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

NCT00727961 | Completed Phase 4 Results

• 1 other identifier: P04072
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Complete Response

  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.

  4 weeks after chemotherapy completed

• Number of Participants With Partial Response

  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.

  4 weeks after chemotherapy completed

• Number of Participants With Stabilization

  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.

  4 weeks after chemotherapy completed

• Number of Participants With Progression

  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.

  4 weeks after chemotherapy completed

Secondary Outcomes (3)

• Mean Time to Positive (Partial) Treatment Response Achievement

  from the beginning of study drug administration up to 4 weeks after chemotherapy completed

• Median Time to Progression

  from the beginning of study drug administration up to 4 weeks after chemotherapy completed

• Mean Survival Time During the Study

  from the beginning of study drug administration up to 18 months

Study Arms (1)

Arm 1

EXPERIMENTAL

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

Drug: Pegylated Liposomal Doxorubicin hydrochloride

Interventions

Pegylated Liposomal Doxorubicin hydrochloride DRUG

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

Also known as: Caelyx

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

liposomal doxorubicin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck, Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: August 5, 2008
• Study Start: November 9, 2004
• Primary Completion: January 10, 2008
• Study Completion: January 10, 2008
• Last Updated: June 8, 2017
• Results First Posted: July 16, 2009

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share