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

NCT01169870 | Withdrawn Phase 2

• 1 other identifier: NCCCTS-07-278
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Breast Cancer

Keywords

metastatic

Outcome Measures

Primary Outcomes (1)

• overall response rate

  21Aug2007~22Aug2008

Study Arms (2)

Genexol-PM

EXPERIMENTAL

Genexol-PM 300mg/m2, diluted with 500ml of 5% dextrose or normal saline, intravenous infusion over 1 hour on day 1, every 3 week cycle.

Drug: Genexol-PM

Paclitaxel

ACTIVE COMPARATOR

Paclitaxel 175mg/m2, diluted with 500ml of 5% dextrose or normal saline, intravenous infusion over 3 hour on day 1, every 3 week cycle.

Drug: Paclitaxel

Interventions

Genexol-PM DRUG

Treatment is given in the outpatient setting. Patients receive treatment every 3 weeks up to 6 cycles.

Genexol-PM

Paclitaxel DRUG

Paclitaxel

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically diagnosed stage IV or recurrent breast cancer patients according to American Joint Committee on Cancer (AJCC 6th ed.)
• Prior chemotherapy at least one anthracycline-containing regimen, in either adjuvant or metastatic setting is requested.
• Previous hormonal therapy in adjuvant setting is allowed.
• Previous adjuvant taxane chemotherapy in an adjuvant setting is allowed, if taxane-free interval is more than 12 months
• previous chemotherapy for metastatic disease is not allowed except for the regimen including anthracycline.
• Previous chemotherapy including taxane for metastatic disease is not allowed.
• Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
• No other forms of cancer therapy, such as radiation, immunotherapy or chemotherapy for at least 4 weeks before the enrollment in therapy.
• Major surgery other than biopsy within the past two weeks.
• At least 18 years old
• Performance status of 0, 1 and 2 on the ECOG criteria.
• Disease status must be that of measurable disease defined as RECIST:
• Lesions that can be accurately measured in at least one dimension \> 10 mm with chest x-ray, spiral CT scan, MRI, or physical examination
• Estimated life expectancy of at least 12 weeks.
• Patient compliance that allow adequate follow-up.

You may not qualify if:

• Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complication of study therapy
• Other malignancy with the past 5 years except adequately treated cutaneous basal cell carcinoma or uterine cervix in situ cancer
• Psychiatric disorder that would preclude compliance.
• uncontrolled CNS disease (eligible if the CNS disease is controlled with radiotherapy or corticosteroid)

Sponsors & Collaborators

• National Cancer Center, Korea: lead

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

genexol-PM; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Jungsil Ro, Ph,D

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Center for Clinical Trials, National Cancer Center, Korea

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: July 26, 2010
• Study Start: July 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: October 1, 2008
• Last Updated: January 4, 2012

Record last verified: 2012-01