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

NCT ID: NCT01815528

Last Updated: 2015-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-02-28

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.

Conditions

Recurrent Epithelial Ovarian Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Catumaxomab

Catumaxomab treatment followed by an established chemotherapy regimen

Group Type: EXPERIMENTAL

Catumaxomab

Intervention Type: DRUG

Catumaxomab dosing comprises the following four intraperitoneal (i.p.) infusions via an i.p.-port or an indwelling catheter:

1. 10 µg on day 0

2. 20 µg on day 3

3. 50 µg on day 7

4. 150 µg on day 10

Interventions

Catumaxomab

Catumaxomab dosing comprises the following four intraperitoneal (i.p.) infusions via an i.p.-port or an indwelling catheter:

1. 10 µg on day 0

2. 20 µg on day 3

3. 50 µg on day 7

4. 150 µg on day 10

Intervention Type: DRUG

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):

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

JSehouli

OTHER

Sponsor Role: lead

Responsible Party

JSehouli

Prof. Dr. med. Jalid Sehouli

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Charité Campus Virchow-Klinikum

Berlin, , Germany

Countries

Germany

Other Identifiers

Cat-Ovar_2011

Identifier Type: -

Identifier Source: org_study_id