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Gemcitabine and Docetaxel in Treating Patients With Recurrent Osteosarcoma (Closed to Accrual as of 12/21/06) or Ewing's Sarcoma or Unresectable or Locally Recurrent Chondrosarcoma

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2008

Sponsors and Collaborators: Sarcoma Alliance for Research through Collaboration
National Cancer Institute (NCI)
NCI - Center for Cancer Research-Medical Oncology
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   

Drug Information available for:   Filgrastim    Docetaxel    Gemcitabine hydrochloride    Gemcitabine    Pegfilgrastim   

U.S. FDA Resources

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]

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Designated as safety issue: No ]

Estimated Enrollment:   120
Study Start Date:   October 2006
Estimated Primary Completion Date:   July 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

  • Determine the objective response rate in patients with recurrent osteosarcoma (closed to accrual as of 12/21/06) or Ewing's sarcoma or unresectable or locally recurrent chondrosarcoma treated with sequential gemcitabine and docetaxel.

Secondary

  • Determine the time to progression in patients treated with this regimen.
  • Assess the toxicity of this regimen in these patients.
  • Compare the pharmacokinetics of this regimen vs gemcitabine alone in these patients.
  • Obtain tumor samples for cRNA microarray analysis of gene expression and development of cell lines and xenotransplantation models.

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

Criteria

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

      • Progressive disease after standard therapy
      • Received no more than 2 additional salvage regimens
    • Chondrosarcoma

      • Unresectable OR locally recurrent and unable to be completely resected NOTE: *Biopsy required for isolated pulmonary recurrences
  • Measurable disease

    • At least 1 unidimensionally measurable lesion by medical imaging techniques
    • Ascites, pleural effusions, and bone marrow disease are not considered measurable disease

PATIENT CHARACTERISTICS:

Age

  • 4 and over

Performance status

  • ECOG 0-2 (≥ 18 years of age)
  • Karnofsky 50-100% (11-17 years of age)
  • Lansky 50-100% (≤ 10 years of age)

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3 (transfusion independent)
  • Hemoglobin ≥ 8.0 g/dL (transfusion allowed)

Hepatic

  • Bilirubin ≤ upper limit of normal (ULN) (except for patients with Gilbert's syndrome)
  • ALT ≤ 2.5 times ULN

Renal

  • Creatinine clearance or radioisotope glomerular filtration rate > 70 mL/min/1.73 m^2 OR
  • Serum creatinine ≤ ULN for age:

    • Ages 5 and under ≤ 0.8 mg/dL
    • Ages 6 to 10 ≤ 1.0 mg/dL
    • Ages 11 to 15 ≤ 1.2 mg/dL
    • Ages 16 to 18 ≤ 1.5 mg/dL

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • Sensory or motor neuropathy due to prior chemotherapy ≤ grade 1
  • Sensory or motor neuropathy due to prior surgery or tumor involvement ≤ grade 2 AND stable or improving
  • No active or uncontrolled infection
  • No known hypersensitivity reaction to docetaxel or other polysorbate 80-formulated agents

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 72 hours since prior filgrastim (G-CSF)
  • No prior allogeneic transplantation
  • No concurrent immunotherapy

Chemotherapy

  • At least 2 weeks since prior myelosuppressive therapy
  • At least 6 months since prior myeloablative therapy
  • No prior gemcitabine
  • No prior taxanes
  • No other concurrent chemotherapy

Endocrine therapy

  • Concurrent hormonal therapy allowed

Radiotherapy

  • At least 6 weeks since prior local radiotherapy
  • At least 4 months since prior extensive radiotherapy to more than 50% of the pelvis
  • At least 4 months since prior cranial spinal radiotherapy
  • At least 6 months since prior total body irradiation
  • No concurrent radiotherapy

Surgery

  • No concurrent surgery

Other

  • Recovered from all prior therapy
  • No other concurrent investigational anticancer therapy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073983

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: 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
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        

Sponsors and Collaborators
Sarcoma Alliance for Research through Collaboration
National Cancer Institute (NCI)
NCI - Center for Cancer Research-Medical Oncology

Investigators
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  This link exits the ClinicalTrials.gov site
 

Publications:
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.
 

Study ID Numbers:   CDR0000341555, SARC003, NCI-04-C-0001, MAYO-79-2003
First Received:   December 10, 2003
Last Updated:   November 21, 2008
ClinicalTrials.gov Identifier:   NCT00073983
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor  
chondrosarcoma  
recurrent osteosarcoma  

Study placed in the following topic categories:
Neuroectodermal Tumors, Primitive
Ewing's family of tumors
Malignant mesenchymal tumor
Osteosarcoma
Osteogenic sarcoma
Recurrence
Soft tissue sarcomas
Docetaxel
Neuroectodermal Tumors
Neoplasms, Connective and Soft Tissue
Ewing's sarcoma
Sarcoma, Ewing's
Peripheral neuroectodermal tumor
Chondrosarcoma
Sarcoma
Neuroepithelioma
Gemcitabine
Neuroectodermal Tumors, Primitive, Peripheral

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Disease Attributes
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
Neoplasms
Neoplasms, Bone Tissue
Pathologic Processes
Radiation-Sensitizing Agents
Therapeutic Uses
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on November 30, 2008




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