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

This study has been withdrawn prior to enrollment.
(withdrawn studies)
Sponsor:
Information provided by (Responsible Party):
Jungsil Ro, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01169870
First received: February 8, 2010
Last updated: January 1, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Genexol-PM
Drug: Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of Genexol-PM vs Paclitaxel in Anthracycline-pretreated Metastatic Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • overall response rate [ Time Frame: 21Aug2007~22Aug2008 ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: July 2007
Study Completion Date: October 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Genexol-PM
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169870

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

No publications provided

Responsible Party: Jungsil Ro, Chief, Center for Clinical Trials, National Cancer Center, Korea, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01169870     History of Changes
Other Study ID Numbers: NCCCTS-07-278
Study First Received: February 8, 2010
Last Updated: January 1, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by National Cancer Center, Korea:
metastatic

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014