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| Sponsors and Collaborators: |
Sarcoma Alliance for Research through Collaboration National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00073983 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining gemcitabine with docetaxel may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with docetaxel in treating patients who have recurrent osteosarcoma (closed to accrual as of 12/21/06), recurrent Ewing's sarcoma, or unresectable or locally recurrent chondrosarcoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Biological: filgrastim Biological: pegfilgrastim Drug: docetaxel Drug: gemcitabine hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Study Of Sequential Gemcitabine Followed By Docetaxel For Recurrent Ewing's Sarcoma, Osteosarcoma, Or Unresectable Or Locally Recurrent Chondrosarcoma [SARC Study] |
| Estimated Enrollment: | 120 |
| Study Start Date: | October 2006 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized, multicenter study.
Patients are stratified according to diagnosis (recurrent osteosarcoma [closed to accrual as of 12/21/06] vs recurrent Ewing's sarcoma vs unresectable or locally recurrent chondrosarcoma).
Patients receive gemcitabine IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 9 and continuing until blood counts recover. Patients may receive pegfilgrastim SC on day 9 (once per course) as an alternative to G-CSF. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 1 year.
PROJECTED ACCRUAL: A maximum of 120 patients (40 per stratum) will be accrued for this study within 17-24 months.
Eligibility| Ages Eligible for Study: | 4 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed* diagnosis of 1 of the following:
Recurrent high-grade osteosarcoma (closed to accrual as of 12/21/06) or Ewing's sarcoma
Chondrosarcoma
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Serum creatinine ≤ ULN for age:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, California | |
| Century City Doctor's Hospital | Recruiting |
| Los Angeles, California, United States, 90067 | |
| Contact: Sant P. Chawla, MD 310-552-9999 | |
| Sarcoma Oncology Center | Recruiting |
| Santa Monica, California, United States, 90403 | |
| Contact: Sant P. Chawla, MD 310-552-9999 santchawla@aol.com | |
| United States, District of Columbia | |
| Washington Cancer Institute at Washington Hospital Center | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Contact: Clinical Trials Office - Washington Cancer Institute 202-877-8839 | |
| United States, Georgia | |
| Winship Cancer Institute of Emory University | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Gina Z. D'Amato, MD 404-778-5180 | |
| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
| Bethesda, Maryland, United States, 20892-1182 | |
| Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: George D. Demetri, MD 617-632-3985 gdemetri@partners.org | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | Recruiting |
| Ann Arbor, Michigan, United States, 48109-5848 | |
| Contact: Scott M. Schuetze, MD, PhD 734-615-4762 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, Oregon | |
| Knight Cancer Institute at Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239-3098 | |
| Contact: Christopher W. Ryan, MD 503-494-6594 ryanc@ohsu.edu | |
| United States, Pennsylvania | |
| Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19106 | |
| Contact: Arthur P. Staddon, MD 215-829-6088 | |
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 | |
| Investigator: | Kathleen Granlund | Sarcoma Alliance for Research through Collaboration |
| Principal Investigator: | Elizabeth Fox, MD | NCI - Pediatric Oncology Branch |
| Principal Investigator: | Shreyaskumar R. Patel, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | NCI - Pediatric Oncology Branch ( Elizabeth Fox ) |
| Study ID Numbers: | CDR0000341555, SARC003, NCI-04-C-0001, MAYO-79-2003 |
| Study First Received: | December 10, 2003 |
| Last Updated: | June 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00073983 History of Changes |
| Health Authority: | Unspecified |
|
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor chondrosarcoma recurrent osteosarcoma |
|
Antimetabolites Neuroectodermal Tumors, Primitive Immunologic Factors Osteosarcoma Immunosuppressive Agents Antiviral Agents Ewing's Sarcoma Recurrence Docetaxel Neuroectodermal Tumors Neoplasms, Connective and Soft Tissue Sarcoma, Ewing's |
Malignant Mesenchymal Tumor Soft Tissue Sarcomas Radiation-Sensitizing Agents Chondrosarcoma Peripheral Neuroectodermal Tumor Sarcoma Neuroepithelioma Osteogenic Sarcoma Gemcitabine Ewing's Family of Tumors Neuroectodermal Tumors, Primitive, Peripheral |
|
Antimetabolites Anti-Infective Agents Disease Attributes Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Docetaxel Neoplasms, Connective and Soft Tissue Sarcoma, Ewing's Pathologic Processes Therapeutic Uses Chondrosarcoma |
Gemcitabine Neoplasms by Histologic Type Osteosarcoma Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Recurrence Pharmacologic Actions Neoplasms Neoplasms, Bone Tissue Radiation-Sensitizing Agents Sarcoma Neoplasms, Connective Tissue |