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

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

This study has been completed.
Sponsor:
Information provided by:
Central European Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00294385
First received: February 20, 2006
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Docetaxel
Drug: Gemcitabine, Docetaxel
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: 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

Resource links provided by NLM:


Further study details as provided by Central European Cooperative Oncology Group:

Primary Outcome Measures:
  • 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:
  • Overall response rate
  • Response duration
  • Overall survival
  • 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

Enrollment: 430
Study Start Date: June 2002
Study Completion Date: October 2005
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00294385

Locations
Austria
2. Med. Abteilung - LKH-Steyr
Steyr, Austria, 4400
Hanusch KrankenhausHämatologisch-Onkologisches Zentrum
Vienna, Austria, 1140
Intere IV Krankenhaus Wels
Wels, Austria, 4600
Bulgaria
Cancer Center Plovdiv
Plovdiv, Bulgaria, 4000
SBALO National Oncology Center
Sofia, Bulgaria, 1527
SBALO National Oncology Center
Sofia, Bulgaria, 1756
Czech Republic
FN U sv. Anny
Brno, Czech Republic, 656 91
Nemocnice Ceske Budejovice
Ceske, Czech Republic
FN Hradec Kralove
Hradec Kralove, Czech Republic, 500 02
Charles University Prague, Dep of Oncology
Prague, Czech Republic
FN Bulovka
Prague, Czech Republic, 186 00
Israel
Rambam Medical Center, Oncol. Dep
Haifa, Israel, 31096
Tel Aviv Sourasky Medical Center, Div of Oncology
Tel Aviv, Israel
"Sheba" Medical Center, Dep of Oncology
Tel Hashomer, Israel
Lebanon
American University of Beirut, Medical Center
Beirut, Lebanon
Rizk Hospital
Beirut, Lebanon
Poland
Klinika Onkologii CMuJ
Krakow, Poland
Slovakia
Nomocnica Sv. Alzbety, Narodny Onkologicky Ustav
Bratislava, Slovakia
Sponsors and Collaborators
Central European Cooperative Oncology Group
Investigators
Principal Investigator: Christoph Wiltschke, Prof Univ. Klinik f. Innere Medizin I
  More Information

No publications provided

Responsible Party: Prof. Dr. Thomas Brodowicz, CECOG
ClinicalTrials.gov Identifier: NCT00294385     History of Changes
Other Study ID Numbers: CECOG/BC 1.3.002
Study First Received: February 20, 2006
Last Updated: June 22, 2011
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Central European Cooperative Oncology Group:
Breast Cancer
Docetaxel

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Docetaxel
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
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 27, 2014