An open–label Phase 2 Trial of Pegylated Liposomal Doxorubicin and rIL-21 in Ovarian Cancer Patients with Persistent or Progressive Disease after, or Relapse within One Year of, Completion of Standard First Line Therapy

Phase 1

• Conditions: advanced epithelial Ovarian Cancer stage IIB-IV; MedDRA version: 9.1Level: LLTClassification code 10033162Term: Ovarian epithelial cancer stage II; MedDRA version: 9.1Level: LLTClassification code 10033163Term: Ovarian epithelial cancer stage III; MedDRA version: 9.1Level: LLTClassification code 10033164Term: Ovarian epithelial cancer stage IV

• Registration Number: EUCTR2007-001506-25-FR
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-11
• Study Completion: 2009-01-07
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1.Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
2.Advanced epithelial OC (stage IIB-IV), histologically confirmed according to AJCC (3)
3.Persistent or progressive disease after or relapse within 1 year of completion of first line platinum-containing chemotherapy
4.At least 1 measurable lesion = 5 cm in the largest diameter according to RECIST criteria or assessable disease defined as: a one-dimensional measurable lesion, mass with margins not clearly defined, lesions with both diameters 0.5 cm or less on radiographic imaging, palpable lesions under 2 cm or malignant ascites respectively combined with a 2 x UNL (in the absence of cirrhosis) of CA-125 measured within 2 weeks prior to inclusion in the trial.
5.18 years of age or above
6.ECOG performance status = 2
7.Haematopoietic and renal:
a.White blood cell (WBC) = 2.5 x 10^9/L
b.Absolute neutrophil count (ANC) = 1.5 x 10^9/L

c.Platelet count = 100 x 10^9/L

d.Haemoglobin = 6.2 mmol/L
e.Lymphocytes = 0.8 x 10^9/L

f.No signs of haemolytic anaemia
g.Serum-creatinine = 177 µmol/L
8.Hepatic
a.Bilirubin = 1.2 x UNL
b.ALAT and ASAT/SGOT = 2.5 x UNL (if liver metastasis then = 4 x UNL)
c.LDH = 2 x UNL

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.More than one prior chemotherapy regimen
2.First-line chemotherapy within 1 month prior to enrolment
3.Radiotherapy less than 4 weeks prior to start of treatment for bone metastasis and less than 8 weeks for visceral metastasis
4.Previous mediastinal or left thoracic irradiation
5.Bulky disease defined as 1 or more lesions > 5 cm in the largest diameter according to RECIST criteria
6.Documented positive serologic testing for hepatitis B or C within a year prior to start of treatment
7.History of or active presence of auto-immune diseases (except vitiligo and treated pernicious anaemia)
8.History of any other active malignancy (except basal cell carcinoma of the skin and cervical cancer in situ) within 5 years prior to enrolment
9.Left ventricular ejection fraction < 0.50, determined by Multigated Acquisition (MUGA) or echocardiography
10.Cardiac disease within the last 12 months defined as:
a.Decompensate heart failure (New York Heart Association (NYHA) class III or IV
b.Unstable angina pectoris
c.Myocardial infarction
11.Signs of CNS metastasis: either known brain metastasis or symptoms of brain metastasis
12.Known chronic infectious disease including human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related illness
13.Any significant systemic disease which according to the investigator could compromise the safety of the subject or interfere with the trial objectives
14.Concurrent treatment with systemic corticosteroids (topical or inhaled corticosteroid treatment is permitted)
15.Known or suspected allergy to trial product or related products
16.Previous participation (treatment) in this trial
17.Concurrent participation in any other trial with experimental therapy
18.Pregnant or the intention of becoming pregnant or not using adequate contraceptive measures (Adequate contraception includes: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified