Clinical trial NCT00294385: Study Comparing Concomitant Docetaxel + Gemcitabine to Sequential Therapy of Docetaxel Followed by Gemcitabine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast Cancer
Docetaxel
Lead sponsor: Central European Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2006-02-22
Enrollment: 430
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
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 outcomes:
measure: Overall response rate
measure: Response duration
measure: Overall survival
measure: Characterize changes in performance status, patient-reported pain, and disease-related symptoms in each arm
measure: Characterize the nature of the toxicities experienced in each arm
Other outcomes:
Locations:
city: Steyr
country: Austria
facility: 2. Med. Abteilung - LKH-Steyr
city: Vienna
country: Austria
facility: Hanusch KrankenhausHämatologisch-Onkologisches Zentrum
city: Wels
country: Austria
facility: Intere IV Krankenhaus Wels
city: Plovdiv
country: Bulgaria
facility: Cancer Center Plovdiv
city: Sofia
country: Bulgaria
facility: SBALO National Oncology Center
city: Sofia
country: Bulgaria
facility: SBALO National Oncology Center
city: Brno
country: Czech Republic
facility: FN U sv. Anny
city: Ceske
country: Czech Republic
facility: Nemocnice Ceske Budejovice
city: Hradec Kralove
country: Czech Republic
facility: FN Hradec Kralove
city: Prague
country: Czech Republic
facility: FN Bulovka
city: Prague
country: Czech Republic
facility: Charles University Prague, Dep of Oncology
city: Haifa
country: Israel
facility: Rambam Medical Center, Oncol. Dep
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center, Div of Oncology
city: Tel Hashomer
country: Israel
facility: "Sheba" Medical Center, Dep of Oncology
city: Beirut
country: Lebanon
facility: American University of Beirut, Medical Center
city: Beirut
country: Lebanon
facility: Rizk Hospital
city: Krakow
country: Poland
facility: Klinika Onkologii CMuJ
city: Bratislava
country: Slovakia
facility: Nomocnica Sv. Alzbety, Narodny Onkologicky Ustav
Study officials:
affiliation: Univ. Klinik f. Innere Medizin I
name: Christoph Wiltschke, Prof
role: PRINCIPAL_INVESTIGATOR
References: