A Study to Evaluate Efficacy and Tolerance of Caelyx in Patients With Epithelial Ovarian Cancer. (Study P04072)(COMPLETED)

NCT ID: NCT00727961

Last Updated: 2017-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-09
• Study Completion Date: 2008-01-10

Brief Summary

The aim of this study is to evaluate efficacy and tolerability, and number of positive response to treatment with CAELYX (50 mg/m^2), administered as monotherapy once per 4 weeks to patients with metastatic epithelial ovarian cancer, resistant to previous platinum therapy.

Conditions

Ovarian Neoplasms

Study Design

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

Study Groups

Arm 1

Caelyx Intravenous, 50 mg/m\^2, given for 6 cycles

Group Type: EXPERIMENTAL

Pegylated Liposomal Doxorubicin hydrochloride

Intervention Type: DRUG

Caelyx Intravenous, 50 mg/m\^2 (60 minute infusion) on day 1, every 4 weeks, during 6 cycles

Interventions

Pegylated Liposomal Doxorubicin hydrochloride

Caelyx Intravenous, 50 mg/m\^2 (60 minute infusion) on day 1, every 4 weeks, during 6 cycles

Intervention Type: DRUG

Other Intervention Names

Caelyx

Eligibility Criteria

Inclusion Criteria

• Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent and/or parent or legal guardian must have signed a written informed consent.
• Women must be greater than or equal to 18 years of age, of any race.
• Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
• Morphology (cytology or histology) confirmed diagnosis of epithelial ovarian cancer.
• Patients with 1 or more measurable and/or evaluable tumors, according to the results of CT, MRT scans or X-ray, etc.
• Patients, including those after primary surgical treatment, who had previously received platinum chemotherapy and in whom second-line therapy is indicated.
• Karnofsky performance status above 60%.
• Left ventricular ejection fraction above 50% (according to the results of echocardiography).
• Adequate bone marrow function as indicated by:

• Platelets >100x10^9/L
• Haemoglobin > 9 g/dL
• Absolute neutrophil count >1.5x10^9/L
• Adequate renal function as indicated by:

• Serum creatinine < 1.5 х ULN
• Adequate liver function as indicated by:

• Bilirubin level and AST or ALT activity < 2 х ULN (with the exception of cases related to primary disease).

Exclusion Criteria

• Women who are pregnant or nursing.
• Subjects who have not observed the designated washout periods for any of the prohibited medications.
• Subjects who have used any investigational product within 30 days prior to enrollment.
• Medical history indicating serious concomitant diseases, such as congestive heart failure of II NYHA class or higher, insulin-dependent diabetes mellitus, clinically significant liver disease, mental disorders.
• Non-controlled bacterial, viral or fungal infections.
• Conditions and reasons (medical, social and psychological) that might prevent adequate follow-up of patients.
• Any other active primary tumor under treatment (except basal or squamous cell carcinoma or in situ cervix carcinoma).
• Patient has symptomatic metastasis to brain.

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

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P04072

Identifier Type: -

Identifier Source: org_study_id