Paclitaxel-Loaded Polymeric Micelle and Carboplatin as First-Line Therapy in Treating Patients With Advanced Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

Open-label, Multicenter, Phase I/II Trial to Evaluate Efficacy Safety of the Combination Therapy of Genexol-PM and Carboplatin as a Firstline Treatment in Subjects With Advanced Ovarian Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00886717
• Other study ID #: AMC-UUCM-GPMOC201
• Secondary ID: CDR0000639513
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: April 22, 2009
• Last updated: August 1, 2013
• Start date: May 2008

Study information

• Verified date: December 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel-loaded polymeric micelle and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel-loaded polymeric micelle and carboplatin and to see how well they work as first-line therapy in treating patients with advanced ovarian cancer.

Description:

OBJECTIVES:

Primary

• Determine the maximum tolerated dose and recommended phase II dose of paclitaxel-loaded polymeric micelle and carboplatin as first-line therapy in patients with advanced ovarian cancer. (Phase I)

• Evaluate the efficacy of this regimen, in terms of CA-125 response rate after 6 courses of therapy. (Phase II)

Secondary

• Assess, preliminarily, the antitumor activity of this regimen, in terms of objective response rate (complete response and partial response), time to tumor progression, and progression-free survival, in these patients. (Phase I)

• Evaluate the safety profiles of this regimen in these patients. (Phase I)

• Determine the objective response rate, as measured by RECIST criteria, in patients treated with this regimen. (Phase II)

• Determine the overall survival of patients treated with this regimen. (Phase II)

• Determine the overall response in patients treated with this regimen. (Phase II)

• Evaluate the safety and toxicity of this regimen in these patients. (Phase II)

OUTLINE: This is a multicenter study.

Patients receive paclitaxel-loaded polymeric micelle and carboplatin.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed advanced ovarian cancer

• Measurable disease by RECIST criteria

• No prior or concurrent CNS metastasis

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy > 6 months

• Clinically acceptable blood, kidney, and spleen function

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No preexisting sensory or motor neuropathy = grade 1

• No other malignancies within the past 5 years

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy for ovarian cancer

• No prior immunotherapy or hormonal therapy for ovarian cancer

• No prior radiotherapy to the pelvis or abdominal cavity

• More than 2 weeks since prior major surgery other than debulking surgery

Study Design

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• carboplatin

• paclitaxel-loaded polymeric micelle

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center - University of Ulsan College of Medicine	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei Cancer Center at Yonsei University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose and recommended phase II dose (Phase I)			Yes
Primary	Efficacy, in terms of CA-125 response rate after 6 courses of therapy (Phase II)			No
Secondary	Preliminary antitumor activity, in terms of objective response rate (complete response and partial response), time to tumor progression, and progression-free survival (Phase I)			No
Secondary	Safety profiles (Phase I)			Yes
Secondary	Objective response rate as measured by RECIST criteria (Phase II)			No
Secondary	Overall survival (Phase II)			No
Secondary	Overall response (Phase II)			No
Secondary	Safety and toxicity (Phase II)			Yes