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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00294385
• Other study ID #: CECOG/BC 1.3.002
• Status: Completed
• Phase: Phase 3
• First received: February 20, 2006
• Last updated: June 22, 2011
• Start date: June 2002
• Est. completion date: October 2005

Study information

• Verified date: June 2011
• Source: Central European Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Docetaxel

• 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.
• 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.

Locations

Country	Name	City	State
Austria	2. Med. Abteilung - LKH-Steyr	Steyr
Austria	Hanusch KrankenhausHämatologisch-Onkologisches Zentrum	Vienna
Austria	Intere IV Krankenhaus Wels	Wels
Bulgaria	Cancer Center Plovdiv	Plovdiv
Bulgaria	SBALO National Oncology Center	Sofia
Bulgaria	SBALO National Oncology Center	Sofia
Czech Republic	FN U sv. Anny	Brno
Czech Republic	Nemocnice Ceske Budejovice	Ceske
Czech Republic	FN Hradec Kralove	Hradec Kralove
Czech Republic	Charles University Prague, Dep of Oncology	Prague
Czech Republic	FN Bulovka	Prague
Israel	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 Hashomer
Lebanon	American University of Beirut, Medical Center	Beirut
Lebanon	Rizk Hospital	Beirut
Poland	Klinika Onkologii CMuJ	Krakow
Slovakia	Nomocnica Sv. Alzbety, Narodny Onkologicky Ustav	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
Central European Cooperative Oncology Group

Countries where clinical trial is conducted

Austria,  Bulgaria,  Czech Republic,  Israel,  Lebanon,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall response rate
Secondary	Response duration
Secondary	Overall survival
Secondary	Characterize changes in performance status, patient-reported pain, and disease-related symptoms in each arm
Secondary	Characterize the nature of the toxicities experienced in each arm