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| Sponsor: | Masonic Cancer Center, University of Minnesota |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00620295 |
Purpose
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 Other: 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.
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000586510, UMN-2006LS040, UMN-X05227 |
| Study First Received: | February 20, 2008 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00620295 History of Changes |
| 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 Anti-Infective Agents Antimetabolites, Antineoplastic Neuroectodermal Tumors, Primitive Molecular Mechanisms of Pharmacological Action Prostatic Diseases Pancreatic Neoplasms Physiological Effects of Drugs Colonic Diseases Urogenital Neoplasms Urologic Neoplasms Ileal Diseases Rectal Diseases Duodenal Neoplasms Neoplasms, Connective and Soft Tissue |
Neoplasms by Site Lung Neoplasms Therapeutic Uses Kidney Diseases Gemcitabine Breast Diseases Endocrine Gland Neoplasms Digestive System Neoplasms Genital Neoplasms, Female Breast Neoplasms Endocrine System Diseases Genital Diseases, Male Protease Inhibitors Carcinoma Neuroectodermal Tumors |