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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00727961
First received: June 23, 2008
Last updated: April 28, 2014
Last verified: April 2014
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants With Complete Response [ Time Frame: 4 weeks after chemotherapy completed ] [ Designated as safety issue: No ]
    Complete response was defined as complete disappearance of all measurable and assessable disease with no new disease or disease-related symptoms as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.

  • Number of Participants With Partial Response [ Time Frame: 4 weeks after chemotherapy completed ] [ Designated as safety issue: No ]
    Required 50 percent or greater decrease in sum of products of all bidimensionally measurable lesions without progression of assessable disease and no new lesions as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.

  • Number of Participants With Stabilization [ Time Frame: 4 weeks after chemotherapy completed ] [ Designated as safety issue: No ]
    All other subjects (except complete or partial responders and those with progression [see prior definitions]) were classified as stable disease as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.

  • Number of Participants With Progression [ Time Frame: 4 weeks after chemotherapy completed ] [ Designated as safety issue: No ]
    Progressive disease was defined as 25% or greater increase in the size of measurable lesion. The reappearance of any lesion or clear worsening of assessable disease or the appearance of any new lesion was also considered as progressive disease as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.


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 ]

    Time to the occurence of partial effect achievement as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.

    Partial response required a 50 percent or greater decrease in the sum of the products of all bidimensionally measurable lesions without progression of any assessable disease and no new lesions.


  • 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 ]
    Median time to the occurence of progression. Progression was defined as 25 percent or greater increase size of measurable lesion. Reappearance of lesion, worsening of assessable disease or appearance new lesions were considered progression as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.

  • Mean Survival Time During the Study [ Time Frame: from the beginning of study drug administration up to 18 months ] [ Designated as safety issue: No ]
    Mean time to the occurrence of death


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
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: April 28, 2014
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 July 26, 2014