A Phase III Trial For Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
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
  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:
  • LY188011
  • Gemzar
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
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: NCT00191152

  Show 65 Study Locations
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 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 by Site
Neoplasms
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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on September 16, 2014