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

Sponsor

Asan Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00886717

Collaborator

(none)

Enrollment

Locations

18.5

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer	Drug: carboplatin Drug: paclitaxel-loaded polymeric micelle	Phase 1/Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

74 participants

Allocation:

Non-Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

May 1, 2008

Outcome Measures

Primary Outcome Measures

Maximum tolerated dose and recommended phase II dose (Phase I) []
Efficacy, in terms of CA-125 response rate after 6 courses of therapy (Phase II) []

Secondary Outcome Measures

Preliminary antitumor activity, in terms of objective response rate (complete response and partial response), time to tumor progression, and progression-free survival (Phase I) []
Safety profiles (Phase I) []
Objective response rate as measured by RECIST criteria (Phase II) []
Overall survival (Phase II) []
Overall response (Phase II) []
Safety and toxicity (Phase II) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Seoul National University Hospital	Seoul	Korea, Republic of	110-744
2	Yonsei Cancer Center at Yonsei University Medical Center	Seoul	Korea, Republic of	120-752
3	Samsung Medical Center	Seoul	Korea, Republic of	135-710
4	Asan Medical Center - University of Ulsan College of Medicine	Seoul	Korea, Republic of	138-736