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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), June 2009
First Received: December 10, 2003   Last Updated: June 16, 2009   History of Changes
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]

Resource links provided by NLM:


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        
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        
Sponsors and Collaborators
Sarcoma Alliance for Research through Collaboration
Investigators
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

Additional Information:
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.

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

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 02, 2009