Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Maintenance Versus Observation After 6 Cycles of Gemcitabine Plus Paclitaxel in Pts With Advanced Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Samsung Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Korean Cancer Study Group
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00561119
First received: November 18, 2007
Last updated: November 8, 2010
Last verified: November 2010
  Purpose

The primary goal of therapy in patients with metastatic breast cancer is palliation and prolongation of life with quality. Although there are no randomized trials comparing chemotherapy with supportive care in women with metastatic breast cancer, chemotherapy clearly provides a survival benefit in metastatic breast cancer. Due to diagnosis at earlier phases of metastatic disease and more effective therapies, the median survival of patients treated with modern taxane-based chemotherapy is now reaching approximately 2 years. The duration of chemotherapy in patients responding or stable disease remains controversial, since quality of life is not usually adversely affected and may even be improved in many patients receiving cytotoxic chemotherapy. In addition, many commonly used chemotherapeutic agents are not limited by cumulative toxicity in metastatic breast cancer patients. Several studies investigated the role of maintenance chemotherapy suggest that maintenance chemotherapy is associated with superior time to progression but no survival gain. However, these randomized trials did not incorporate taxane-based chemotherapeutic regimens, the new standard of care in metastatic breast cancer patients these days. A 1998 metaanalysis of 1,986 patients randomly assigned between combination chemotherapy and single-agent therapy in metastatic breast cancer patients demonstrated a survival advantage to combination chemotherapy, with a hazard ratio of 0.82 (range, 0.75 to 0.90). Although there are several randomized trials showing negative results for survival gain in patients who received maintenance chemotherapy, the role of maintenance chemotherapy with newer agents, such as docetaxel or paclitaxel, have not been established yet. Although Italian MANTA trial demonstrated no difference in PFS or survival between the two arms, their metaanalysis advocated survival benefit of maintenance therapy. Since gemcitabine/paclitaxel (GP) combination chemotherapy is one of the two regimens which showed definite survival gain with favorable toxicity from a randomized trial, we plan to randomize patients who responded to six cycles of GP induction chemotherapy to receive additional maintenance GP chemotherapy until disease progression versus observation. We hypothesize that patients who receive maintenance GP chemotherapy will do better in terms of progression free survival.


Condition Intervention Phase
Advanced Breast Cancer
Drug: gemcitabine , paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III, Multicenter, Randomized Trial of Maintenance Versus Observation After Achieving Clinical Response in Pts With Metastatic or Recurrent Breast Cancer Who Received 6 Cycles of Gemcitabine Plus Paclitaxel(GP) as 1st-line Chemotherapy

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: approximately 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • a) overall survival b) quality of life c) toxicity of GP chemotherapy d) duration of response [ Time Frame: approximately 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 326
Study Start Date: May 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm 1
Observation after 6 cycles of gemcitabine plus paclitaxel till progression
Drug: gemcitabine , paclitaxel

Gemcitabine 1250 mg/m2 i.v. Day 1 & 8

Paclitaxel 175 mg/m2 i.v. day 1

repeat every 3 weeks

Experimental: Arm 2
Maintenance chemotherapy with gemcitabine plus paclitaxel after 6 cycles of gemcitabine plus paclitaxel till progression
Drug: gemcitabine , paclitaxel

Gemcitabine 1250 mg/m2 i.v. Day 1 & 8

Paclitaxel 175 mg/m2 i.v. day 1

repeat every 3 weeks


  Show Detailed Description

  Eligibility

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

Inclusion Criteria

  • Histologically Confirmed Metastatic, or Recurrent Breast Cancer
  • Age over 18 Years
  • ECOG Performance Status 0-2
  • Premenopausal or Postmenopausal Breast Cancer Patients With Measurable or Non-Measurable Lesions, Who Are Candidates for Chemotherapy
  • Life Expectancy ≥ 3 Months
  • Patients May Have Received Prior Neoadjuvant or Adjuvant Taxane Regimen as Long as it Has Been 12 Months Since Completion of Regimen.
  • Patients Either May or May Not Have a Prior Anthracycline Containing Regimen.
  • Prior Hormonal Therapy as a Treatment of Metastatic Disease is Allowed. But Antitumoral Hormonal Therapy Must be Terminated Prior to Enrollment(up to the Date of Randomization)
  • Prior Radiation Therapy Allowed as Long as < 25% of the Bone Marrow Has Been Treated,and the Patients Must Have Recovered From the Acute Toxic Effects of the Treatment Prior to Study Enrollment.Prior Radiation to the Whole Pelvis is Not Allowed. Prior Radiotherapy Must be Completed 4 Weeks Before Study Entry.
  • Adequate Bone Marrow Function (≥ ANC 1,500/ul, ≥ Platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
  • Adequate Renal Function (≤ Serum Creatinine 1.5 mg/dl or CCr ≥ 50 ml/Min)
  • Adequate Liver Function (≤ Serum Bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 Upper Normal Limit)
  • No Prior History of Chemotherapy for Metastatic, Recurrent Breast Cancer
  • Written Informed consent.

Exclusion Criteria

  • Serious Uncontrolled Intercurrent Infections
  • Serious Intercurrent Medical or Psychiatric Illness, Including Active Cardiac Disease
  • Pregnancy or Breast Feeding
  • Second Primary Malignancy(Except Cancer of Cervix or Skin or Other Malignancy Treated at Least 5 Years Previously With no Evidence of Recurrence)
  • Documented Parenchymal or Leptomeningeal Brain Metastasis
  • Peripheral Neuropathy ≥ Grade 2
  • Prior Treatment With Gemcitabine Will Not be Allowed.
  • HER-2 Overexpressing Breast Cancer and Concomitant Trastuzumab Treatment is Not Allowed
  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: NCT00561119

Locations
Korea, Republic of
Hanlym University Hospital
Anyang, Kyeongki-Do, Korea, Republic of, 431-070
Bundang Seoul National University Hospital
Bundang, Kyeongki-Do, Korea, Republic of, 463-707
Ajou University University Hospital
Suwon, Kyungki-Do, Korea, Republic of
Yeungnam University Hospital
Kyungsan, Kyungsangbuk-Do, Korea, Republic of
Daegu Patima Hospital
Daegu, Korea, Republic of, 701-600
Inha University School of Medicine
Inchon, Korea, Republic of, 400-711
Yonsei University Hospital
Seoul, Korea, Republic of, 120-752
Asan Medical Center
Seoul, Korea, Republic of
Ewha University Hospital
Seoul, Korea, Republic of, 911-1
National Cancer Center
Seoul, Korea, Republic of, 140-320
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Soonchunhyang University Hospital
Seoul, Korea, Republic of
Kunkuk University Hospital
Seoul, Korea, Republic of, 143-729
Ulsan University Hospital
Ulsan, Korea, Republic of, 682-714
Sponsors and Collaborators
Samsung Medical Center
Korean Cancer Study Group
Investigators
Principal Investigator: Young-Hyuck Im, M.D., Ph.D Samsung Medical Center
  More Information

No publications provided by Samsung Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Young-Hyuck Im, Chair of Breast Cancer subcommitte, KCSG, Korea Cancer Study Group
ClinicalTrials.gov Identifier: NCT00561119     History of Changes
Other Study ID Numbers: 2007-03-003
Study First Received: November 18, 2007
Last Updated: November 8, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
maintenance chemotherapy
metastatic or recurrent breast cancer
gemcitabine
paclitaxel(GP)

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Gemcitabine
Paclitaxel
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014