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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum tolerated dose and recommended phase II dose (Phase I)

Safety Issue:

Yes

Principal Investigator

Yong Man Kim, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center

Authority:

Unspecified

Study ID:

CDR0000639513

NCT ID:

NCT00886717

Start Date:

May 2008

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • stage IIIA ovarian epithelial cancer
  • stage IIIB ovarian epithelial cancer
  • stage IIIC ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • stage IIIA ovarian germ cell tumor
  • stage IIIB ovarian germ cell tumor
  • stage IIIC ovarian germ cell tumor
  • stage IV ovarian germ cell tumor
  • Ovarian Neoplasms

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