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

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00727961

Purpose

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.

Condition	Intervention	Phase
Ovarian Neoplasms	Drug: Pegylated Liposomal Doxorubicin hydrochloride	Phase IV

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Obligatory Post-Registration Open-Label, Non-Comparative Multicenter Study of Efficacy and Tolerance Rate of Caelyx as Monotherapy in Patients With Epithelial Ovarian Cancer, Resistant to Previous Platinum Therapy.

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Evaluation of efficacy of Caelyx, namely, the rate of objective response, stabilization and progression [ Time Frame: Chest X-ray, CT, MRI will be performed every 2 cycles, last day of last cycle, and 4 weeks after chemotherapy is completed. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to response [ Time Frame: 28 days after the last cycle ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: 28 days after the last cycle ] [ Designated as safety issue: No ]
Time to disease progression [ Time Frame: 28 days after the last cycle ] [ Designated as safety issue: No ]
Number of patients withdrawn from the treatment due to intolerance [ Time Frame: 28 days after the last cycle ] [ Designated as safety issue: No ]
Survival [ Time Frame: 28 days after the last cycle ] [ Designated as safety issue: No ]

Enrollment:	58
Study Start Date:	November 2004
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental Caelyx IV, 50 mg/m^2, given for 6 cycles	Drug: Pegylated Liposomal Doxorubicin hydrochloride Caelyx IV, 50 mg/m^2 (60 minute infusion) on day 1, every 4 weeks, during 6 cycles

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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 18-65 year 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.

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04072
Study First Received:	June 23, 2008
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00727961
Health Authority:	Russia: Ethics Committee; Russia: Ministry of Health and Social Development of the Russian Federation

Study placed in the following topic categories:

Genital Diseases, Female
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases

Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Ovarian epithelial cancer
Doxorubicin
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses

Antibiotics, Antineoplastic
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 14, 2009