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

NCT00294385 | Completed Phase 3

• 1 other identifier: CECOG/BC 1.3.002
• Study Type: interventional
• Target: 430
• Locations: 7 countries
• Sites: 18

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Docetaxel

Outcome Measures

Primary Outcomes (1)

• 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 (5)

• 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

Study Arms (2)

Gemcitabine, Docetaxel

ACTIVE COMPARATOR

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

Docetaxel

ACTIVE COMPARATOR

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

Interventions

Docetaxel DRUG

Docetaxel; Gemcitabine, Docetaxel

Gemcitabine, Docetaxel 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.

Gemcitabine, Docetaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central European Cooperative Oncology Group: lead

Study Sites (18)

2. Med. Abteilung - LKH-Steyr

Steyr, 4400, Austria

Location

Hanusch KrankenhausHämatologisch-Onkologisches Zentrum

Vienna, 1140, Austria

Location

Intere IV Krankenhaus Wels

Wels, 4600, Austria

Location

Cancer Center Plovdiv

Plovdiv, 4000, Bulgaria

Location

SBALO National Oncology Center

Sofia, 1527, Bulgaria

Location

SBALO National Oncology Center

Sofia, 1756, Bulgaria

Location

FN U sv. Anny

Brno, 656 91, Czechia

Location

Nemocnice Ceske Budejovice

Ceske, Czechia

Location

FN Hradec Kralove

Hradec Králové, 500 02, Czechia

Location

FN Bulovka

Prague, 186 00, Czechia

Location

Charles University Prague, Dep of Oncology

Prague, Czechia

Location

Rambam Medical Center, Oncol. Dep

Haifa, 31096, Israel

Location

Tel Aviv Sourasky Medical Center, Div of Oncology

Tel Aviv, Israel

Location

"Sheba" Medical Center, Dep of Oncology

Tel Litwinsky, Israel

Location

American University of Beirut, Medical Center

Beirut, Lebanon

Location

Rizk Hospital

Beirut, Lebanon

Location

Klinika Onkologii CMuJ

Krakow, Poland

Location

Nomocnica Sv. Alzbety, Narodny Onkologicky Ustav

Bratislava, Slovakia

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Christoph Wiltschke, Prof

  Univ. Klinik f. Innere Medizin I

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 20, 2006
• First Posted: February 22, 2006
• Study Start: June 1, 2002
• Study Completion: October 1, 2005
• Last Updated: June 23, 2011

Record last verified: 2011-06

Locations

IL (3); PL (1); AU (3); SL (1); LE (2); CZ (5); BU (3)