Patients with histologically confirmed epithelial ovarian cancer, locally advanced or metastatic without prior chemotherapy. Stage III or IV MedDRA version: 8.1 Level: LLT Classification code 10033128 Term: Ovarian cancer
Conditions
Interventions
Product Name: Lipoplatin
Product Code: Lipoplatin
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: cisplatin
CAS Number: 15663-27-1
Concentration unit: mg/ml milligram(s)/millilitre
Con
Sponsors
Regulon Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria within 30 days prior to study entry (Day 0) unless otherwise noted Adult females: over 18 years of age Patients must have a histological or cytological confirmation of advanced ovarian cancer (Stage III/IV) either locally advanced or metastatic Patients must have a performance status 0-2 (WHO) Patients with asymptomatic brain metastases are eligible Patients with brain metastases are eligible if they had a standard brain radiation therapy and they showed respone to radiation Patients with prior radiotherapy are eligible Patients must have adequate bone marrow function (defined as peripheral absolute granulocyte count of over 2,000/mm3 and platelet count of 100,000/mm3) Patients must have adequate liver function (bilirubin is less or equal to 1.5 mg/dl, SGOT, or SGPT no greater than 4 times normal) Patients must have adequate renal function (creatinine less than 1.5 mg/dl). All patients must have a life expectancy of at least 3 months Patients must understand and sign an informed consent document that explains the neoplastic nature of his/her disease, the procedures to be followed, the experimental nature of the treatment, alternative treatments, and potential risks and toxicities. 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
Exclusion criteria: Less than 3 weeks since prior major surgery Malnutrition (>25% weight loss). Other neoplasm Prior chemotherapy Pregnant or nursing women. Women with reproductive potential must have a negative pregnancy test and must use adequate contraception Patients with active ischemic heart disease, a recent history of myocardial infarction (within the last 6 months), history of congestive heart failure, ventricular arrythmias or other arrythmias requiring therapy Patients known to be HIV-positive Patients known to have active Hepatitis B or C (i.e. detectable HBS Antigen or HC Ab) Patients with underlying immune deficiency or history of autoimmune diseases e.g. (autoimmune neutropenia, thrombocytopenia, or hemolytic anemia; systemic lupus erythematosus, Sjogren syndrome, or scleroderma; myasthenia gravis; Goodpasture syndrome; Addison's disease, Hashimoto's thyroiditis, active Graves' disease, or other diseases which qualify as autoimmune in origin) Patients with dementia or with significantly altered mental status that would preclude to sign an informed consent Patients will be ineligible if, in the opinion of the principal or associate investigators, it is not in the best medical interest of the patient to enter this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary end point is to compare the response rate and toxicity profile and QOL of the Lipoplatin + paclitaxel combination (Arm A) versus Cisplatin + paclitaxel combination (Arm B);Secondary Objective: Secondary objectives of the study are to compare the time to tumor progression, one year survival and overall survival between the two arms.;Main Objective: The main objective of the study is to show that Lipoplatin is not inferior to cisplatin when combined with paclitaxel in first line treatment as assessed by response rate in randomized group of patients with advanced epithelial ovarian cancer (EOC) at stage III/IV but that patients in the Lipoplatin plus paclitaxel arm (Arm A) have a better toxicity profile and show a better quality of life (EORTC questionnaire) compared to patients in the cisplatin plus paclitaxel arm (Arm B). | — |
Countries
Greece
Outcome results
None listed