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

NCT00236899 | Completed Phase 3 Results

• 2 other identifiers: 9846B9E-IT-S376
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 34

Brief Summary

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

Conditions

Metastatic Breast Cancer (MBC)

Outcome Measures

Primary Outcomes (2)

• Time to Progressive Disease (TTPD) by Treatment Schedule

  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.

  Baseline up to 49.84 months

• Time to Progressive Disease (TTPD) by Treatment Drug

  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.

  Baseline up to 49.84 months

Secondary Outcomes (7)

• Overall Survival (OS) by Treatment Schedule

  Baseline up to 51.64 months

• Overall Survival (OS) by Treatment Drug

  Baseline up to 51.64 months

• Overall Response Rate (ORR) by Treatment Schedule

  Baseline up to 49.84 months

• Overall Response Rate(ORR) by Treatment Drug

  Baseline up to 49.84 months

• Number of Participants With Serious and Nonserious Adverse Events (AEs)

  Baseline up to 51.64 months

Study Arms (4)

A: Docetaxel and Gemcitabine (Tri-weekly)

EXPERIMENTAL

Docetaxel and Gemcitabine (Tri-weekly)

Drug: Gemcitabine; Drug: Docetaxel

B: Paclitaxel and Gemcitabine (Tri-weekly)

EXPERIMENTAL

Paclitaxel and Gemcitabine (Tri-weekly)

Drug: Gemcitabine; Drug: Paclitaxel

C: Docetaxel and Gemcitabine (Weekly)

EXPERIMENTAL

Docetaxel and Gemcitabine (Weekly)

Drug: Gemcitabine; Drug: Docetaxel

D: Paclitaxel and Gemcitabine (Weekly)

EXPERIMENTAL

Paclitaxel and Gemcitabine (Weekly)

Drug: Gemcitabine; Drug: Paclitaxel

Interventions

Gemcitabine DRUG

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.

Also known as: LY188011, Gemzar

A: Docetaxel and Gemcitabine (Tri-weekly); B: Paclitaxel and Gemcitabine (Tri-weekly); C: Docetaxel and Gemcitabine (Weekly); D: Paclitaxel and Gemcitabine (Weekly)

Docetaxel DRUG

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.

A: Docetaxel and Gemcitabine (Tri-weekly); C: Docetaxel and Gemcitabine (Weekly)

Paclitaxel DRUG

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.

B: Paclitaxel and Gemcitabine (Tri-weekly); D: Paclitaxel and Gemcitabine (Weekly)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous chemotherapy for MBC
• Previous chemotherapy with gemcitabine in any setting of disease
• Patient candidable to treatment with trastuzumab.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (34)

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.

Avellino, 50019, Italy

Location

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Bologna, 40100, Italy

Location

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Brescia, 25124, Italy

Location

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Cagliari, 09042, Italy

Location

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Candiolo-Torino, 10060, Italy

Location

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Casale Monferrato, 15033, Italy

Location

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Castelfranco Veneto, 31033, Italy

Location

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Catania, 95126, Italy

Location

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Cuneo, 12100, Italy

Location

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Ferrara, 44100, Italy

Location

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Frosinone, 03100, Italy

Location

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Genova, 16132, Italy

Location

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Gorgonzola, 20064, Italy

Location

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Lecce, 73100, Italy

Location

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Mantova, 46100, Italy

Location

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Milan, 20162, Italy

Location

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Napoli, 80131, Italy

Location

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Negrar, 37024, Italy

Location

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Padua, 35128, Italy

Location

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Parma, 43100, Italy

Location

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Piacenza, 29100, Italy

Location

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Pisa, 56100, Italy

Location

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Potenza, 85028, Italy

Location

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Reggio Calabria, 89100, Italy

Location

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Rome, 00161, Italy

Location

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San Sisto, 06156, Italy

Location

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Sassari, 07100, Italy

Location

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Taormina, 98039, Italy

Location

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Torino, 10126, Italy

Location

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Trento, 38100, Italy

Location

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Treviglio, 24047, Italy

Location

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Trieste, 34142, Italy

Location

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Udine, 33100, Italy

Location

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Viterbo, 01100, Italy

Location

Related Publications (1)

• Del Mastro L, Fabi A, Mansutti M, De Laurentiis M, Durando A, Merlo DF, Bruzzi P, La Torre I, Ceccarelli M, Kazeem G, Marchi P, Boy D, Venturini M, De Placido S, Cognetti F. Randomised phase 3 open-label trial of first-line treatment with gemcitabine in association with docetaxel or paclitaxel in women with metastatic breast cancer: a comparison of different schedules and treatments. BMC Cancer. 2013 Mar 28;13:164. doi: 10.1186/1471-2407-13-164.

  PMID: 23537313 DERIVED

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gemcitabine; Docetaxel; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

1-800-545-5979

Study Officials

• 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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2005
• First Posted: October 12, 2005
• Study Start: September 1, 2005
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: September 27, 2011
• Results First Posted: September 27, 2011

Record last verified: 2011-08

Locations

IT (34)