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Docetaxel vs. Docetaxel-Gemcitabine in Breast Cancer
This study has been completed.
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00191243
  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 II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Docetaxel Gemcitabine hydrochloride Gemcitabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized Phase II Study Comparing Single-Agent Docetaxel to Alternating Docetaxel-Gemcitabine as Primary Chemotherapy in Patients With Metastatic Breast Cancer

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Time to treatment failure (TTTF) [ Time Frame: baseline to stopping treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
  • Time to progressive disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: March 2002
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental 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

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
B: Experimental 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

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
Genders 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
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.
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.
Turku, 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.
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.
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.
Pori, 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

Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

Responsible Party: Eli Lilly ( Chief Medical Officer )
Study ID Numbers: 5758, B9E-MC-S241
Study First Received: September 12, 2005
Last Updated: March 26, 2008
ClinicalTrials.gov Identifier: NCT00191243  
Health Authority: Finland: National Agency for Medicines

Study placed in the following topic categories:
Docetaxel
Skin Diseases
Breast Neoplasms
Gemcitabine
Breast Diseases

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
 Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009



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