Docetaxel vs. Docetaxel-Gemcitabine in Breast Cancer
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191243
First received: September 12, 2005
Last updated: March 26, 2008
Last verified: March 2008
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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 Endpoint Classification: Safety/Efficacy Study 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 ] [ 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 |
|---|---|
| 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:
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:
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. | |
| 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:
No publications provided
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00191243 History of Changes |
| Other Study ID Numbers: | 5758, B9E-MC-S241 |
| Study First Received: | September 12, 2005 |
| Last Updated: | March 26, 2008 |
| Health Authority: | Finland: Finnish Medicines Agency |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Gemcitabine Docetaxel Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 19, 2013