Clinical trial NCT00191243: Docetaxel vs. Docetaxel-Gemcitabine in Breast Cancer
Official title: A Randomized Phase II Study Comparing Single-Agent Docetaxel to Alternating Docetaxel-Gemcitabine as Primary Chemotherapy in Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 237
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized,non-blinded,multi-center study in patients with metastatic breast cancer.Patients will be treated with docetaxel or docetaxel-gemcitabine.

Aim of the study is to assess the optimal dosage and safety in this setting.


Eligibility criteria: Inclusion Criteria:

* histologically verified diagnosis of breast carcinoma, at first diagnosis
* restricted previous adjuvant chemotherapy (completed \>6 months prior the study)
* measurable and/or non-measurable disease
* previous radiotherapy is allowed if:terminated at least 10 days prior the sudy therapy, at least one target lesion for evaluation of tumor response has not been irradiated
* performance status 0-2 (WHO, Zubrod)
* adequate bone marrow reserve defined
* adequate liver / renal functions defined

Exclusion Criteria:

* any prior systematic chemotherapy for metastatic breast cancer
* expected survival time less than 12 weeks
* past or current history of malignant neoplasm other than breast carcinoma

  * except for cured non-melanoma skin cancer or curatively treated in situ carcinoma of the cervix uteri
* known brain metastases/leptomeningeal involvement
* active uncontrolled infection
* symptomatic peripheral neuropathy \> grade 2 according to NCI
* patients whose lesions are assessable only by radionuclide scan or patients with sclerotic bone lesions as the only site of disease
* concomitant illness that is contraindication to the use of corticosteroids
* other concomitant serious illness or medical condition, which may worsen due to the treatment

Primary outcomes:
measure: Time to treatment failure (TTTF)
timeFrame: baseline to stopping treatment
Secondary outcomes:
measure: Response rate
timeFrame: baseline to measured progressive disease
measure: Duration of response
timeFrame: time of response to progressive disease
measure: Overall survival
timeFrame: baseline to date of death from any cause
measure: Time to progressive disease
timeFrame: baseline to measured progressive disease
Other outcomes:
Locations:
city: Hameenlinna
country: Finland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CT-LILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Helsinki
country: Finland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CT-LILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Jyvaskyla
country: Finland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CT-LILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Lappeenranta
country: Finland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CT-LILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Oulu
country: Finland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CT-LILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Pikonlinna
country: Finland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CT-LILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Pori
country: Finland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CT-LILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Turku
country: Finland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CT-LILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Joensuu H, Sailas L, Alanko T, Sunela K, Huuhtanen R, Utriainen M, Kokko R, Bono P, Wigren T, Pyrhonen S, Turpeenniemi-Hujanen T, Asola R, Leinonen M, Hahka-Kemppinen M, Kellokumpu-Lehtinen P. Docetaxel versus docetaxel alternating with gemcitabine as treatments of advanced breast cancer: final analysis of a randomised trial. Ann Oncol. 2010 May;21(5):968-73. doi: 10.1093/annonc/mdp397. Epub 2009 Oct 9.