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

Information source: Central European Cooperative Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Docetaxel (Drug); Gemcitabine, Docetaxel (Drug); Docetaxel (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Central European Cooperative Oncology Group

Official(s) and/or principal investigator(s):
Christoph Wiltschke, Prof, Principal Investigator, Affiliation: Univ. Klinik f. Innere Medizin I

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.

Clinical Details

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

Primary outcome: 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:

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

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Female.

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.

Locations and Contacts

2. Med. Abteilung - LKH-Steyr, Steyr 4400, Austria

Hanusch KrankenhausHämatologisch-Onkologisches Zentrum, Vienna 1140, Austria

Intere IV Krankenhaus Wels, Wels 4600, Austria

Cancer Center Plovdiv, Plovdiv 4000, Bulgaria

SBALO National Oncology Center, Sofia 1756, Bulgaria

SBALO National Oncology Center, Sofia 1527, Bulgaria

FN U sv. Anny, Brno 656 91, Czech Republic

Nemocnice Ceske Budejovice, Ceske, Czech Republic

FN Hradec Kralove, Hradec Kralove 500 02, Czech Republic

Charles University Prague, Dep of Oncology, Prague, Czech Republic

FN Bulovka, Prague 186 00, Czech Republic

Rambam Medical Center, Oncol. Dep, Haifa 31096, Israel

Tel Aviv Sourasky Medical Center, Div of Oncology, Tel Aviv, Israel

"Sheba" Medical Center, Dep of Oncology, Tel Hashomer, 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

Additional Information

Starting date: June 2002
Last updated: June 22, 2011

Page last updated: August 23, 2015

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