|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Sarcoma Alliance for Research through Collaboration |
|---|---|
| Information provided by: | Sarcoma Alliance for Research through Collaboration |
| 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, recurrent Ewing's sarcoma, or unresectable or locally recurrent chondrosarcoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Biological: filgrastim Biological: pegfilgrastim Drug: docetaxel Drug: gemcitabine hydrochloride Genetic: microarray analysis Other: laboratory biomarker analysis Other: pharmacokinetic study |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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] |
| Enrollment: | 54 |
| Study Start Date: | October 2006 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | January 2010 (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 vs recurrent Ewing's sarcoma vs unresectable or locally recurrent chondrosarcoma).
Patients receive gemcitabine intravenously over 90 minutes on days 1 and 8 and docetaxel intravenously 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.
Optional blood samples are collected at baseline and periodically during study for pharmacokinetics studies. Optional tumor tissue samples from biopsy or surgical resection are analysed for cDNA microarray analysis of gene expression.
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| Principal Investigator: | Shreyaskumar R. Patel, MD | Sarcoma Alliance for Research through Collaboration |
| Principal Investigator: | Elizabeth Fox, MD | Sarcoma Alliance for Research through Collaboration |
More Information
| Responsible Party: | Shreyaskumar Patel, MD, SARC |
| ClinicalTrials.gov Identifier: | NCT00073983 History of Changes |
| Obsolete Identifiers: | NCT00070772 |
| Other Study ID Numbers: | SARC003 |
| Study First Received: | December 10, 2003 |
| Results First Received: | March 15, 2011 |
| Last Updated: | February 8, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor chondrosarcoma recurrent osteosarcoma |
|
Chondrosarcoma Osteosarcoma Sarcoma, Ewing's Neuroectodermal Tumors, Primitive, Peripheral Sarcoma Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Bone Tissue Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Gemcitabine Docetaxel Lenograstim Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |