Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
National University Hospital, Singapore |
---|---|
Information provided by: | National University Hospital, Singapore |
ClinicalTrials.gov Identifier: | NCT00212069 |
Tumors are heterogeneous with varying response to chemotherapeutic agents. We hypothesize that tumors that are sensitive to a particular chemotherapeutic agent have a distinctive tumor protein profile compared to those that are resistant. We further hypothesize that since tumor is continuously perfused by serum, serum protein profile can be used as a surrogate marker of tumor protein profile. The primary objective of this study is to identify a serum protein profile that predicts gemcitabine/carboplatin sensitivity or resistance in breast cancer patients with prior exposure to anthracyclines and taxanes. Secondary objectives are to establish the serum protein profile of breast cancer patients who have had prior exposure to anthracyclines and taxanes, and to study the pharmacogenetics of gemcitabine toxicity by correlating germline genotype of transporters and drug metabolizing enzymes with plasma and intracellular gemcitabine pharmacokinetics.
Condition | Intervention | Phase |
---|---|---|
Metastatic Breast Cancer |
Drug: gemcitabine, carboplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Serum Protein Profiling as a Predictor of Gemcitabine Sensitivity in Breast Cancer With Prior Exposure to Anthracyclines and Taxanes |
Estimated Enrollment: | 30 |
Study Start Date: | March 2004 |
Metastatic breast cancer patients previously treated with anthracyclines and taxanes will be treated with gemcitabine and carboplatin every 3 weeks.
Serial plasma samples will be collected for proteomics profiling with SELDI-MS that will be correlated with tumor response to identify biomarkers that may predict for chemotherapy sensitivity.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate organ function including the following:
White blood cells (WBC) >= 3.5 x 109/L Absolute neutrophil (segmented and bands) count (ANC) >= 1.5 x 109/L Platelets >= 100 x 109/L Haemoglobin >= 9g/dL
Bilirubin <= 1.5 x upper limit of normal (ULN), ALT or AST <= 2.5x ULN, (or <5 X with liver metastases) Alkaline phosphatase <= 2.5x ULN.
Creatinine clearance >30ml/minute, based on the Cockcroft formula
Exclusion Criteria:
Contact: Soo-Chin Lee, MD | 65-6772-4621 | Lee_Soo_Chin@nuh.com.sg |
Contact: Boon-Cher Goh, MD | 65-6772-4621 | Goh_Boon_Cher@nuh.com.sg |
Singapore | |
National University Hospital | Recruiting |
Singapore, Singapore | |
Contact: Soo-Chin Lee, MD 65-6772-4621 Lee_Soo_Chin@nuh.com.sg | |
Contact: Boon-Cher Goh, MD 65-6772-4621 Goh_Boon_Cher@nuh.com.sg |
Principal Investigator: | Soo-Chin Lee, MD | Consultant |
Study ID Numbers: | BR01/12/03 |
Study First Received: | September 13, 2005 |
Last Updated: | May 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00212069 History of Changes |
Health Authority: | Singapore: Health Sciences Authority |
breast cancer serum proteomics gemcitabine carboplatin chemotherapy sensitivity |
Antimetabolites Radiation-Sensitizing Agents Immunologic Factors Skin Diseases Breast Neoplasms Carboplatin |
Gemcitabine Immunosuppressive Agents Antiviral Agents Taxane Breast Diseases |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Enzyme Inhibitors |
Carboplatin Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Gemcitabine Breast Diseases |