A Phase III Trial For Patients With Metastatic Breast Cancer
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191152
First received: September 12, 2005
Last updated: December 21, 2009
Last verified: December 2009
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Purpose
This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/ capecitabine doublets, with crossover to the alternate agent. The experimental arm will receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75 mg/m2 IV day 1 over 1 hour repeated every three weeks. The comparator arm will receive docetaxel 75 mgm/m2 IV day 1 over 1 hour and oral capecitabine 1000 mg/m2 twice daily, days 1 through 14 repeated every three weeks. Patients who progress on the experimental arm, will be treated with capecitabine as dosed on the comparator arm. Patients who progress on the comparator arm will be treated with gemcitabine as dosed on the experimental arm.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Breast Neoplasms Cancer of the Breast |
Drug: gemcitabine Drug: docetaxel Drug: capecitabine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Trial of Gemcitabine Plus Docetaxel vs. Docetaxel Plus Capecitabine in Metastatic Breast Cancer in 1st and 2nd |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Time to Disease Progression (Initial Treatment) [ Time Frame: Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to Disease Progression (Crossover Treatment) [ Time Frame: Date of first dose of crossover treatment to date of first-documented disease progression after receiving first crossover treatment or date of death due to study disease, whichever came first (up to 82 months) ] [ Designated as safety issue: No ]
- Progression-Free Survival (Initial Treatment) [ Time Frame: Date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 82 months) ] [ Designated as safety issue: No ]
- Progression-Free Survival (Crossover Treatment) [ Time Frame: First dose date of crossover treatment to date of first-documented progression after receiving crossover treatment or date of death due to any cause, whichever came first (up to 82 months) ] [ Designated as safety issue: No ]
- Duration of Response (Initial Treatment) [ Time Frame: Date of response (CR or PR) until the first date of documented progression or death from any cause (up to 82 months) ] [ Designated as safety issue: No ]
- Duration of Response (Crossover Treatment) [ Time Frame: Date of CR or PR until first date of recurrent or progressive disease after receiving crossover treatment was objectively documented or date of date due to any cause, whichever came first (up to 82 months) ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: Date of randomization to date of death from any cause (up to 82 months) ] [ Designated as safety issue: No ]
- Best Overall Response (Initial Treatment) [ Time Frame: Best response from start of treatment until disease progression/recurrence (up to 82 months) ] [ Designated as safety issue: No ]
- Best Overall Response (Crossover Treatment) [ Time Frame: Best response from start of treatment until disease progression/recurrence (up to 82 months) ] [ Designated as safety issue: No ]
- Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Initial Treatment) [ Time Frame: Baseline until crossover treatment began (up to 82 months) ] [ Designated as safety issue: No ]
- Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Crossover Treatment) [ Time Frame: First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 moths) ] [ Designated as safety issue: No ]
- Summary of Changes in Rotterdam Symptom Checklist (RSCL) by Treatment (Initial Treatment) [ Time Frame: Baseline until crossover treatment began (up to 82 months) ] [ Designated as safety issue: No ]
- Summary of Changes in Rotterdam Symptom Checklist by Treatment (Crossover Treatment) [ Time Frame: First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 months) ] [ Designated as safety issue: No ]
| Enrollment: | 475 |
| Study Start Date: | February 2002 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Gemcitabine + Docetaxel |
Drug: gemcitabine
1000 mg/m2, intravenous (IV) day 1 and day 8 every 21 days until disease progression
Other Names:
Drug: docetaxel
75 mg/m2, intravenous (IV), every 21 days until disease progression
|
| Active Comparator: Capecitabine + Docetaxel |
Drug: docetaxel
75 mg/m2, intravenous (IV), every 21 days until disease progression
Drug: capecitabine
1000 mg/m2, by mouth (PO) twice a day (BID), days 1-14, every 21 days until disease progression
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologic or cytologic confirmation of breast cancer with locally advanced and/or metastatic disease
- Patients may have received prior neo-adjuvant or adjuvant taxane regimen as long as it has been greater than or equal to 6 months since completion of the regimen
- Patients may have had 0-1, but no more than one prior course of chemotherapy for metastatic disease
- Patients must have either measurable or non-measurable (evaluable) disease
- Prior radiation therapy allowed of less than 25% of the bone marrow
Exclusion Criteria:
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence)
- Parenchymal or leptomeningeal brain metastases
- Peripheral neuropathy greater than or equal to grade 2
- Prior treatment with gemcitabine and capecitabine will not be allowed. Prior treatment with a taxane in the metastatic setting will not be allowed. Prior taxane therapy in the neo-adjuvant or adjuvant setting is allowed if completion of therapy greater than or equal to 6 months prior to enrollment.
- Active cardiac disease not controlled by therapy and/or myocardial infarction within the preceding 6 months.
- Concomitant Herceptin is not allowed
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191152
Show 65 Study Locations
Show 65 Study LocationsSponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM 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: | NCT00191152 History of Changes |
| Other Study ID Numbers: | 4703, B9E-US-S188 |
| Study First Received: | September 12, 2005 |
| Results First Received: | November 4, 2009 |
| Last Updated: | December 21, 2009 |
| Health Authority: | United States: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Brazil: National Health Surveillance Agency South Korea: Korea Food and Drug Administration (KFDA) Taiwan: Department of Health Mexico: Federal Commission for Protection Against Health Risks |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Gemcitabine Capecitabine 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 22, 2013