Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00334802
First received: June 6, 2006
Last updated: March 10, 2010
Last verified: March 2010
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Purpose
To investigate efficacy, safety and PK of gemcitabine and paclitaxel combination in patients with metastatic breast cancer after adjuvant/neo-adjuvant chemotherapy with anthracycline regimen
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Breast Cancer |
Drug: gemcitabine Drug: paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Combination Study of LY188011 and Paclitaxel in Patients With Metastatic/Recurrent Breast Cancer After Neo-adjuvant/Adjuvant Chemotherapy With Anthracycline |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Tumor Response [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. Responders are patients with complete response or partial response.
Secondary Outcome Measures:
- Duration of Response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
- Time to Progressive Disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.
- Number of Participants Alive at One Year (1-Year Survival) [ Time Frame: baseline to date of death from any cause, evaluated at 1 year ] [ Designated as safety issue: Yes ]
- Pharmacokinetics - Maximum Plasma Concentration (Cmax) [ Time Frame: cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes) ] [ Designated as safety issue: Yes ]Maximum plasma concentration of gemcitabine plus paclitaxel on Day 1, Cycle 1, and gemcitabine monotherapy on Day 8, Cycle 1.
- Pharmacokinetics - Area Under the Concentration Curve (AUC) [ Time Frame: cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes) ] [ Designated as safety issue: No ]Area under the concentration curve from time zero to infinity.
- Pharmacokinetics - Half Life (t½) [ Time Frame: cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes) ] [ Designated as safety issue: No ]Apparent elimination half-life.
| Enrollment: | 62 |
| Study Start Date: | June 2006 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: gemcitabine
Phase 1: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles (dose escalation) Phase 2: dose determined by phase 1 Other Names:
Drug: paclitaxel
Phase 1: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles Phase 2: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles |
Eligibility| Ages Eligible for Study: | 20 Years to 74 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically and/or cytologically confirmed breast cancer
- Received adjuvant/neo-adjuvant chemotherapy for breast cancer with anthracycline regimen
- To have at least one measurable region
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- To have adequate organ function (bone marrow, liver and renal function)
Exclusion Criteria:
- To have interstitial pneumonia or pulmonary fibrosis
- To have inflammatory breast cancer
- Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery
- To have brain metastases with symptoms
- To have severe complication (cardiac infarction, infection, drug hypersensitivity or diabetes)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00334802
Locations
| Japan | |
| 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. | |
| Aichi, Japan, 464-8681 | |
| 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. | |
| Chiba, Japan, 296-8602 | |
| 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. | |
| Ehime, Japan, 790-0007 | |
| 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. | |
| Fukuoka, Japan, 814-0180 | |
| 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. | |
| Gunma, Japan, 373-8550 | |
| 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. | |
| Hiroshima, Japan, 737-0023 | |
| 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. | |
| Hokkaido, Japan, 060-0006 | |
| 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. | |
| Iwate, Japan, 020-8505 | |
| 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. | |
| Kagoshima, Japan, 892-0833 | |
| 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. | |
| Kanagawa, Japan, 259-1193 | |
| 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. | |
| Kumamoto, Japan, 862-8505 | |
| 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. | |
| Osaka, Japan, 590-0064 | |
| 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. | |
| Saitama, Japan, 338-8553 | |
| 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. | |
| Shizuoka, Japan, 430-8558 | |
| 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. | |
| Tokyo, Japan, 104-8560 | |
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: | NCT00334802 History of Changes |
| Other Study ID Numbers: | 9066, B9E-JE-MB22 |
| Study First Received: | June 6, 2006 |
| Results First Received: | May 29, 2009 |
| Last Updated: | March 10, 2010 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Gemcitabine 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 May 21, 2013