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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00711243 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given with oxaliplatin and fluorouracil and to see how well they work in treating patients with metastatic or unresectable stomach cancer, gastroesophageal junction cancer, or other solid tumor.
Condition | Intervention | Phase |
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Gastric Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: docetaxel Drug: fluorouracil Drug: oxaliplatin Genetic: polymerase chain reaction Genetic: polymorphism analysis Other: high performance liquid chromatography Other: mass spectrometry Other: pharmacogenomic studies Other: pharmacological study |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Study of Taxotere, Oxaliplatin, and 5- Fluorouracil |
Estimated Enrollment: | 73 |
Study Start Date: | March 2005 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of docetaxel.
Patients receive docetaxel IV over 1 hour and oxaliplatin IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 14 days for at least 2 courses in the absence of disease progression, symptomatic tumor progression, or unacceptable toxicity.
Patients undergo blood sample collection periodically for pharmacokinetic and pharmacogenomic correlative studies. Plasma concentrations of docetaxel are analyzed by reverse-phase high performance liquid chromatography and tandem mass spectrometry. Polymorphisms in CYP3A4/5, MDR, and other genes are analyzed by PCR.
After completion of study therapy, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 73 patients (30 for phase I and 43 for phase II) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic or surgically unresectable solid tumor meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
Meets 1 of the following criteria:
PRIOR CONCURRENT THERAPY:
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Recruiting |
Chicago, Illinois, United States, 60611-3013 | |
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 cancer@northwestern.edu |
Principal Investigator: | Mary Mulcahy, MD | Robert H. Lurie Cancer Center |
Responsible Party: | Robert H. Lurie Comprehensive Cancer Center at Northwestern University ( Mary Mulcahy ) |
Study ID Numbers: | CDR0000599734, NU-0412, SANOFI - AVENTIS-NU0412, NU-948-006 |
Study First Received: | July 5, 2008 |
Last Updated: | July 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00711243 History of Changes |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific adenocarcinoma of the stomach stage III gastric cancer stage IV gastric cancer |
Antimetabolites Digestive System Neoplasms Immunologic Factors Gastrointestinal Diseases Immunosuppressive Agents Docetaxel Oxaliplatin |
Digestive System Diseases Stomach Diseases Stomach Neoplasms Fluorouracil Gastrointestinal Neoplasms Stomach Cancer Adenocarcinoma |
Antimetabolites Digestive System Neoplasms Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |
Docetaxel Neoplasms Oxaliplatin Neoplasms by Site Digestive System Diseases Stomach Diseases Therapeutic Uses Stomach Neoplasms Fluorouracil Gastrointestinal Neoplasms |