NCT01169870

Genexol-PM Versus Paclitaxel in Anthracycline-pretreated Metastatic Breast Cancer Patients

A Randomized Phase II Trial of Genexol-PM vs Paclitaxel in Anthracycline-pretreated Metastatic Breast Cancer Patients

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the overall response rate of Genexol-PM compared with paclitaxel (cremophor-based paclitaxel) as palliative chemotherapy in anthracycline-pretreated patients with metastatic breast cancer.

Detailed description

This is a prospective, two-armed, parallel group, randomized phase II study for the evaluation of Genexol-PM and paclitaxel. Up to 42 eligible patients will be enrolled in each treatment arm (a total of 84) according to the trial design. Patients will be randomly allocated to arm A (Genexol-PM) or arm B (Paclitaxel). They will be stratified by ER status(positive v negative), performance(ECOG 0 or 1 v 2), and prior adjuvant taxane (no v yes) The treatment will be continued up to 6 cycles, or will be discontinued before 6th cycle iin case of disease progression, unacceptable toxicity, or patient withdrawal. After discontinuation of study therapy, patients will proceed to the post-therapy follow-up phase of the study. Patients may be enrolled in the study if they have documented measurable disease. Response will be documented by physical examination prior to each treatment cycle and a CT scan every two cycles or if disease progression is suspected. Responses will be assessed unidimensionally according to the RECIST. All partial or complete responses require confirmation with a second evaluation at least 4 weeks following the first documentation of response. All toxicities encountered during the study will be evaluated before each cycle using the NCI CTC (National Cancer Institute Common Toxicity Criteria) version 3.0 scale. For peripheral neuropathy, the scale in Table 4 will be used to determine dose adjustments. Life-threatening toxicities should be reported immediately to the Study Chairman.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Genexol-PM	Treatment is given in the outpatient setting. Patients receive treatment every 3 weeks up to 6 cycles.
DRUG	Paclitaxel

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-08-01
• Completion: 2008-10-01
• First posted: 2010-07-26
• Last updated: 2012-01-04