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

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 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Number of Participants With Complete Response [ Time Frame: 4 weeks after chemotherapy completed ] [ Designated as safety issue: No ]
Number of Participants With Partial Response [ Time Frame: 4 weeks after chemotherapy completed ] [ Designated as safety issue: No ]
Number of Participants With Stabilization [ Time Frame: 4 weeks after chemotherapy completed ] [ Designated as safety issue: No ]
Number of Participants With Progression [ Time Frame: 4 weeks after chemotherapy completed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean Time to Positive (Partial) Treatment Response Achievement [ Time Frame: from the beginning of study drug administration up to 4 weeks after chemotherapy completed ] [ Designated as safety issue: No ]
Median Time to Progression [ Time Frame: from the beginning of study drug administration up to 4 weeks after chemotherapy completed ] [ Designated as safety issue: No ]
Mean Survival Time During the Study [ Time Frame: from the beginning of study drug administration up to 18 months ] [ 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
Experimental: Arm 1 Caelyx Intravenous, 50 mg/m^2, given for 6 cycles	Drug: Pegylated Liposomal Doxorubicin hydrochloride Caelyx Intravenous, 50 mg/m^2 (60 minute infusion) on day 1, every 4 weeks, during 6 cycles Other Name: Caelyx

Eligibility

Ages Eligible for Study:	18 Years and older
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 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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00727961 History of Changes
Other Study ID Numbers:	P04072
Study First Received:	June 23, 2008
Results First Received:	January 29, 2009
Last Updated:	September 25, 2009
Health Authority:	Russia: Ethics Committee Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:

Neoplasms
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female

Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013