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

NCT01815528 | Completed Phase 2 DMC

• 1 other identifier: Cat-Ovar_2011
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Keywords

recurrent epithelial ovarian cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• Number and severity of adverse events as a measure of safety and tolerability

  Approximately 2.5 years after start of study

• 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

• 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

• 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

• Puncture-free interval (defined as paracentesis-free interval after last catumaxomab application/ removal of catheter)

  Approximately 2.5 years after start of study

Study Arms (1)

Catumaxomab

EXPERIMENTAL

Catumaxomab treatment followed by an established chemotherapy regimen

Drug: Catumaxomab

Interventions

Catumaxomab 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

Catumaxomab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• JSehouli: lead

Study Sites (1)

Charité Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

catumaxomab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. Jalid Sehouli

Study Record Dates

• First Submitted: March 14, 2013
• First Posted: March 21, 2013
• Study Start: March 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 18, 2015

Record last verified: 2015-02

Locations

DE (1)