and Clinical Activity of Initial Intraperitoneal Catumaxomab Followed by Chemotherapy in Patients With Recurrent Ovarian Cancer
Official Title
Single -Arm, Multicenter Phase-II Trial for Catumaxomab and Chemotherapy in Patients With Recurrent Ovarian Cancer to Investigate the Feasibility and Clinical Activity of Initial Intraperitoneal Catumaxomab Followed by Chemotherapy Regimes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
JSehouli
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Single -arm, multicenter phase-II trial for catumaxomab and chemotherapy in patients with recurrent ovarian cancer to investigate the feasibility and clinical activity of initial intraperitoneal catumaxomab followed by chemotherapy regimes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Epithelial Ovarian Cancer
Keywords
recurrent epithelial ovarian cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Catumaxomab
Arm Type
Experimental
Arm Description
Catumaxomab treatment followed by an established chemotherapy regimen
Intervention Type
Drug
Intervention Name(s)
Catumaxomab
Intervention Description
Catumaxomab dosing comprises the following four intraperitoneal (i.p.) infusions via an i.p.-port or an indwelling catheter:
10 µg on day 0
20 µg on day 3
50 µg on day 7
150 µg on day 10
Primary Outcome Measure Information:
Title
Feasibility of close sequential combination of catumaxomab and established chemotherapy regimens
Description
Feasibility of close sequential combination of catumaxomab and established chemotherapy regimens defined by rate of patients with at least 4 chemotherapy cycles following 4 applications of catumaxomab within 20 days as described in the scope of this clinical trial.
Time Frame
Approximately 5 months after start of treatment per patient
Secondary Outcome Measure Information:
Title
Number and severity of adverse events as a measure of safety and tolerability
Description
Overall safety evaluation, including cytokine related toxicities (safety score catumaxomab
number and severity of adverse events
number of patients with AEs
occurrence of cytokine release related symptoms
hospitalization frequency and duration
changes in clinically relevant laboratory values (hematology, clinical chemistry, coagulation, and urinalysis)
Time Frame
Approximately 2.5 years after start of study
Title
Percentage of patients who can receive all 4 applications of catumaxomab within 20 days and who are able and committed to receive further mono chemotherapy
Description
Percentage of patients who can receive all 4 applications of catumaxomab within 20 days and who are able and committed to receive further mono chemotherapy
Time Frame
Approximately 2.5 years after start of study
Title
Percentage of patients who can start chemotherapy after a maximum of 4-7 days after last catumaxomab application
Description
Percentage of patients who can start chemotherapy after a maximum of 4-7 days after last catumaxomab application
Time Frame
Approximately 2.5 years after start of study
Title
Percentage of patients with no signs of malignant ascites at time of progression or change of therapeutic strategy
Description
Percentage of patients with no signs of malignant ascites at time of progression or change of therapeutic strategy
Time Frame
Approximately 2.5 years after start of study
Title
Puncture-free interval (defined as paracentesis-free interval after last catumaxomab application/ removal of catheter)
Description
Puncture-free interval (defined as paracentesis-free interval after last catumaxomab application/ removal of catheter)
Time Frame
Approximately 2.5 years after start of study
Title
Time to progression (TTP) according to RECIST and/or CA-125 response rate
Description
Time to progression (TTP) according to RECIST and/or CA-125 response rate
Time Frame
Approximately 2.5 years after start of study
Title
Overall response rate (ORR) defined as patients with complete or partial response and duration of response (according to RECIST and/or CA-125 response)
Description
Overall response rate (ORR) and duration of response (according to RECIST and/or CA-125 response) of second or third or fourth line chemotherapy and compare with historical data
Time Frame
Approximately 2.5 years after start of study
Title
To assess treatment free interval to subsequent therapy (defined as duration of the interval between last chemotherapy application and start of next chemotherapy
Description
To assess treatment free interval to subsequent therapy (defined as duration of the interval between last chemotherapy application and start of next chemotherapy
Time Frame
Approximately 2.5 years after start of study
Title
To assess PFS according to RECIST and/or CA-125 response rate, OS
Description
To assess PFS according to RECIST and/or CA-125 response rate, OS
Time Frame
Approximately 2.5 years after start of study
Title
To assess quality of life over time as defined by EORTC-QLQ C 30 and Ovar 28 questionnaire
Description
To assess quality of life over time as defined by EORTC-QLQ C 30 and Ovar 28 questionnaire
Time Frame
Approximately 2.5 years after start of study
Title
Potential predictive clinical factors for response to catumaxomab
Description
Analysis of potential predictive clinical factors for response to catumaxomab (e.g. amount of ascites, histology, relative lymphocyte count)
Time Frame
Approximately 2.5 years after start of study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed epithelial ovarian cancer, primary peritoneal carcinomatosis or fallopian tube cancer
Recurrent ovarian cancer disease
Signs for progression either measurable disease according to RECIST or CA 125 increase according the GCIG-criteria or clinical symptoms of tumor progression according to RECIST
Radiologically and cytologically confirmed malignant ascites possible to puncture
Life expectancy ≥ 12 weeks
Age ≥ 18 years
ECOG performance status at least 1
No prior operation or, in case of prior operation, the patient must be recovered therefrom. The operation must be performed at least 4 weeks prior to start of study drug
Capable of understanding the purposes and risks of the study, willing and able to participate in the study, and written informed consent
Non-childbearing potential or negative pregnancy test
Exclusion Criteria:
known brain metastases
Concomitant cancer, chemo- or radiotherapy (except for local radiation therapy for bone marrow metastases)
Any investigational product within 2 weeks prior to first administration of catumaxomab
In cases of previous exposure to investigational product, cancer-, chemo-, immune- or radiotherapy (except for local radiation therapy for bone marrow metastasis):
not sufficiently recovered from previous treatment (toxicity present) based on adequate laboratory values and general status according to other in-/exclusion criteria (i.e. this might be less than 1 or 2 weeks after a weekly or bi-weekly scheduled previous therapy regimen)
Patients must not have been exposed to nitrosoureas or mitomycin C within 6 weeks prior the first infusion of catumaxomab
Abnormal organ or bone marrow function
Use of immune-suppressive agents for the past 4 weeks prior to first administration of catumaxomab. For regular use of systemic corticosteroids patients should only be included after stepwise discontinuation to be free of steroids for a minimum of 5 days prior to study entry
Any known active and chronic infection
Known HIV infection and / or hepatitis B virus or hepatitis C virus
Any other concurrent disease or medical conditions that are deemed to interfere with the conduct of the study as judged by the investigator
Known or suspected hypersensitivity to catumaxomab and its analogues in general or to murine proteins (from rat or mouse)
Known or suspected hypersensitivity to PLD, topotecan, paclitaxel, gemcitabine or their excipients.
Patients with congestive heart failure New York Heart Association (NYHA) Class III and IV. Cardiac arrhythmias (except atrioventricular block type I and II, atrial fibrillation/flutter bundle brunch block)or other signs and symptoms of relevant cardiovascular disease
Body mass index (BMI) < 17 (assessment after ascites drainage)
Inadequate respiratory function in the opinion of the investigator
Presence of complete bowel obstruction
Patients with substance abuse, medical or psychological or social conditions which the investigator believes would preclude compliance with the study requirements.
Unwilling or unable to follow protocol requirements
Participation in another clinical study with experimental therapy within 14 days before start of treatment
Legal incapacity or limited legal capacity
Subjects housed in an institution on official or legal orders
Pregnancy or lactation period
Facility Information:
Facility Name
Charité Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
12. IPD Sharing Statement
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Feasibility and Clinical Activity of Initial Intraperitoneal Catumaxomab Followed by Chemotherapy in Patients With Recurrent Ovarian Cancer
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