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Sponsors and Collaborators: |
Cancer Institute of New Jersey National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00119314 |
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, docetaxel, and capecitabine, 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 II trial is studying how well giving gemcitabine together with docetaxel and capecitabine works in treating patients with cancer of unknown primary origin.
Condition | Intervention | Phase |
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Carcinoma of Unknown Primary |
Drug: capecitabine Drug: docetaxel Drug: gemcitabine hydrochloride Procedure: positron emission tomography |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Carcinoma Unknown Primary: Treatment With Gemcitabine, Docetaxel and Capecitabine (GTX) an Evaluation and Treatment Study of The Cancer Institute of New Jersey Oncology Group |
Study Start Date: | July 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a 2-part, multicenter study.
PROJECTED ACCRUAL: Approximately 44 patients (10-29 for part 2) 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 or cytologically confirmed malignancy for which no primary origin has been identified despite routine workup, including the following:
Measurable disease
The following tumor types or presentations are excluded:
Tumors consistent with germ cell primary, as indicated by any of the following:
No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Meets 1 of the following criteria:
Renal
Gastrointestinal
Intestinal absorption intact
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New Jersey | |
Cancer Center at the Mountainside Hospital | |
Montclair, New Jersey, United States, 07042 | |
Cancer Institute of New Jersey at Hamilton | |
Hamilton, New Jersey, United States, 08690 | |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
New Brunswick, New Jersey, United States, 08903 | |
Overlook Hospital | |
Summit, New Jersey, United States, 07902-0220 | |
Hematology and Oncology Group | |
Somerset, New Jersey, United States, 08873 | |
Carol G. Simon Cancer Center at Morristown Memorial Hospital | |
Morristown, New Jersey, United States, 07962 |
Principal Investigator: | Elizabeth A. Poplin, MD | Cancer Institute of New Jersey |
Study ID Numbers: | CDR0000433512, CINJ-000404, CINJ-4735, CINJ-NJ2203, CINJ-5073 |
Study First Received: | July 12, 2005 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00119314 History of Changes |
Health Authority: | United States: Federal Government |
newly diagnosed carcinoma of unknown primary recurrent carcinoma of unknown primary |
Antimetabolites Anti-Infective Agents Neoplasms, Unknown Primary Capecitabine Immunologic Factors Antiviral Agents Immunosuppressive Agents |
Recurrence Carcinoma Docetaxel Radiation-Sensitizing Agents Neoplasm Metastasis Gemcitabine Neoplasms, Glandular and Epithelial |
Antimetabolites Anti-Infective Agents Neoplasms, Unknown Primary Capecitabine 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 Carcinoma Docetaxel Neoplasms Neoplastic Processes Pathologic Processes Radiation-Sensitizing Agents Therapeutic Uses Neoplasm Metastasis Gemcitabine Neoplasms, Glandular and Epithelial |