Gemcitabine Monotherapy for Metastatic Breast Cancer After Anthracycline and Taxane Regimen
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191269
First received: September 12, 2005
Last updated: March 10, 2010
Last verified: March 2010
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Purpose
To investigate efficacy, safety and PK of GEM monotherapy after prior chemotherapy with anthracycline and taxane regimen for patients with metastatic breast cancer
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Breast Cancer |
Drug: gemcitabine |
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: | A Multicenter Study of LY188011 in Anthracyclines and Taxanes Pre-treated Metastatic/Recurrent Breast Cancer |
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.
Secondary Outcome Measures:
- Duration of Response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]For responders, the minimum and maximum of the duration of complete response, duration of partial response, and duration of overall response were summarized, and the median of response duration and its 95% confidence interval were calculated using the Kaplan-Meier estimation.
- Time to Progressive Disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]Time from study enrollment to first date of disease progression. Time to disease progression was censored at date of death if death was due to other cause. The minimum and maximum of this parameter were summarized, and the median time to progression and its 95% confidence interval were calculated using the Kaplan-Meier estimation.
- Survival at 1 Year [ Time Frame: baseline to date of death from any cause, evaluate at 1 year ] [ Designated as safety issue: Yes ]Results are reported as number of participants alive at one year.
- Pharmacokinetics - Normalized Cmax [ Time Frame: cycle 1 ] [ Designated as safety issue: Yes ]maximum gemcitabine plasma concentration normalized to 1250 milligrams per square meter of gemcitabine.
- Pharmacokinetics - Normalized Area Under the Curve [ Time Frame: cycle 1 ] [ Designated as safety issue: Yes ]Area under the gemcitabine plasma concentration-time curve from time zero to infinity. Gemcitabine dose was normalized to 1250 milligrams per square meter.
| Enrollment: | 68 |
| Study Start Date: | June 2005 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Dose Level 1 - 1000 mg/m2
|
Drug: gemcitabine
1000 mg/m2, intravenous (IV), day 1 and day 8 every 21 days
Other Names:
|
|
Experimental: B
Dose Level 2 - 1250 mg/m2
|
Drug: gemcitabine
1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days
Other Names:
|
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 prior chemotherapy for metastatic breast cancer with anthracycline and taxane regimen
- To have at least one measurable region
- PS: 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 carcinoma
- Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery
- To have brain metastasis with symptom
- To have severe complication (cardiac infarction, infection, drug hyper sensitivity or diabetes)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191269
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 | |
| 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 | |
| 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 | |
| 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 | |
| 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. | |
| Fukushima, 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. | |
| Gunma, 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. | |
| Hyogo, 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. | |
| Kanagawa, 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. | |
| Kumamoto, 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. | |
| Niigata, 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. | |
| Osaka, 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. | |
| Saitama, 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. | |
| Tokyo, Japan | |
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: | NCT00191269 History of Changes |
| Other Study ID Numbers: | 9065, B9E-JE-MB21 |
| Study First Received: | September 12, 2005 |
| Results First Received: | March 23, 2009 |
| Last Updated: | March 10, 2010 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Eli Lilly and Company:
|
after anthracycline taxane regimen |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Gemcitabine Taxane 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 |
ClinicalTrials.gov processed this record on June 18, 2013