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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01169870
Recruitment Status : Withdrawn (withdrawn studies)
First Posted : July 26, 2010
Last Update Posted : January 4, 2012
Information provided by (Responsible Party):
Jungsil Ro, National Cancer Center, Korea

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Genexol-PM Drug: Paclitaxel Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of Genexol-PM vs Paclitaxel in Anthracycline-pretreated Metastatic Breast Cancer Patients
Study Start Date : July 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Genexol-PM
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
Treatment is given in the outpatient setting. Patients receive treatment every 3 weeks up to 6 cycles.
Active Comparator: Paclitaxel
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

Primary Outcome Measures :
  1. overall response rate [ Time Frame: 21Aug2007~22Aug2008 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically or cytologically diagnosed stage IV or recurrent breast cancer patients according to American Joint Committee on Cancer (AJCC 6th ed.)
  2. Prior chemotherapy at least one anthracycline-containing regimen, in either adjuvant or metastatic setting is requested.
  3. Previous hormonal therapy in adjuvant setting is allowed.
  4. Previous adjuvant taxane chemotherapy in an adjuvant setting is allowed, if taxane-free interval is more than 12 months
  5. previous chemotherapy for metastatic disease is not allowed except for the regimen including anthracycline.
  6. Previous chemotherapy including taxane for metastatic disease is not allowed.
  7. Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
  8. No other forms of cancer therapy, such as radiation, immunotherapy or chemotherapy for at least 4 weeks before the enrollment in therapy.
  9. Major surgery other than biopsy within the past two weeks.
  10. At least 18 years old
  11. Performance status of 0, 1 and 2 on the ECOG criteria.
  12. 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

  13. Estimated life expectancy of at least 12 weeks.
  14. Patient compliance that allow adequate follow-up.
  15. Adequate major organ function including the following:

    ①Hematologic function: WBC ³ 3,000/mm3 or absolute neutrophil count (ANC) ³ 1,500/mm3, platelet count ³ 100,000/mm3

    ②Hepatic function: bilirubin 1.5 x UNL , AST/ALT levels 2.5 x UNL

    ③Renal function: serum creatinine 1.5mg/dL

  16. Grade of baseline neuropathy should not be more than grade 1 by NCI CTC v.3.0
  17. Patients should sign an informed consent
  18. women of childbearing age should use non-hormonal contraceptive method.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01169870

Sponsors and Collaborators
National Cancer Center, Korea
Principal Investigator: Jungsil Ro, Ph,D National Cancer Center, Korea

Responsible Party: Jungsil Ro, Chief, Center for Clinical Trials, National Cancer Center, Korea, National Cancer Center, Korea Identifier: NCT01169870     History of Changes
Other Study ID Numbers: NCCCTS-07-278
First Posted: July 26, 2010    Key Record Dates
Last Update Posted: January 4, 2012
Last Verified: January 2012

Keywords provided by Jungsil Ro, National Cancer Center, Korea:

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action