Phase III Study of Two Different Schedules (Weekly and Tri-weekly) of Combination of Gemcitabine and Two Taxanes in MBC

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00236899
First received: October 7, 2005
Last updated: August 22, 2011
Last verified: August 2011
  Purpose

Multi-center, randomized Phase III study. 4 arms. 360 Patient to enroll. Purpose is evaluate time to progression disease (PD).


Condition Intervention Phase
Metastatic Breast Cancer (MBC)
Drug: Gemcitabine
Drug: Docetaxel
Drug: Paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial of Gemcitabine and Docetaxel Versus Gemcitabine and Paclitaxel in Patients With Metastatic Breast Cancer: A Comparison of Different Schedules

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Time to Progressive Disease (TTPD) by Treatment Schedule [ Time Frame: Baseline up to 49.84 months ] [ Designated as safety issue: No ]
    TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions.

  • Time to Progressive Disease (TTPD) by Treatment Drug [ Time Frame: Baseline up to 49.84 months ] [ Designated as safety issue: No ]
    TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions.


Secondary Outcome Measures:
  • Overall Survival (OS) by Treatment Schedule [ Time Frame: Baseline up to 51.64 months ] [ Designated as safety issue: Yes ]
    OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit).

  • Overall Survival (OS) by Treatment Drug [ Time Frame: Baseline up to 51.64 months ] [ Designated as safety issue: Yes ]
    OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit).

  • Overall Response Rate (ORR) by Treatment Schedule [ Time Frame: Baseline up to 49.84 months ] [ Designated as safety issue: No ]
    Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response≥30% decrease in sum of longest diameter of target lesions; Progressive Disease≥20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Not Available=participants assessed whose data were not available. Not Assessed=participants who did not participate in assessments. The ORR=sum of complete and partial tumor responses observed, divided by the total number of evaluable participants.

  • Overall Response Rate(ORR) by Treatment Drug [ Time Frame: Baseline up to 49.84 months ] [ Designated as safety issue: Yes ]
    Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response≥30% decrease in sum of longest diameter of target lesions; Progressive Disease≥20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Not Available=participants assessed whose data were not available. Not Assessed=participants who did not participate in assessments. The ORR=sum of complete and partial tumor responses observed, divided by the total number of evaluable participants.

  • Number of Participants With Serious and Nonserious Adverse Events (AEs) [ Time Frame: Baseline up to 51.64 months ] [ Designated as safety issue: Yes ]
    Summary tables of serious adverse events (SAEs) and all other nonserious AEs are located in the Reported Adverse Event Module.

  • Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle [ Time Frame: Baseline up to 51.64 months ] [ Designated as safety issue: No ]
    RSSC is a valid and reliable measure of psychological and physical distress of cancer patients. Overall QOL is assessed on a 7-point scale (1=Excellent to 7=Extremely Poor). Categories include Excellent, Good, Moderately Good, Neither Good nor Bad, Rather Poor, Poor, and Extremely Poor. Number of responses to the overall QOL by treatment arm are provided. Arms A (Docetaxel and Gemcitabine 3 Weekly) and B (Paclitaxel and Gemcitabine 3 Weekly) were assessed every 3 weeks. Arms C (Docetaxel and Gemcitabine Weekly) and D (Paclitaxel and Gemcitabine Weekly) were assessed every 4 weeks.

  • Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit [ Time Frame: Baseline up to 51.64 months ] [ Designated as safety issue: No ]
    RSSC is a valid and reliable measure of psychological and physical distress of cancer patients. Overall QOL is assessed on a 7-point scale (1=Excellent to 7=Extremely Poor). Categories include Excellent, Good, Moderately Good, Neither Good nor Bad, Rather Poor, Poor, and Extremely Poor. Number of responses to the overall QOL (using the 7-point scale) by treatment arm are provided.


Enrollment: 241
Study Start Date: September 2005
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: Docetaxel and Gemcitabine (Tri-weekly)
Docetaxel and Gemcitabine (Tri-weekly)
Drug: Gemcitabine

Arm A: 1000 mg/m², 30 minute (min) intravenous (IV) infusion on Days 1 and 8, repeated every 21 days for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).

Arm B: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Arm C: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Arm D: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Other Names:
  • LY188011
  • Gemzar
Drug: Docetaxel

Arm A: 75 milligram per square meter (mg/m²), 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Arm C: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15, to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Experimental: B: Paclitaxel and Gemcitabine (Tri-weekly)
Paclitaxel and Gemcitabine (Tri-weekly)
Drug: Gemcitabine

Arm A: 1000 mg/m², 30 minute (min) intravenous (IV) infusion on Days 1 and 8, repeated every 21 days for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).

Arm B: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Arm C: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Arm D: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Other Names:
  • LY188011
  • Gemzar
Drug: Paclitaxel

Arm B: 175 mg/m², IV infusion over approximately 3 hours, followed by Gemcitabine, on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Arm D: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Experimental: C: Docetaxel and Gemcitabine (Weekly)
Docetaxel and Gemcitabine (Weekly)
Drug: Gemcitabine

Arm A: 1000 mg/m², 30 minute (min) intravenous (IV) infusion on Days 1 and 8, repeated every 21 days for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).

Arm B: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Arm C: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Arm D: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Other Names:
  • LY188011
  • Gemzar
Drug: Docetaxel

Arm A: 75 milligram per square meter (mg/m²), 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Arm C: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15, to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Experimental: D: Paclitaxel and Gemcitabine (Weekly)
Paclitaxel and Gemcitabine (Weekly)
Drug: Gemcitabine

Arm A: 1000 mg/m², 30 minute (min) intravenous (IV) infusion on Days 1 and 8, repeated every 21 days for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).

Arm B: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Arm C: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Arm D: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Other Names:
  • LY188011
  • Gemzar
Drug: Paclitaxel

Arm B: 175 mg/m², IV infusion over approximately 3 hours, followed by Gemcitabine, on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Arm D: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic diagnosis of metastatic breast cancer (MBC).
  • Prior neoadjuvant or adjuvant taxanes regimen is allowed if ≥12 months since completion of the regimen.
  • Relapsing after receiving one adjuvant/neoadjuvant chemotherapy containing an anthracycline if not clinically contraindicated.
  • Patients with measurable disease.
  • Previous hormonal therapy for adjuvant setting or metastatic disease.

Exclusion Criteria:

  • Previous chemotherapy for MBC
  • Previous chemotherapy with gemcitabine in any setting of disease
  • Patient candidable to treatment with trastuzumab.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00236899

Locations
Italy
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Avellino, Italy, 50019
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Bologna, Italy, 40100
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Brescia, Italy, 25124
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Cagliari, Italy, 09042
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Candiolo-Torino, Italy, 10060
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Casale Monferrato, Italy, 15033
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Castelfranco Veneto, Italy, 31033
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Catania, Italy, 95126
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Cuneo, Italy, 12100
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Ferrara, Italy, 44100
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Frosinone, Italy, 03100
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Genova, Italy, 16132
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Gorgonzola, Italy, 20064
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Lecce, Italy, 73100
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Mantova, Italy, 46100
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Milano, Italy, 20162
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Napoli, Italy, 80131
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Negrar, Italy, 37024
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Padova, Italy, 35128
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Parma, Italy, 43100
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Piacenza, Italy, 29100
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Pisa, Italy, 56100
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Potenza, Italy, 85028
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Reggio Calabria, Italy, 89100
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Rome, Italy, 00161
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San Sisto, Italy, 06156
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Sassari, Italy, 07100
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Taormina, Italy, 98039
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Torino, Italy, 10126
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Trento, Italy, 38100
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Treviglio, Italy, 24047
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Trieste, Italy, 34142
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Udine, Italy, 33100
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Viterbo, Italy, 01100
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Chair: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00236899     History of Changes
Other Study ID Numbers: 9846, B9E-IT-S376
Study First Received: October 7, 2005
Results First Received: July 25, 2011
Last Updated: August 22, 2011
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Docetaxel
Paclitaxel
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
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 24, 2014