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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 |
Drug: docetaxel Drug: filgrastim Drug: gemcitabine hydrochloride Drug: pegfilgrastim |
Phase II |
| MedlinePlus related topics: | Cancer Soft Tissue Sarcoma |
| ChemIDplus related topics: | Filgrastim Docetaxel Gemcitabine hydrochloride Gemcitabine Pegfilgrastim |
| 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 |
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 | |||||
| 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: Nabil Saba, MD 404-778-1900 | |||||
| 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: Clinical Trials Office - Dana-Farber/Harvard Cancer Center 617-582-8480 | |||||
| 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 | |||||
| Oregon Health and Science University Cancer Institute | 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 | |||||
| Sarcoma Alliance for Research through Collaboration |
| National Cancer Institute (NCI) |
| Investigator: | Kathleen Marsh | 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
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Kilgour-Christie J, Czarnecki A: Pulmonary adverse drug reactions in patients treated with gemcitabine and a combination of gemcitabine and a taxane. [Abstract] J Clin Oncol 23 (Suppl 16): A-8274, 796s, 2005.
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| Study ID Numbers: | CDR0000341555, SARC003, NCI-04-C-0001, MAYO-79-2003 |
| First Received: | December 10, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00073983 |
| Health Authority: | Unspecified |
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