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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00192101 |
This is an open label, two arms, randomized, unblinded phase 2 study in patients with locally advanced or metastatic breast cancer who have been previously treated with anthracycline with/without taxane based regimen in the adjuvant/neoadjuvant or 1st line metastatic setting. Gemcitabine will be administered via intravenous infusion over approximately 30 minutes at a dose of 1250mg/m2 on days 1 and 8 of each 21-day cycle. In arm A:Cisplatin will be given via intravenous infusion over approximately 60-120 minutes at a dose of 70 mg/m2 on Day 1 of each 21-day cycle. The investigator may attempt to give Cisplatin with at least one liter of fluids for hydration and on an outpatient basis.
Patients will remain in the study until disease progression or when a maximum of six cycles have been administered. Study therapy may continue until:
Condition | Intervention | Phase |
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Metastatic Breast Cancer |
Drug: gemcitabine Drug: cisplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Phase II Study of the Combination of Gemcitabine (Gemzar) Plus Cisplatin Single Dose Versus Split Dose in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer After Failure of Anthracyclines an/or Taxanes |
Estimated Enrollment: | 100 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | July 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Prior radiotherapy must be completed at least 30 days before study entry. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment (except for alopecia). Lesions that have been radiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.
Exclusion Criteria:
Saudi Arabia | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
Jeddah, Saudi Arabia |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Study ID Numbers: | 9590, B9E-SI-S371 |
Study First Received: | September 12, 2005 |
Last Updated: | November 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00192101 |
Health Authority: | Saudi Arabia: Ministry of Health |
Cisplatin Skin Diseases Breast Neoplasms |
Gemcitabine Taxane Breast Diseases |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |