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Sponsors and Collaborators: |
Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00620295 |
RATIONALE: Bortezomib may stop the growth of solid tumors by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with gemcitabine may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib and gemcitabine in treating older patients with advanced solid tumors.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Colorectal Cancer Head and Neck Cancer Kidney Cancer Lung Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer Sarcoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: bortezomib Drug: gemcitabine hydrochloride Procedure: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Bortezomib and Gemcitabine in Elderly Patients With Solid Tumors (X05227) |
Estimated Enrollment: | 30 |
Study Start Date: | March 2007 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a phase I dose escalation study of bortezomib and gemcitabine.
Patients receive gemcitabine IV over 30 minutes followed 1 hour later by bortezomib IV over 3-5 seconds on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gemcitabine and bortezomib until the maximum tolerated dose of the combination is determined.
Blood is collected periodically for pharmacokinetic and pharmacogenetic studies.
After completion of study treatment, patients are followed every 3 months for up to 1 year.
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed diagnosis of advanced non-hematologic malignancy, including any of the following:
Must have failed or become intolerant to prior standard therapy and is no longer likely to respond to such therapy (for all diseases except pancreatic cancer)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Minnesota | |
Masonic Cancer Center at University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 |
Principal Investigator: | Arkadiusz Dudek, MD | Masonic Cancer Center, University of Minnesota |
Study ID Numbers: | CDR0000586510, UMN-2006LS040, UMN-X05227 |
Study First Received: | February 20, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00620295 |
Health Authority: | United States: Federal Government |
recurrent pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer stage IV pancreatic cancer recurrent breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer male breast cancer extensive stage small cell lung cancer recurrent small cell lung cancer recurrent non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
stage IV non-small cell lung cancer recurrent colon cancer stage III colon cancer stage IV colon cancer recurrent prostate cancer stage III prostate cancer stage IV prostate cancer recurrent squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx recurrent verrucous carcinoma of the larynx stage III verrucous carcinoma of the larynx |
Thoracic Neoplasms Neuroectodermal Tumors, Primitive Prostatic Diseases Malignant mesenchymal tumor Pancreatic Neoplasms Colonic Diseases Urogenital Neoplasms Urologic Neoplasms Osteogenic sarcoma Ileal Diseases Rectal Diseases Duodenal Neoplasms Neoplasms, Connective and Soft Tissue Ewing's sarcoma Carcinoma, Adenoid Cystic |
Lung Neoplasms Metastatic squamous neck cancer with occult primary Laryngeal carcinoma Neuroepithelioma Kidney Diseases Gemcitabine Salivary Gland Diseases Breast Diseases Endocrine Gland Neoplasms Non-small cell lung cancer Digestive System Neoplasms Genital Neoplasms, Female Endocrine System Diseases Sarcoma, Clear Cell Breast Neoplasms |
Antimetabolites Anti-Infective Agents Respiratory Tract Neoplasms Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Protease Inhibitors Adnexal Diseases Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Jejunal Diseases Therapeutic Uses |