Feasibility and Clinical Activity of Initial Intraperitoneal Catumaxomab Followed by Chemotherapy in Patients With Recurrent Ovarian Cancer

Recurrent Epithelial Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01815528
• Other study ID #: Cat-Ovar_2011
• Status: Completed
• Phase: Phase 2
• First received: March 14, 2013
• Last updated: February 17, 2015
• Start date: March 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut, Langen
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms
• Recurrent Epithelial Ovarian Cancer

Intervention

Drug:
• Catumaxomab
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

Locations

Country	Name	City	State
Germany	Charité Campus Virchow-Klinikum	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
JSehouli

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Approximately 5 months after start of treatment per patient	Yes
Secondary	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)	Approximately 2.5 years after start of study	Yes
Secondary	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	Approximately 2.5 years after start of study	Yes
Secondary	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	Approximately 2.5 years after start of study	Yes
Secondary	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	Approximately 2.5 years after start of study	No
Secondary	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)	Approximately 2.5 years after start of study	No
Secondary	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	Approximately 2.5 years after start of study	Yes
Secondary	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	Approximately 2.5 years after start of study	No
Secondary	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	Approximately 2.5 years after start of study	No
Secondary	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	Approximately 2.5 years after start of study	No
Secondary	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	Approximately 2.5 years after start of study	No
Secondary	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)	Approximately 2.5 years after start of study	No