Health Condition 1: null- Ovarian Cancer
Conditions
Interventions
Intervention1: Doxorubicin Hydrochloride Liposome Injection (MM 436): Doxorubicin Hydrochloride Liposome Injection (MM 436) single dose vials of 50 mg/25 mL(2mg/ml).
Dose- 50 mg/m2, Frequency- In ever
Sponsors
Watson Pharma Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: a) Have cytological or histological confirmation of locally advanced/metastatic or recurrent epithelial ovarian cancer b) Have evidence of recurrent or persistent disease following primary chemotherapy with a platinum based agent c) Patients with life expectancy of at least 3 months d) Have adequate organ functions, as measured by: • Absolute neutrophil count >1500 cell/mcl (unsupported by growth factors) • Hemoglobin >9.0 g/dl • Platelet count >100,000/mcl • Creatinine • Total bilirubin • ALT/AST e) Have a baseline LVEF by ECHO/MUGA >= 50% f) Discontinued all steroids and all antiâ??convulsive agents for at least three months since definitive treatment of their brain metastases (for patients with previously diagnosed brain metastases) g) Have an ECOG PS of 0â??2 h) Be willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of study drug (for example an effective form of contraception is abstinence, an oral contraceptive, or a double barrier method etc.). i) Able to comply with study requirement in opinion of Principal Investigator
Exclusion criteria
Exclusion criteria: a) Is HIV/HBsAg(including B and C virus) / Syphilis positive b) Has a known intolerance to doxorubicin or liposomal doxorubicin formulations c) Has experienced prior dose limiting toxicity on Pegylated Liposomal Doxorubicin at 50 mg/m2 d) Prior doxorubicin exposure that would result in a total lifetime exposure of 550 mg/m2 or more after four cycles of treatment e) Is pregnant or breast feeding women f) Is unwilling or unable to provide adequate informed consent g) Has received prior standard chemotherapy or investigational agent within the past 28 days (6 weeks for mitomycin C and nitrosureas) prior to the start of first dosing for the study. h) Has undergone prior radiation therapy within the past 14 days prior to the start of first dosing of the study. i) Has undergone a major surgical procedure within 28 days of the start of first dosing of the study. Minor procedures such as biopsies or port placements are allowed as long as the patient has recovered j) Has an active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, P. carinii, or other microorganism that is under treatment with myelotoxic drugs k) Has clinically significant liver or kidney disease l) Has impaired cardiac function including any of the following conditions within past 6 months: • Unstable angina • QTc prolongation or other significant ECG abnormalities • Coronary artery bypass graft surgery • Symptomatic peripheral vascular disease • Myocardial infarction • NYHA class IIâ??IV heart failure • Severe uncontrolled ventricular arrhythmias • Clinically significant pericardial disease • Electrocardiographic evidence of acute ischemic or active conduction system abnormalities • Patients with evidence of abnormal cardiac conduction (e.g., bundle branch block or heart • block) • Severe uncontrolled arrhythmias m) Has history of consumption of excessive amounts of alcohol (greater than two drinks per day) or use drugs of abuse (including, but not limited to, cannabinoids and cocaine) as judged by their medical history will be excluded from study participation. n) Has history or presence of significant smoking (more than 10 cigarettes or equivalent tobacco products/day). o) Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg, Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg and Pulse rate less than 50 beats/minute or more than 100 beats/minute p) Any patients who have donated /or had loss of blood (1 unit or 350ml) within 90 days prior to receiving the first dose for the current study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-t and AUC0-â??Timepoint: 3.5 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To summarize the treatment emergent adverse events in patientsTimepoint: Throughout the study | — |
Countries
India
Contacts
Public ContactDr Sharath Sekar Shivamogga
Lotus Labs Pvt. Ltd
Outcome results
None listed