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Phase III Study of Two Different Schedules (Weekly and Tri-Weekly) of Combination of Gemcitabine and Two Taxanes in MBC
This study is currently recruiting participants.
Verified by Eli Lilly and Company, November 2008
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00236899
  Purpose

Multi center randomized phase III study, 4 arms. 360 Patient to enroll. Purpose is evaluate time to progression disease


Condition Intervention Phase
Metastatic Breast Cancer (MBC)
 Drug: gemcitabine
Drug: docetaxel
Drug: paclitaxel
 Phase III

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Docetaxel Gemcitabine hydrochloride Gemcitabine Paclitaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Time to progression [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacology toxicity and Quality of Life [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
  • Overall response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: September 2005
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental Drug: gemcitabine

A: 1000 mg/m2, IV, day 1 and day 8 q 21 days x 8 cycles or disease progression

B: 1250 mg/m2, IV, day 1 and day 8 q 21 days x 8 cycles or disease progression

C: 800 mg/m2, IV, days 1, 8 and 15 q 28 days x 8 cycles or disease progression

D: 800 mg/m2, IV, days 1, 8 and 15 q 28 days x 8 cycles or disease progression

Drug: docetaxel

A: 75 mg/m2, IV, q 21 days x 8 cycles or disease progression

C: 30 mg/m2, IV, days 1, 8 and 15 q 28 days x 8 cycles or disease progression
B: Experimental Drug: gemcitabine

A: 1000 mg/m2, IV, day 1 and day 8 q 21 days x 8 cycles or disease progression

B: 1250 mg/m2, IV, day 1 and day 8 q 21 days x 8 cycles or disease progression

C: 800 mg/m2, IV, days 1, 8 and 15 q 28 days x 8 cycles or disease progression

D: 800 mg/m2, IV, days 1, 8 and 15 q 28 days x 8 cycles or disease progression

Drug: paclitaxel

B: 175 mg/m2, IV, q 21 days x 8 cycles or disease progression

D: 80 mg/m2, IV, days 1, 8 and 15 q 28 days x 8 cycles or disease progression
C: Experimental Drug: gemcitabine

A: 1000 mg/m2, IV, day 1 and day 8 q 21 days x 8 cycles or disease progression

B: 1250 mg/m2, IV, day 1 and day 8 q 21 days x 8 cycles or disease progression

C: 800 mg/m2, IV, days 1, 8 and 15 q 28 days x 8 cycles or disease progression

D: 800 mg/m2, IV, days 1, 8 and 15 q 28 days x 8 cycles or disease progression

Drug: docetaxel

A: 75 mg/m2, IV, q 21 days x 8 cycles or disease progression

C: 30 mg/m2, IV, days 1, 8 and 15 q 28 days x 8 cycles or disease progression
D: Experimental Drug: gemcitabine

A: 1000 mg/m2, IV, day 1 and day 8 q 21 days x 8 cycles or disease progression

B: 1250 mg/m2, IV, day 1 and day 8 q 21 days x 8 cycles or disease progression

C: 800 mg/m2, IV, days 1, 8 and 15 q 28 days x 8 cycles or disease progression

D: 800 mg/m2, IV, days 1, 8 and 15 q 28 days x 8 cycles or disease progression

Drug: paclitaxel

B: 175 mg/m2, IV, q 21 days x 8 cycles or disease progression

D: 80 mg/m2, IV, days 1, 8 and 15 q 28 days x 8 cycles or disease progression

  Eligibility

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

Inclusion Criteria:

  • histologic diagnosis of MBC.
  • Prior neoadjuvant or adjuvant taxanes regimen.
  • Relapsing after receiving one adjuvant/neoadjuvant chemotherapy containing an anthracycline.
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00236899

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) 1-317-615-4559

Locations
Italy
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Avellino, Italy, 50019
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Bologna, Italy, 40100
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Brescia, Italy, 25124
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Candiolo-Torino, Italy, 10060
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Casale Monferrato, Italy, 15033
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Cuneo, Italy, 12100
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Cagliari, Italy, 09042
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Castelfranco Veneto, Italy, 31033
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Catania, Italy, 95126
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Ferrara, Italy, 44100
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Frosinone, Italy, 03100
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Genova, Italy, 16132
Contact: Eli Lilly            
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Gorgonzola, Italy, 20064
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Lecce, Italy, 73100
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Mantova, Italy, 46100
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Milano, Italy, 20100
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Napoli, Italy, 80131
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Viterbo, Italy, 01100
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Piacenza, Italy, 29100
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Padova, Italy, 35128
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Parma, Italy, 43100
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Pisa, Italy, 56100
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Potenza, Italy, 85028
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Reggio Calabria, Italy, 89100
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Rome, Italy, 00161
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Sassari, Italy, 07100
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
San Sisto, Italy, 06156
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Torino, Italy, 10126
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Trento, Italy, 38100
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Trieste, Italy, 34142
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Taormina, Italy, 98039
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Treviglio, Italy, 24047
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Udine, Italy, 33100
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Negrar, Italy, 37024
Contact: Eli Lilly            
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

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

Responsible Party: Eli Lilly ( Chief Medical Officer )
Study ID Numbers: 9846, B9E-IT-S376
Study First Received: October 7, 2005
Last Updated: November 18, 2008
ClinicalTrials.gov Identifier: NCT00236899  
Health Authority: Italy: Ministry of Health

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

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

ClinicalTrials.gov processed this record on January 16, 2009



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