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Docetaxel vs. Docetaxel-Gemcitabine in Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191243
First received: September 12, 2005
Last updated: November 21, 2016
Last verified: November 2016
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Gemcitabine
Drug: docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study Comparing Single-Agent Docetaxel to Alternating Docetaxel-Gemcitabine as Primary Chemotherapy in Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Time to treatment failure (TTTF) [ Time Frame: baseline to stopping treatment ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: baseline to measured progressive disease ]
  • Duration of response [ Time Frame: time of response to progressive disease ]
  • Overall survival [ Time Frame: baseline to date of death from any cause ]
  • Time to progressive disease [ Time Frame: baseline to measured progressive disease ]

Enrollment: 237
Study Start Date: March 2002
Study Completion Date: April 2009
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 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

Other Names:
  • LY188011
  • Gemzar
Drug: 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

Experimental: B 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

Other Names:
  • LY188011
  • Gemzar
Drug: 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


  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191243

Locations
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, Finland
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

Additional Information:
Publications:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00191243     History of Changes
Other Study ID Numbers: 5758
B9E-MC-S241 ( Other Identifier: Eli Lilly and Company )
Study First Received: September 12, 2005
Last Updated: November 21, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Keywords provided by Eli Lilly and Company:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Gemcitabine
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 25, 2017