Docetaxel vs. Docetaxel-Gemcitabine in Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Randomized Phase II Study Comparing Single-Agent Docetaxel to Alternating Docetaxel-Gemcitabine as Primary Chemotherapy in Patients With Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00191243
• Other study ID #: 5758
• Secondary ID: B9E-MC-S241
• Status: Completed
• Phase: Phase 2
• Start date: March 2002
• Est. completion date: April 2009

Study information

• Verified date: September 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: April 2009
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Gemcitabine
A: second line therapy - 1000 mg/m2, IV, day 1 and day 8 q 21 days until disease progression B: 1000 mg/m2, IV, day 1 and day 8 q 21 days, until treatment failure
• docetaxel
A: 80 mg/m2, IV, q 21 days until treatment failure followed by second line single agent gemcitabine B: 80 mg/m2, IV, q 21 days until treatment failure

Locations

Country	Name	City	State
Finland	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.	Hameenlinna
Finland	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.	Helsinki
Finland	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.	Jyvaskyla
Finland	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.	Lappeenranta
Finland	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.	Oulu
Finland	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.	Pikonlinna
Finland	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.	Pori
Finland	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.	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Joensuu H, Sailas L, Alanko T, Sunela K, Huuhtanen R, Utriainen M, Kokko R, Bono P, Wigren T, Pyrhönen S, Turpeenniemi-Hujanen T, Asola R, Leinonen M, Hahka-Kemppinen M, Kellokumpu-Lehtinen P. Docetaxel versus docetaxel alternating with gemcitabine as tre — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to treatment failure (TTTF)		baseline to stopping treatment
Secondary	Response rate		baseline to measured progressive disease
Secondary	Duration of response		time of response to progressive disease
Secondary	Overall survival		baseline to date of death from any cause
Secondary	Time to progressive disease		baseline to measured progressive disease

External Links

•   Lilly Clinical Trial Registry