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

NCT ID: NCT00294385

Last Updated: 2011-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 430 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30
• Study Completion Date: 2005-10-31

Brief Summary

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Docetaxel

Intervention Type: DRUG

Gemcitabine, Docetaxel

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Docetaxel

Intervention Type: DRUG

Docetaxel

Intervention Type: DRUG

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.

Interventions

Docetaxel

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Central European Cooperative Oncology Group

OTHER

Sponsor Role: lead

Responsible Party

CECOG

Principal Investigators

Christoph Wiltschke, Prof

Role: PRINCIPAL_INVESTIGATOR

Univ. Klinik f. Innere Medizin I

Locations

2. Med. Abteilung - LKH-Steyr

Steyr, , Austria

Hanusch KrankenhausHämatologisch-Onkologisches Zentrum

Vienna, , Austria

Intere IV Krankenhaus Wels

Wels, , Austria

Cancer Center Plovdiv

Plovdiv, , Bulgaria

SBALO National Oncology Center

Sofia, , Bulgaria

SBALO National Oncology Center

Sofia, , Bulgaria

FN U sv. Anny

Brno, , Czechia

Nemocnice Ceske Budejovice

Ceske, , Czechia

FN Hradec Kralove

Hradec Králové, , Czechia

FN Bulovka

Prague, , Czechia

Charles University Prague, Dep of Oncology

Prague, , Czechia

Rambam Medical Center, Oncol. Dep

Haifa, , Israel

Tel Aviv Sourasky Medical Center, Div of Oncology

Tel Aviv, , Israel

"Sheba" Medical Center, Dep of Oncology

Tel Litwinsky, , Israel

American University of Beirut, Medical Center

Beirut, , Lebanon

Rizk Hospital

Beirut, , Lebanon

Klinika Onkologii CMuJ

Krakow, , Poland

Nomocnica Sv. Alzbety, Narodny Onkologicky Ustav

Bratislava, , Slovakia

Countries

Austria; Bulgaria; Czechia; Israel; Lebanon; Poland; Slovakia

Other Identifiers

CECOG/BC 1.3.002

Identifier Type: -

Identifier Source: org_study_id