Study Comparing Concomitant Docetaxel + Gemcitabine to Sequential Therapy of Docetaxel Followed by Gemcitabine

June 22, 2011 updated by: Central European Cooperative Oncology Group

A Randomized Phase III Study Comparing Concomitant Docetaxel Plus Gemcitabine to Sequential Therapy of Docetaxel Followed by Gemcitabine in Anthracycline-Pretreated Metastatic or Locally Recurrent Breast Cancer Patients

The purpose of this study is to compare the Time To Disease Progression (TTDP) between those patients with unresectable, locally recurrent or metastatic breast cancer who are treated with concomitant Docetaxel plus Gemcitabine to those patients treated with sequential therapy of Docetaxel followed by Gemcitabine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open, multicenter, two-armed Phase III study

Patients will be randomized to either of the following two arms:

Arm A (concomitant arm), Gemcitabine 1000 mglm2 will be administered intravenously on Days 1 and 8, repeated on Day 22. Docetaxel 75 mg/m2 will be given on Day 8 (before Gemcitabine), repeated on Day 22. This 3-week schedule defines a cycle of treatment for this arm. Overall 8 cycles will be administered.

Arm B (sequential arm) four cycles of Docetaxel 100 mg/m2 an Day 1, repeated an Day 22, followed by four cycles of Gemcitabine 1250 mg/m2 an a Day 1 and 8, repeated an Day 22, will be given. Both drugs will be administered in a 3-week schedule.

Bimonthly follow-up for patients without confirmed disease progression until progression of disease. Long-term follow-up for patients with confirmed disease progression will be done in 4 intervals.

For therapy control frequent blood chemistry and hematology, physical examination, weight control, potential adverse events and imaging procedures (CT, X-ray, MRI, Bone scan) am foreseen.

Study Type

Interventional

Enrollment (Actual)

430

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Steyr, Austria, 4400
        • 2. Med. Abteilung - LKH-Steyr
      • Vienna, Austria, 1140
        • Hanusch KrankenhausHämatologisch-Onkologisches Zentrum
      • Wels, Austria, 4600
        • Intere IV Krankenhaus Wels
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Cancer Center Plovdiv
      • Sofia, Bulgaria, 1527
        • SBALO National Oncology Center
      • Sofia, Bulgaria, 1756
        • SBALO National Oncology Center
  • Czech Republic
      • Brno, Czech Republic, 656 91
        • FN u Sv. Anny
      • Ceske, Czech Republic
        • Nemocnice Ceske Budejovice
      • Hradec Kralove, Czech Republic, 500 02
        • FN Hradec Králové
      • Prague, Czech Republic, 186 00
        • FN Bulovka
      • Prague, Czech Republic
        • Charles University Prague, Dep of Oncology
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center, Oncol. Dep
      • Tel Aviv, Israel
        • Tel Aviv Sourasky Medical Center, Div of Oncology
      • Tel Hashomer, Israel
        • "Sheba" Medical Center, Dep of Oncology
  • Lebanon
      • Beirut, Lebanon
        • American University of Beirut, Medical Center
      • Beirut, Lebanon
        • Rizk Hospital
  • Poland
      • Krakow, Poland
        • Klinika Onkologii CMuJ
  • Slovakia
      • Bratislava, Slovakia
        • Nomocnica Sv. Alzbety, Narodny Onkologicky Ustav

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with histologic or cytologic diagnosis of breast cancer with evidence of unresectable, locally recurrent, or metastatic disease.
  • Females, 18 to 75 years of age
  • pre-treated with ONE anthracyclines containing chemotherapy either in neoadjuvant/adjuvant or 1st line metastatic setting will be enrolled into the study
  • Patients with clinically measurable lesions will be enrolled in this study. Measurability is determined according to RECIST criteria
  • Performance status of 70 or higher on the Karnofsky Performance Scale
  • Adequate bone marrow reserve
  • Adequate liver function
  • Adequate renal function
  • Informed consent form patient or guardian
  • Childbearing potential either terminated by surgery, radiation, or menopause, use of an approved contraceptive method

Exclusion Criteria:

  • Active infection (at the discretion of the investigator).
  • Known or suspected brain metastases requiring steroid or radiation treatment.
  • Pregnancy (recent negative urine pregnancy test for pre-menopausal patients mandatory)
  • Breast-feeding
  • Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
  • Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin).
  • Bone metastases, pleural effusion, or ascites as the only site of disease.
  • Bone marrow transplantation or autologous stern cell infusion following high-dose chemotherapy for adjuvant or metastatic disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gemcitabine, Docetaxel
Arm A (concomitant arm), Gemcitabine 1000 mglm2 will be administered intravenously on Days 1 and 8, repeated on Day 22. Docetaxel 75 mg/m2 will be given on Day 8 (before Gemcitabine), repeated on Day 22. This 3-week schedule defines a cycle of treatment for this arm. Overall 8 cycles will be administered.
Drug: Docetaxel
Drug: Gemcitabine, Docetaxel
Arm A (concomitant arm), Gemcitabine 1000 mglm2 will be administered intravenously on Days 1 and 8, repeated on Day 22. Docetaxel 75 mg/m2 will be given on Day 8 (before Gemcitabine), repeated on Day 22. This 3-week schedule defines a cycle of treatment for this arm. Overall 8 cycles will be administered.
Drug: Docetaxel
rm B (sequential arm) four cycles of Docetaxel 100 mg/m2 an Day 1, repeated an Day 22, followed by four cycles of Gemcitabine 1250 mg/m2 an a Day 1 and 8, repeated an Day 22, will be given. Both drugs will be administered in a 3-week schedule.
Active Comparator: Docetaxel
Arm B (sequential arm) four cycles of Docetaxel 100 mg/m2 an Day 1, repeated an Day 22, followed by four cycles of Gemcitabine 1250 mg/m2 an a Day 1 and 8, repeated an Day 22, will be given. Both drugs will be administered in a 3-week schedule.
Drug: Docetaxel
Drug: Docetaxel
rm B (sequential arm) four cycles of Docetaxel 100 mg/m2 an Day 1, repeated an Day 22, followed by four cycles of Gemcitabine 1250 mg/m2 an a Day 1 and 8, repeated an Day 22, will be given. Both drugs will be administered in a 3-week schedule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
to compare the Time To Disease Progression between those patients with unresectable, locally recurrent or metastatic breast cancer who are treated with concomitant Docetaxel plus Gemcitabine to those patients treated with sequential therapy of Doc

Secondary Outcome Measures

Outcome Measure
Overall survival
Overall response rate
Response duration
Characterize changes in performance status, patient-reported pain, and disease-related symptoms in each arm
Characterize the nature of the toxicities experienced in each arm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central European Cooperative Oncology Group

Investigators

  • Principal Investigator: Christoph Wiltschke, Prof, Univ. Klinik f. Innere Medizin I

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

February 20, 2006

First Submitted That Met QC Criteria

February 20, 2006

First Posted (Estimate)

February 22, 2006

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 22, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CECOG/BC 1.3.002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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